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1 haven’t been missed and so forth. But I’m actually
__—_
2 relatively struck that the adverse events are mostly

3 transient, and those that are not are ones that pretty much

4 could be expected for the disease.

5 I personally don’t have any that just rea;.ly

6 strikes out in my mind as being something that is of a major

7 concern, except to continue to look at it and monitor it.

8 I think No. 4 is pretty much the same question. I

9 think it’s been answered. I think the consensus here is

10 that additional--if not necessarily studies, additional data

11 monitoring and collection is necessary. I think certainly

12 in a Phase 4 study, it can actually be incorporated into a

13 Phase 4 study without much more expense. So I’d like to go

14 ahead and move on to Question 5 if that’s okay with the

15 panel.

16 Is there any--okay. Good . And it’s actually a

17 little past 3:30 now--what time is it? A little past 2:40

18 now. Instead of taking a break, there’s only two other

19 questions. I think if we can just get through these, it

20 will probably be better. Certainly some people who have to

21 catch an early flight, it would serve their needs also.

22 Okay. No. 5, Other issues related to the safety

23 or efficacy of the product? Any other issues? Dr. Fong,

24 can you start us off there?

25 DR. FONG: Nothing more than what I’ve said

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1 already.

2 CHAIRMAN WILSON: Okay. Dr. Chew?

3 DR. CHEW: I don’t have any more to add.

4 CHAIRMAN WILSON: Dr. Hannush?

5 DR. HANN_USH: Ncthing more to add.

6 CHAIRMAN WILSON: Dr. Kilpatrick?

7 DR. KILPATRICK: No, nothing.

8 CHAIRMAN WILSON: Anybody want to add anything to

9 this?

10 [No response.]

11 CHAIRMAN WILSON: Okay. I also don’t have

12 anything to add on this subject.
,’ ,.

_—- 13 No. 6, are the data considered sufficient to

14 support an indication in patients with CMV retinitis who

15 i-ave failed, or demonstrated intolerance to, at least

16 [questionable] other treatments for CMV retinitis?

17 I think the question here--Wiley, did you want us

18 to speculate about certain numbers of failed treatments or--

19 DR. KILPATRICK: May I ask Dr. Chambers also to

20 explain what--I just do not understand what is being asked

21 here .

22 CHAIRMAN WILSON: Yes .

23 DR. CHAMBERS: This was assuming that we got to

24 the point where the panel, the committee was going to--they

25 were recommending approval of the product. The question was

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1 what indication that we then were dealing with, and the

2 question mark is there because it could be filled in with a

3 O, which essentially would mean primary therapy. It could

4 be filled in with a 1 or 2, meaning some type of level of

5 prior failure or intolerance to that. So I would both like

6 that number to be filled in, and I would like to see a hand

7 vote at this point for this question. That does not

8 necessarily mean you need to--the hand vote may end up being

9 some people saying a O is the most appropriate thing in

10 there, some people saying a 1, some people saying a 2. Just

11 what most fits in there, or some people saying no, it

12 shouldn’t be approved at this point. So I think there are

13 probably at least four options to that.

14 CHAIRMAN WILSON: Okay. I think actually we

15 discussed some of this in the first question, but this would

16 be a way to formalize, I think, the response a little bit

17 better. So if we can do a hand vote, and I think the four

18 options would be: one, no approval; two, approval as--well,

19 O would be there are other treatments that would be a

20 primary treatment; and then one other treatment or two other

21 treatments . Okay?

22 DR. HANNUSH: Can I possibly play the role of a

23 peacemaker here and is there a way to avoid that distinction

24 but put a lot of cautionary statements in the labeling?

25 This is a question of Dr. Chambers.

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1 DR. CHAMBERS: Well, I guess I would turn that

2 back to--we would certainly be interested in comments that

3 anybody on the committee had of a way to properly convey to

4 people the uncertainty that certainly has been expressed by

5 members of this committee to the public should this product

6 be approved.

7 DR. HANNUSH: Well, my thoughts would be basically

8 saying that, you know, in the process--I don’t know exactly

9 how labeling takes place, but in the process of approving

10 this drug, it was felt that it was important to bring it to

11 market, yet there were concerns about the sample data and

. .
12 the size of the sample data, and, therefore, the conclusions

.. .. 13 that were made were not based on sound statistical

14 principles, yet there was enough feeling that this should be

15 approved to make it available to the public. Or is that

16 really weak?

17 [Laughter.]

18 DR. DeLAP: I might chime in with just a couple of

19 other thoughts. I think what I personally am most

20 interested in is the up or down votes, yes or no, and then

21 knowing what the sentiments are of the individual members

22 when it comes to the O, 1, or 2 kinds of issues. So perhaps

23 we could just have a hand showing for the primary question

24 of, yes, approve or, no, don’t approve, and then we can hear

25 what the sentiments are, again, from the individual members,

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1 whether they think it should be O or 1 or 2 plugged into
.—=
2 that box. I think that would suffice for us. Then we can

3 struggle with these issues of the exact labeling.

4 The labeling does have to be driven by science.

5 Ne recognize that there are sccia. problems in our society

6 with the way medical care is delivered, and I think we’re

7 troubled by that and we’re troubled by the fact that

8 sometimes the way we label products is used as an excuse not

9 to treat people the way they should be treated. I think we

10 recognize that, and we’re sympathetic to it, and we’re

11 struggling with how best to deal with it.

12 In the end, I think we all just need the answers--

_—_
13 need the--there’s the access questions and the answers that

14 I think we have to deal with here. One is that people need

15 to have access to the treatments that they need. People

16 also have to have the answers to the questions that need to

17 be answered so that they get treated right. And so we have

18 to insist that the research is done to really understand if

19 the products are used appropriately, say front-line. And,

20 again, we also have to be sympathetic to the other issues

21 that you raised so eloquently.

22 MR. FROST: I just want to say one thing. You

23 know, I’ve said publicly and I’ve actually written publicly,

24 Dr. DeLap, that I don’t think the problems of a failed

25 health care system should be thrown on the doorstep of the

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1 FDA . So I’m very sympathetic to the comments that you’ve

A just made. I do think the labeling has to be driven by

3 science. But it can’t be driven by science in a vacuum, and

4 so I think we all recognize that we are subject to the

5 environment in which we l;.ve, and that’s the environment in

6 which we have to try to make these kinds of decisions.

7 I just want to say that in this particular

8 context, it’s my opinion that the burden for making this

9 distinction really lies with the agency, because five other

10 products have been approved in this conLext in which no

11 distinction, as this, was made. So if there’s a reason for
,.,
12 making such a distinction, I think the burden really lies


—— 13 with the agency to make it clear why that distinction is

14 necessary and what function you really think it will serve.

15 ~ecause I’m perfectly open to being convinced that it will

16 serve a useful function, but I’ve yet to hear what that is,

17 and I’m yet to be convinced in this context that this

18 product is special in that regard. And if so, I’d like to

19 know how.

20 DR. DeLAP May I just turn it back and say we just

21 want to know what you think of the science here, and we’ll

22 work with your--

23 MR. FROST: Oh, well, we’ll try t.o let you know

24 that .

25 DR. DeLAP: Okay.

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1 [Laughter.]
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2 CHAIRMAN WILSON: What I’d like t.o do then is have

3 two votes. The first vote is just a straightforward yes-no.

4 Yes for approval, no for non-approval. And then we’ll go on

5 to a second vote, which would be filling in that blanks with

6 commentary. The first vote, please, will be all in favOr--

7 MR. FROST: A point of information, Mr. Chairman.

8 Some of the members here I think are non-voting as

9 consultants, and maybe Ms. McGoodwin could make that--

10 MS. McGOODWIN: Yes. As long as the person is a

11 special government employee, which three of our four

12 consultants are, we’ve gotten them voting privileges.

n 13 MR. FROST: So I’m the only one not voting.

14 MS. McGOODWIN: Correct.

15 MR. FROST: Right . Well, I think everybody knows

16 how I feel.

17 [Laughter.]

18 CHAIRMAN WILSON: Of those that are eligible to

19 vote, please raise your hand if you vote for approval.

20 [A show of hands.]

21 CHAIRMAN WILSON: Non-approva 1?

22 [A show of hands.]

23 CHAIRMAN WILSON: Okay. Now , of the five, if we

24 can start with Dr. Mathews, your views on the second part of

25 this question, which is 1, 2, or 3 of the treatments, or O

MILLER REPORTING COMPANY, INC.
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1 )f the treatments; in other words, primary versus treatment
-~.
2 ;ailures. And feel free to do whatever commentary related

3 LO this.

4 DR. MATHEWS: Well, I am, as I said earlier,

5 mcomfortable with one or two drugs or, you know, having

6 :ailed local therapy versus systemic. I mean, there’s a

7 ~hole bunch of different scenarios you could spin out.

8 My real concern is that this drug has not been

9 ;tudied to the same degree in the same environment as the

10 ]revious agents. With all of the ocher agents that have

11 >een studied, the issues about immune restoration were not

12 >art of the scenario that was looked at. And now this drug

13 ras caught in the middle of its development cycle in this

14 ~ilemma, and it’s going to be the same situation for further

15 ~evelopment plans. And I don’t think we can just blow that

16 >ff and say, well, the crude effects of the treatment are

17 #hat drives everything. That’s not convincing.

18 Therefore, I would not say one or two drugs that

19 failed. I think the labeling should make it very clear that

20 ~his agent is a new agent, has a lot of advantages in terms

21 of cross-resistance, potentially, but it has been studied

22 less intensively than other agents, and there is some data

23 to support its use in primary therapy as well as secondary

24 therapy, but the level of confidence in the magnitude of the
.—=
25 treatment effect I think has been overstated or potentially

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1 cwerstated by the sponsor. That’s not to say that it’s not
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2 there, but I think it will shrink if the controls we’ve

3 talked about are rigorously employed.

4 CHAIRMAN WILSON: Dr. Hannush?

5 DR. HANNUSH: In answer :0 the agency’s request

6 that we come up with a number, my vote is to place the

7 integer 1 in that category. My comment--and I think Dr.

8 Mathews eloquently answered Mr. Frost’s concern--is to say

9 that the previous drugs did not have this restriction on

10 them, also the answer to--that is true, but the answer to

11 that is, if I recall correctly, when--I was only involved in
,..
12 one of the approvals. The science was overwhelming at the

–—.= 13 time. So, in fairness here, the science is limited. So if

14 Mr. Frost or others wanted to push the issue, the science

15 simply doesn’t carry over the way I see it. Therefore, I

16 choose the number 1.

17 CHAIRMAN WILSON: Dr. Chew?

18 DR. CHEW: I would agree with Dr. Mathews in the

19 way of, I think, explaining the way that the trials have

20 been done and the way the trials have been conducted, in

21 particular this drug compared to others. But I really can’t

22 give you a number based on the data we have on hand. I

23 think that’s what Phase 4 is going to tell us, so I really

24 can’t say that on the label say you’re going to have to try

25 at least these number of drugs. I think it would be very

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1 ~rroneous for us to sit here and say this is what we think

2 is going to happen. So I vote for O.

3 CHAIRMAN WILSON: Dr. Fong?

4 DR. FONG: One.

5 CHAIRMAN WILSON: Let me see. Yc)u voted against,

6 so I don’t think we need to--okay.

7 MS. COHEN: Can I just make a comment, if it gets

8 approved, about the labeling? I mean, the labeling has to

9 say that the science is limited and they dcm’t have enough

10 2XP erience. And I’m sitting here and i illshaking my head,

11 and I’m hearing people say the science is limited, but

12 they’ve approved. So I don’t understand our function. ..-

13 DR. MATHEWS: You know, one of the things that I

14 think is very helpful about CMV retinitis is that if

15 s>mebody has regular follow-up, they’re not. going to get

16 into a lot of trouble with a competent ophthalmologist. In

17 the patients that we take care of who, for example, are

18 withdrawn from all CMV therapy, they are seen every month,

19 and it’s fairly easy with a proper examination to tell

20 reactivation.

21 If this were an indication for CMV encephalitis

22 or, you know, colitis or something, there would be big

23 problems. But that fortunately is not what we’re talking

24 about today.

25 CHAIRMAN WILSON: I think that the data is less

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1 compelling for primary treatment than for re-treatment.

2 Nonetheless, I would agree that to put a restriction on it

3 night be counterproductive, and I think that more data is

4 ~ecessary through other studies to take a look at this. So

~ I would probably put O and just continue tc~ look at this--

6 the data is there. It’s just not as compelling.

7 lmy other final comments by any clf the panelists,

8 any of the committee?

9 [No response.]

10 CHAIRMAN WILSON: Wiley, do yuu hlave any final

11 :omments? Is there anything else you’d like for us to

12 uonsider? ,’

13 DR. CHAMBERS: I do not at the time, except to

14 thank the committee very much for their careful

15 Deliberations and discussion. We will take the advice that

16 we have heard under consideration , and we will make various

17 decisions based on it .

18 Again, I thank you very much for your input.

19 CHAIRMAN WILSON : The meeting is adjourned.

20 [Whereupon, at 2:53 p.m., the meeting was

21 adjourned.]

22 ---

MILLER REPORTING COMPANY, INC.
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Opthahic Drugs Subcommittee of the
Dermatologic and Optha.lmic Drug Advi80ry Crete
Jtiy22,1998
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%f$ll-=~Da-.--.-s---- -. _ . . .
Opthalmic Drugs Subcommittee of the
July 22, 1998 Dermatologic and Opthaknic Drug Advisory Crete

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,11,15,20, 25; 50:9, !5; 168:2,6, 12, 14, 15, 162:13;163:1, 17; 170:2, 132:5;133:19,21; 138:20; advanced 7:11; 81:22;
,51:14 ;53:5, 13, 15; [8,21, 25; 169:3,5,15, [6, 24; 173:18; 176:7, 17; 146:13;147:8, 24; 152:2; B5:13;115:24; 116:1
54:9,18, 20; 55:1,3,7,14, [9, 23; 170:6,7,9,9,10, [82:12; 183:11, 25; 16&6; 172:16; 174:10, 14;
rndvancement 25:14;
15;56:3,4, 17; 57:3,12, [9, 23; 171:15,17, 18; 184:23;185:1, 14; 187:21; 178:21;185:18;201::1, 12,
118:21,24; 119:1, 20;
19,23; 58:10, 20; 59:4, 19; [72:1, 1,2,4,6, 13; 188:8;195:23; 1%:18; 16;203:14; 205:23
120:4
60:4,6, 18,25;61:7, 14, [73:14, 19,20, 24; 175:7; 197:7,22; 199:4, 5,9; acuities 67:16; 150:17,
24;62:4,4,5,5,10,18, 23; 176:5;177:9,11, 23; 202:18;204:11;208:11; Bdvancing 117:12;
23;153:19; 156:13,14
63:5; 64:1,4,6, 11,16,22, 178:12,20; 179:4,9; 209:3;210:8, 14,24 130:24
lCUity 25:19; 49:11, 13;
24;65:14, 16;66:2,4,13, 180:10,25; 181:13,15, 24; ibove 35:10; 40:8; 51:6; rndvanteges 15:5; 208:20
$0:13,16, 19,25; 51:1,5,
14,21;67:5,8,9,11; 68:6, L82:1,6,12,25, 25; 183:4, 143:25 ); 55:2, 20; 67:12,13, 13; ndvent 7:6
9;69:24;70:7, 19;71:5,5, [2, 19; 184:1,8, 15; 185:2, abroad 192:3 38:12,14,15,19, 22; adverse 26:6; 27:10;
18,21;72:1,25;73:12, 13, L 3, 10, 10, 18, 24; 186:1, absolutely 16:25;75:20; 150:18;153:1,2,7,8,,9, 41:2,6,9,10,15,22, 24;
16;74:6,9,15,16,17,22, ;, 6, 12, 13, 16, 23; 187:3, 101:10;129:7 23;154:11,18,24 ;1515:11, 42:2,22; 43:3, 24; 44:2;
24, 25;75:1, 3,18,24,24, ), 10,10,10,11,15,21, 12,20; 156:5; 157:3, 13; 47:8,16,18,20,22, 23;
mbsorb 177:15
25;76:1, 22;77:7,21, 25; 22;188:22; 189:10, 18, 19; 190:4 49:15,16, 19; 53:5,7,10,
78:13,14,14, 19;79:1,2, 190:5,7; 191:16, 25; nbstracts 163:3
rncuta43:15 11;54:10; 55:18, 18;
3,5,6,10,12,17, 23;m:4, 192:13,14,21, 23; 193:2, lcademic 23:10;64:22
d 103:16 57:24,25; 58:5,8,9,11,
20, 24;81:1, 25;82:4,6,9, [, 15,16,19,23, 25; Bccept 135:2 21,24, 25; 59:24;60:8, 14;
16, 17,23;83:2,6,22, 23; 194:3,8,14,16, 25; 195:8, mceptable 21:2;41:24; ADAP 200:7,17
79:10, 11;80:16,17, 20;
84:2,4,4,7,10,12,16, 17; 19;1%:6; 197:2,12, 16; i7:19; 54:8; 55:17;94:14; mdd133:10; 167:7,21; 97:20,23; 151:7,15,17,
85:17,22;86:1,1,3,9,11, 198:4,16,18,18,20,21, 181:20,21; 182:18 202:3,5,8,12 17; 152:3; 155:14; 169:22;
15,23;88:5,7, 15,21; ?1;199:5,11,16, 17; mccepted 13:6 mddad 57”23; 108:1; 1%:13; 198:2; 201:2
89:13, 20;90:2,15,16,17, WO:12,16; 201:6,12, 12, mccess 64:12; 186:5, 13; 148.-J, .(A5:20 dverse-patientst58:24
18;91:13,23, 24;93:9, 11, 16,17, 18; 203:2,4,6,9, 198:23;205:13,15 rndding 148:18
12,23;94:1,6, 20;95:5, dvertising 166:21
10,10,16,16,17,19,22, rnddition 7:16; 25:15;
mccessing 187:17; ktViSOty 4:5; 22:18;
11,11, 24;%:9; 97:7,9, Z3,24, 25; 204:3, 18,23; 26:4
“‘16; 98:5, 16;99:1,6, 15, 19$?12 33:2; 125:16
205:24;206:3,11,12, 16;
according 38:16; 59:1; ~dditional 13:4,5,13, 16;
15;100:21,21; 101:4,5, 207:3,5,7,10,20, 22; Advocacy 6:19,22
159:3;161:25 $1:8;72:4; 89:6; 110:10;
~15, 17,20; 102:20,25; 208:6,20, 20; 209:6, 22; advocate 57:23; 184:16
account 35:12, 20; 180:16; 183:20; 189:13;
2,4,17, 23; 104:1,3, 210:7,16,16,19 affect 88:19;9011
B1:14;14025; 160:15 192:18, 19; 1%:7, 15;
3, 20; 105:4,5,6,16, ability 140:8; 166:2; 201:10 affecting 88:18
106:8,24; 107:22; 167:3 accounted 58:5,7
108:4,7,8,10, 21; 109:3, rndditional-if 201:10 afflicted 182:2
mble 11:4; 23:22; 32:6; accounting 144:20
12,18, 23; 110:21;111:6, Additionally 89:3 afford 164:10
51:7;72:10,17, 19;73:4, accounts %:3
8, 11,20, 24; 112:20; 15;74:4, 11;75:8; 81:10; address 6:8; &14; 63: 16; African 69:8
113:2,21,24; 114:2,11, accrued 195:10 70:13; 106:15; 111:2:3;
B2:24;83:5, 16;84:21; After 9:10, 13; 14:25;
11, 15;115:9,13,14,15, accuracy 117:20 112:22,25; 119:13;
B5:7;87:19; 88:13; 97:25; 16:5;36:14; 37:19; 66:23;
16,16,18,22, 24; 116:13, 118:10; 132:10; 138:12; sccurate 87:16; lW. 1; 138:12; 162:16; 181:14 70:12,12, 14;84:22;
21,22,23,24, 25; 117:6, 140:25; 147:5; 172:11; 141:2,8 address-thank 174:6 92:21; 106:9; lo7:13;
7,8,25, 25; 118:2,8, 24; 174:8 accurately 116:9 addressed 14:14; 136:9 115:25; 118:13; 121:13;
120:4,15; 121:3,16, 16; accustomed 63:20 12723; 128:4; 139:16;
122:1,1,2,6,15,18, 19; abnormalities 18:19; addresses S:11
41:18 acetate 44:14 144:9; 151:7; 157:1,3;
123:4,8, 13; 124:7,15,20, addressing 71:8
achieve 2010 163:16; 169:12; 171:15;
24; 125:1,10, 12; 126:3,4, abnormeiiiies-and adequate 22:11; 54:5; 195:1,2
6, 11; 127:16, 18;128:11, 41:17 achieved 21:2, 4,5; 55:22; 73:14; 83:15; 89:4,
AFTERNOON 136:1;
12,14, 16,24; 129:17,19, about 9:11, 19; 10:23; 36:16; 38:1; 115:3 12; 142:13
181:13
25; 130:11,24; 131:3,5, 12:13,17,24 ;13:11,16; achieving 18:4 adequate-if 83:15
15; 132:7,9; 133:4,17,19, 15:10,24;21:16; 22:3; Again 13:20; 19:19, 22;
acquired 71:2 adequately 146:13 25:21; 28:4,6, 10; 30:25;
20, 21; 134:6,7,13,14, 23:5; 24:25; 29:18, 19;
acquisition 69:14, 19 adhesive 194:11 34:3,14, 18; 36:9; 37:24;
23; 135:6; 136:8,16,20, 30:24; 32:19 33:16;
21,21;137:8,12,21,24; 44:11, 18;45:10, 11;47:7, across 11:6; 50:13, 15; adjacent 25:18 40:14, 23; 43:16; 45:6, 8;
138:9,15, 23; 139:2,3,11, 17;49:10, 2Q 50:12; 75:9102:16,17, 20; edjectiva 194:3 46:2,3,8, 22; 47:13; 48:4;
16,22, 24; 140:1,3; 141:4, 51:11; 53:13; 55:12; 58:5, 195:13 adjudicate 94:13 49:10, 23; 50:5; 51:16, 22;
4,16,22,23, 24; 142:2, 24; 60:24; 61:5,15, 25; acting 97:10 52:7,16, 20; 53:1, 22;
adjudication 101:21 55:24; 56:18;68:1; 72:24;
25; 143:11,18,19,19, 23; 63:15; 64:9, 10, 17;65:20, sct”mn 8:3; 55:10; 56:16 adjudications 101:23 74:10; 77:16,20, 25;
144:4,5, 12; 145:20,21, 23; 67:20; 70:1; 73:9,20 active 7:6; 18:1; 23:21;
25; 146:7,11,16, 19; 74:16, 19;76:17; 78:13; adjust 31:11 79:15;80:4, 13,16, 18;
25:17; 115:23; 116:1; 82:14;84:10; 85:13, 15,
147:1,8, 15, 18,23, 25; 80:24;83:18; 84:11; adjusted 31:15,21
118:11, 14;137:12; 18, 20; 86:5,8, 22; 87:7,8;
148:12,14,18,19,20,22, 86:13, 15;88:5; 92:20; 143:22; 144:1,2,3, 25; adjusted-but 138:17
=-1: 149:3,14, 15, 23,25; 93:13;94:10, 12, 17; 88:12; 100:15; 108:13;
145:12, 14; 178:21 adjusting 31:17; 32!:25
):14; 151:6, 18; 152:1, )7:16; 98:7; 100:2; 104:3, 110:4, 13; 112:5,8;
actively 59:13 adjustment 93:8; 192:15 124:25; 136:12; 143:10;
6, 24; 153:11; 154:5, 7,13, 14; 106:17,20,22,
activ”hy 7: 15;8:3; 128:14, administered 97:21; 145:22; 148:9; 150:20;
.20,20; 155:2,3,8, 23; 23; 109:23; 112:17, 20;
19, 21; 161:14 160:25; 161:1 163:5; 171:1; 181:17;
156:5, 16, 19; 157:10; 113:2; 116:6; 117:13;
158:17,21,24; 159:2,16, 128:4; 132:4; 133:8; actual 103:1,8; 162:6; Administration 14:2; 190:12; 193:10; 195:24;
18,23; 160:4,9; 161:11; 136:16; 140:2; 141:4; 179:25 21:23; 1092; 136:24; 204:25; 205:20
162:4,8,13, 18; 163:3,9, 142:10:146:9.12. 15; actuallv 16:5; 57:7; 172:12 against 7:4, 15, 17, 21;
9,19,23,24, 25; 164:3,7, 147:3; 148:6; 149:15; 58:21, ~2; 63:16; 69:17; admitted 161:22 8:3; 17:10, 16;97:1; 133:1;
. .. . . .. –./-.
Opthalmic Drugs Subcommittee of the
Dermatologic and Opthahn.ic Drug Advisory Crete JUIY 22,1998

165:ro; 176:2; 177:12, 24; I39:1O;140:10; 142:18; 174:12;198:17 54:21;62:18; 68:5; 88:20; 13, 18;65:3,6,8,9,13, 18,
..—-.. 178:1,3,7,9, 15; 179:10; [43:24; 144:19; 145:13; am 9:4,5;10:13,25; 127:17;166:8; 193:7; 24;66:4,8, 13,14, 15,18,
210:5 147:15;148:16; 14925; [1:12,
13,17;63:15; 195:13,20 24;67:2,8,13,18,24, 24;
against-l 179:1 1502; 153:22; 154:17; 54:20;
70:18,
20;72:8; rnnaiysis 23:4; 25:16, 21; 68:6,“15,18,19, 19;69:6,
age 29:15; 180:14 156:8;16&2,7; 164:13; 77:3;
89:9;
98:6,
16; 29:6,7,7,13, 24; 30:8; B,9, 10,11,15, 17;70:1,4,
165:3,7; 168:7;171:10; 100:17;
122:5;
147:23; 31:3,3; 32:3,1$ 16;33:3; 7,8,11, 12,20; 71:9, 12,
age-sex 34:14 13, 19;72:2,5, 16;73:1,2,
174:24;175:4; 176:16; 158:15;
160:19;
162:7; }5:16; 54:14;60:18; 6$?4;
agencies 200:6 179:8;181:13;186:1; [74:2,
3;178:8;
188:8; 77:12,14;78:2IO;93:12; 5, 11;74:9, 16,20,21, 24;
agency 5:16; 12:25; 13:5, 19025; 193:11;194:6; 19&21;
191:24;
194:10; 106:2;107:2; 109:10; 75:2,6,7,9,12, 25;76:1,
10; 14:22; 15:11;23:3; 1%:7; 199:18;205:12; 204:19208:4 1102, 22; 118:18, 23; 3,4,5, 25;~l,8,9, 10,
57:10; 71:9, 12;74:2; Z06:4;207:6; 208:10; ml-i147:14 11910; 122:7,10,10, 12; 19;78:5,8,9,14,15,17,
102:1; 126:25; 165:7; 210:18 128:11;132:12; 140:1; 2};79:3, 13, 13,23, 25;
168:11; 179:12; 185:19, rnmeiioretion 67:5
gil-and 134:4 141:23;144:14; 145:17, 90:4,8, 11;81:11, 14,19,
24; 187:15,22 193:25; America 69:8,10 21;146:21; 147:10,17, 22; 21;82:1,3,4, 14, 20;83:2,
rnii-thet 134:6 American 11:25;69:8,12
199:17;206:9,13 168:12;171:13, 14; 7,18, 24;84:2,5,7,9,15,
agency’s 209:5 niioceted 21:17 Americans 69:8,12 176:22;191:19, 22; 23,24, 25;85:9,14,18,
agency-the 191:18 9iiOW6:2 Iherkas 132:15 192:11,19 18,23;86:9,18, 22;87:1,
agenda 5:15,21; 14:8; nllowence 29:3 AMFAR 12:1 analysts 119::2 10;88:1,2,3,8,9,17,20,
137:18 BiiOWSd28:6; 34:11; rnnatytic 128:16 22;89:4,9,11, 24;90:3,6,
rnmong 66:22; 127:21; 9,10,12,16, 18;91:11,
agent 104:18,22; 105:10; iO:19 48:18; 53:23; 169:13,14; 195:16 rnnaiyticai 128:9
59:22;68:4; 158:7,23; 18;92:12,17,19,20, 21;
139:11; 161:17;208:20, rnmongst 131:17 rnnalyze34:21; 133:15
20 184:18 ?3:5,6, 16,22; 94:11, 17,
mount 1022; 14:23; wraiyzed 1195; 164:16 19,21,25 ;95:7, 11, 19;
agents 16:1; 19:6; 180:5, niiowing 14:3 analyzing 62::14
3%12;43:1Q 54:21; 96:6,10,16, 19;97:7, 13,
18; 181:6; 191:6;208:10, diOWS 17:7;20:18 57:10;116:22; 193:6 and 4:4,9,9, 11; 5:2, 12, 17,20;98:6, 14;99:7,9,
10, 7? rniiuded 115:12; 136:10; mounts 78:4 15,18, 23; 6:4,16,19,22, 15,25, 25; 100:10,11,14,
aggregate 36:20; 195:15 138:19 23;7:1,5,11,1’5,20,23; 14,15,15, 21?22,25;
rnmpiify 58:20
ago 9:8; 10:12; 13:1; rniiuding 130:17; 139:25 B:1,3, 5,8,11, :15,20;9:5, 101:4,7,20,20, 25;
23:11; 82:17; 164:1 Amsterdam 11:4
rnimost 8:16; 47:11; 5,7,8,9,14,15,17,18, 10221,22, 23; 103:4,5,
--- an 5:21;7:3, 10;9:23; 20,24; 10:1,3,4,6,7,9, 13,16,19, 24; 104:2,21,
agree 15:11; 17:25; 55:14;67:7; 119:24;
64:20; 83:25; 92:15; 10:18;14:11; 15:13; 10,11,12,16,17,19,20, 21,22, 22; 105:6,16,19, ‘
159:13;164:19; 198:15 16:12,14,16, 20; 17:2, 11;
___ 93:19 101:1O;lo2:23,23; rnione54:19;60:25;
22,25; 11:1,7,”7,13,14, 24; 106:2,10,10,11,17,
105:11;106:1; 140:11,12; 18:8;19:15; 21:2; 23:17; 16,21,25; 12:11,17,19, 22, 24; 107:2,6,11,12,
54:11;1491; 168:3; 24:3,4; 25:13,14, 17;
142:3; 144:5; 168:7, 23; 22,24; 13:9, 17; 14:2,2,4, 15,17,22, 23; 1082,5,7,
193:22 26:2,14, 16;27:9, 19;
176:15; 179:15; 181:11; 7,9,11,13,13,14, 22; 16,16, 18,24; 109:1,2,3,
188:20; 189:5; 190:25; Biong 13:20;48:5; 79:6, 29:6;33:3; 34:1; 36:9; 15:2,3,5,5,8,111,12, 12, 6,8,11,12,14,14, 16,20;
193:1; 194:4,21; 1%:12; 21;85:9, 11, 15;86:6, 14, 43:6;44:11; 47:19; 49:2, 16,21; 16:4,5,15,17,18, 110:1,1,2,4,14, 16;
197:6;200:23; 209:18 15,18, 23; 92:8; 115:15; 19; 51:16, 23; 52:4; 53:11, 24; 17:12,22,22, 23; 18:4, 111:5,10,13, 13;112:2,4,
137:18; 156:8; 175:18 14, 18; 54:1,8, 21; 55:9, 5,9,19,21, 25; 19:2,2,12, 9; 113:21,23; 114:1,4,7,
agreed 94:23; 100:16 17; 57:3; 59:10;60:7, 8;
airSSdy 5:20; 7:9, 10; 19,20, 24; 20:13, 19; 21:6, 12,13,15,22 ;115:2,6,7,
agricultural-not 65:16 24:15;48:8; 55:11;63:20; 62:8;65:12; 66:23; 67:2; 7, 19; 22:2,10, 11,16, 17; 8,14,15,17, 25; 116:1,2,
ahead 62:25; 67:1; 84:1; 102:15; 109:6; 6923; 7013; 71:25; 23:2,2,3,4,14,,15,15, 17, 3,7,10,11,12,15,20,23,
103:21; 106:10; 130:4; 153:12; 163:19; 181:5; 72:22;73:981:3, 3; 83:15, 17,21,22, 23; 2!4:3,7, 12; 23; 117:2,4,6,8,9, 18;
159:17;201:14 186:21; 191:1; 194:22; 15;84:12; 85:18; 86:4; 25:13,16,17,19,23, 24; 118:10,17, 19; 119:13,15,
AiDS 7:4; 9:9; 11:17; 202:1 87:15;89:4, 16;90:8, 10; 26:5,8,10,14,15,19, 19; 21; 120:5,17, 23; 121:7,
12:1; 23:25; 26:15; 27:18; aiso 7:7; 8:7; 920; 11:2, 91:1; 92:23; 94:14; 105:1, 27:1,3,8,9,14,19, 20; 15,17,20, 24; 122:5,13,
29:17; 34:15; 56:22; 13; 19:3; 25:15; 30:23; 4; 108:3; 115:13; 118:17, 28:8,14,14,17, 23; 29:7, 17,19, 20; 123:2,10,12,
64:10; 65:6, 16; 174:14; 31:5; 32:5, 17; 37:24; 18; 121:8,23; 122:1Q 15,16, 24; 305,6,9, 16; 13,18, 22; 124:3,3,5,10,
182:23; 188:17,21; 45:17; 55:5; 56:5; 59:15; 126:10; 128:9,10, 15; 31:2,3,9,19, 24; 32:2,6, 16,17,22, 22; 125:2, 16,
191:25;20111 65:25; 67:6; 68:17; 69:9; 132:1; 133:14, 25; 134:8; 12,24, 25; 33:10,16,19, 17; 126:5,6,9,15,20,21,
AIDS-again 56:12 77:1; 78:4; 82:15, 20; 137:9, 10; 139:12, 12; 20,24, 25; 34:4,4,9,12, 22, 25; 127:2,2,15, 24;
92:19; 94:1O,21; 105:3; 141:4,11, 23; 143:22; 15,21; 35:3, 5; 36:14, 20; 128:4,7,12,17, 24; 129:4,
ali 4:3,6,8; 5:17; 6:7;
10&5; 120:22; 124:22; 144:2,8,12,12, 14,25; 37:4; 38:8,14, X2;39:1,4, 14,16,18,20,22, 25;
7:25; 14:9; 17:25; 19:12;
24:5, 5,5; 25:25; 30:17; 12611; 134:X 137:6; 147:20,22; 148:5,24; 9,10,1940:7,17,22, 25; 1301,2,14,15,19,21,
34:21; 35:2; 36:15; 37:3; 1498; 150:9 153:23; 149:815012, 1A 153% 41:1,7,11,11,19; 42:1,7, 22; 131:4,12,14,14,18,
38:5; 40:12, 18, 22;41:12; 161:13; 167:2,~ 170:15; 155:15, 19; 161:17; 13,15,19, 20; 4i3:2,11, 22, 25; 132:3,12,14,15,
45:17, 25; 47:8,9,9, 11; 172:4; 181:2; 191:8; 163:24; 164:2Q 165:22, 12,15, 18;44:2,6,9,12, 16,23, 23; 133:1,9,15,
49:25; 51:16; 55:9; 56:15; 192:15; 195:9; 201:21; 25; 166:11, 22; 167:21,24; 14, 24;45:11, 13,20, 21; 19,22, 23; 134:2,6,12,
57:23 61:8; 62:17, 20; 202:11, 19; 205:16, 20; 168:10,12,13, 19; 169:22; 46:3, 14;47:4,4,15, 24; 12,16,18,20, 25; 135:7;
65:11; 67:17; 68:4; 70:21, 209:10 17o18 171:16; 174:3, 21; 48:1,6,10,17,21,22,23, 136:14,17,18, 18;137:1,
22;72:25;73:23; 75:11; 177:12; 180:8; 181:2Q 25, 25; 49:21; 50:6,8,9, 6,10,13, 13; 138:15;
also-i 66:11
87:2; 90:3; 91:17,20, 20; 182:16; 184:7; 186:11,16, 10, 19; 51:5,7,17,18,19, 139:7,12,14,17,18,18,
alter 105:1 20; 189:22; 190:1; 191:5,
_——-. 94:21; 100:10; 101:16; 23; 52:10; 53:2.,4; 54:6, 25; 140:11,15,19, 24;
altarnstive 33:3; 92:23; 19, 24; 194:8; 195:25; 142:7,11,12, 19; 143:1,5,
102:16, 17; 104:6,7; 21, 22; 55:4,101,19,25;
139:24; 194:16 199:13;200:4,7, 14,14, 10,15,18,18,19,19,19,
105:3;107:2; 10%14,15; 566,14,21,23, 2%57:1,
109:18;110:1,4, 19; Although 54:10; 69:20; 15, 22; 201:21; 202:14; 10; 58:2, 23; 59:6,6,7,13, 23; 144:5,13,17, 21;
113:22;119:7; 122:1,20; 78: 1;83:7; %:5; 105:20; 205:8; 210:21 13, 21,22 ;60:4, 21,23, 145:22,25; 146:6,10,16,
123:20; 124:5,7, 17; 148:19; 181:24; 184:2; Analgesk 5:2 23;61:2,3,4, 11,13,13, 21, 25; 147:19;148:1,1,6,
125:17,23; 127:2; 128:3; 188:20 analyses 23:1; 25:21, 24; 21:62:2.5.11, 14.15.20. 15,16,24, 25; 149:5,5,7,
129:17; 130:9;131:9; although-you 185:12 2622; 29:21;31:11,17; 21:63:9:9:10:15:20:21, 9,10,12,16,20,21, 25;
134:5,11, 12;138:5; always 64:16;83:22; 32:11;34:22; 35:11; 38:4; 22, 23; 64:9,10,10,12, 150:3,4,8, 16,21, 25;
Opthalmic DmW Subcommittee of the
July 22,1998 Dermatologic and OpthalmiC Drug Advisory Crete

151:8, 16,1~20;152:l, l, 01:2; 104:23; 106:18; anything 13:15; 53:16; i3:2, 15; 55:18, 19; 56:15, 136:21
.-+3, 14,17,25:153:6,6, 19:2,5,6, 13; 125:4; 56:8, 21; 60:9; 76:20; .7,18,19, 20; 59:11, 11; armamentarium 7:16;
54:17, 21, 24; 155:14, 32:10,21 ;141:4; 154:1; 92:20; 133:10; 136:25; ;1:8;62:20;63:12, 12, 19, 55:9; 148:23; 1%:1 1
i56:21, 23; 157:4,G, 60:21; 161:19; 162:5; 137:2; 202:8,12 !0,21,23, 24;64:3, 14, arms 72:18; 77:9
25; 158:4,7,18, 24; 159:4, 64:8,9; 168:10,13, 19; anyway 185:17 .4;65:10,18; 66:2;6I918,
around 4:10; 9:23; 93:4;
10; 160:2,3,4,5,11, 19; 80:2Q 183:5; 185:8; anywhere 120:3; 197:16 !1;71:5,6,7, 11, 15, 15,
8, 19,21;72:9, 17, 18; %:15, 17; 113:17, 19;
161:4,6,7, 17; 162:8,10, 91:21; 197:21; 199:3; apart 33:25; 132:15 166:22; 197:15,16
12,14,18, 20; 163:2,2, !09:5,10, 10 ‘3:16;74:15, 17, 19, 21;
apologize 84:23 ‘6:21;79:2, 15, 17,22; arte~ 52:18
12, 12,13, 14,20; 164:5, mswered 65:24; 198:12;
8,12,15,21, 24; 165:6,8, appeal 185:19; 193:25; )0:4,14,19, 24;81:4,6,8, AS 7:3, 11;8:5,9; 10:8,8;
!01:9; 205:17; 2098
16, 17; 166:3,4,7,7,8,8, 194:1,3 ),11, 13;82:6, 19;83:21, 11:15; 12:2213:11,13,
mswering 125:5; 172:19 20; 14:21; 15:15; 16:1;
12,17, 21; 167:1,7,10, appear 8:4; 87: 13;97:13 !2,23, 25;844, 18;$5:3,
mswers 14:13; 152:25; .1;86:20; 87:7;88:6, 9; 17:8;18:7,8; 20:16,16,
21, 25; 168:2,3,7,9,10, appearance 5:13; 25:13
!05:12, 13, 16 19:13,18;90:12;92:7; 18, 25; 21:6,7; 23:16, 19;
19; 169:1,1,11,17,20, appeared 88:1; 155:13,
22; 170:1,2,7,7,7,10,10, interior 42:9,10,17,19,
14
)3:8,15, 18;95:4, 20; 25:11, 12;26:2;32:6,7,
11,14, 15,15,21,22; !3;43:14; 44:8; 51:21 k5:4,6, 17;97:2,9, 24; 23;33:11, 11, 16;34:24;
application 12:17; 13:2,
171:1,7,8,17,17,20,22, mti 38:18 9:2, 3,8; 100:7,23; 35:936:5, 5;37:7, 15;
6; 71:23; 73:24,25, 25;
24; 172:5,10,14, 21; mti-CMV 104:14; ,01:19,21; 102:3;103:20; 3916; 41:11, 16,2%
89:18; 92:7; 123:12; 165:4
173:7,11, 11; 174:3,8,9, 40:15; 146:17; 161:14 .07:13,15, 16; 108:23; 42:12,14 ;44:1; 45:7,9;
applies 145:10 48:14; 49:12; 50:10;55:5;
10,14, 24; 175:1,2,6,10, .09:5, 17; 110:9, 10;
mti-glaucome 184:7 apply 23:15
12,24; 176:5,6, 17;177:1, ,11:6; 116:15,24; 117:13,59:1,5, 18;60:3,3,6,8,
Mti-inflammatory 5:2 appreciate 33:4; 14921; .9; 119:19; 120:9,24; 10;61:18; 62:13,16, 18;
2,9,13,16,17, 24;
178:22;179:6, 10,12, 15; mticipeted 162:15 192:1 ,22:2o; 124:19; 125::25, 64:16, 24;66:5;69:6,11,
180:1,4,5,12,13, 14; mticipeting 172:23; appreciative 149:11 !5;126:19,21, 24; 11!8:5,11;70:10, 25;71:5,19, 22;
181:8,14,16,17, 20; 73:3 approach 9321; 112:3; ,8; 129:9; 13u:0, 10,15, 72:7;764; 77:16,16, 25;
182:3,8, 12, 15, 17, 12, mticipetion 166:.25 180:3 !(J 132:22, -35:2; 138:23;
79:5,5,14,14, 25;8fk2, 3,
183:10;184:2,4,5,5,7,9, mtiretroviral 7:6; 18:1; approaches 166:12 .39:18,23; 140:16, 16,21;25;81:4;82:8,12, 12;
14,16,17, 20; 185:7,12, ,43:12; 145:3,4; 148:1,6,86:12, 12;87:18; 88:12,
i8:lo;93:l; 139:15; approaching 149:15
19,23,24, 25; 1869,14, !4;149:10; 151:9; 152:5, 12;89:1,4; 91:21,21;
41:8,21,22, 24; 142:11; appropriate 69:23;
‘’16,20,22, 25; 187:3,13, ,2,12,15,16,19,19,20, 92:7,8,9, 25;93:12, 12;
,80:14 126:25; 168:19 185:25;
14,18, 19,20; 188:1,1,5, !1,22; 153:5;154:lq 94:17, 17;%:5; 98:2, 2,6; ‘
~- 7,8,9,14, 23; 189:2,4, mtiretrovirais 10:25; 186:8, 14;189:18,23; 55:6, 7; 156:19;159:1, 99:21; 100:5,8, 14; 101:5;
13;19(X12191:1,2,7, 9.19 lw.20 194:23,24; 195:5;196:8; ,0; 160:4,8,10,17, 20; 102:20,20, 21; 103:1,6,6,
i, 14,20, 25; 192:1, mtisanse 14:20,23; 199:2;203:9 .61:5; 163:7,10 164:2; 15,25, 25; 104:23;106:18;
.1, 15;193:3,7,10,21; .5:15, 23; 16:2,9,12, 13; appropriately 205:19 ,70:22; 171:13,24; 107:11,12, 17; 109:3,9,
194:2,12, 18;195:7,9, 17; 48:22 approvable 13:11,11 .7218, 2Z 173:7,~ 18, 20,24; 110:21;111:11;
1%:2,4,8,9, 10,19,21, \ntivirai 4:25; 17:2,10 approval 8:21; 14:5,22; ,74:19, 24; 175:24;1“76:7;
112:12;114:10; 116:19,
25; 197:7,17, 20; 198:1,9, mtivirals 67:22 497; 89:7, 14; 191:16; 796; 180:5,12,13, 16; 24; 117:9, 11;118:3,4,12,
16,16,17,19, 22; 199:3, my 5:2Q 6:8,9, 25; 195:1; 202:25; 203:18, 18; 81:2,24, 25; 182:2, 14; 15; 120:17;121:9;123:6;
9,13,15,16, 22;20Ck7,7, [0:15, 25; 11:17; 13:19, 207:4,19 ~83:18;184:6,10, 11; 124:10,20, 20; 126:8,8;
7,9,9,11,17; 201:1,3,7, [9, 19; 14:22; 25:13; approvals 20912 [85:23;186:11,16, 21; ~27:14,14;128:3,6;
11,14, 16;203:1,6,17, !6:23; 27:2; 29:18;36:22; [87:21;188:14,18, 1’9,23; [30:15,22,22 ;131:15;
approve 204:24,24 [89:1;192:4; 193:8;
20, 23;204:11,12, 20,24; )9:23;43:16 51:17;
132:13;133:25;134:24;
205:6,7,10,10,13,17, lpproved 28:2;35:1; [94:14, 15; 195:10;1’%:1, 135:2,3; 137:10, 18;
;3:15; 57:6,7,8; 592; )6:5, 16 37:3;38:18;47:4;
19,23; 206:3,5,14,17, X112;61:5,7,22; 66:5;
[3, 14, 14; 197:25; 198:1,138:6;141:5, 16; 142:2,
18,20, 21;207:4,9; 208:2, (8:24;71:9;98:10;99:8; !, 14, 16; 199:13, 14; [5, 15,23, 24; 143:1,12,
;7:7, 22; 70:8,9; 71:16; [6722; 173:4;175:19; ~~.8, 23, 25; 201:2,3,3;
12,14,15,16, 22;209:20; ?2:9;74:2; 78:2; 79:4; 14;144:8,10, 10; 147:20;
210:1,9,10,10,11,19 181:6;187:24;203:12; ,202:13;203:12,19 148:11, 11; 152:14,20, 23;
83:8, 9; 89:24;92:4, 9 204:6, 15;206:10;210:8,
and-starting 78:23 95:7, 15;%:4; 102:1,8; 204:21, 25;205:5, 19; 153:15; 154:18;155:13,
12 206:4;207:8,12, 18; 22, 24; 156:8, 18; 157:4;
and-you’ve 103:22 105:12; 1077, 24; 108:9,
21; 111:1; 112:A 113:2;
approved-and 175:11 208:16;209:3; 210:17,18 161:1; 162:7;163:22,22;
anecdotal 163:6,10
114:14; 116:6; 126:1; approved-will 175:11 are-in 1298 164:21;165:5,23; 168:15;
anecdotalty 163:2 170:17;173:6,7; 174:11;
127:5,9, % 129:3,3, 18; approving 105:8;204:9 are-the 100:7
anesthetic 137:1 176:16177:5,9,12,13,
133:6 13&2q 137:1% approximate 151:5 are-when 93:13
angiographically 45:3 139:8; 140:24; 142:1, 1; 19; 180:11;182:11, 11,18,
approximately 17:12; ares 25:17; 81:9; 83:7 25, 25; 184:5,25; 185:3;
animal 40:4; 169:25 144:10; 156:6; 157:12; 23:24; 393, 15;42:19; 84:14; 85:9, 18;86:7, 18; 186:23;187:9; 188:15,22;
animals 66:14, 14,22; 159:14; 163:X 169:25; 54:2; 58:4; 143:23; 170:17 87:6; W.18;91:1; 95:5,7;
67:4; 172:10 170:4; 171:2, 2; 172:12, 190:14; 191:8,10, 21;
arbitrary 128:12; 132:1,6 99:15, 18; 117:7,7; 130:11 193:13,13,20, 25; 194:8,
announcerrwrt 5:11 12, 18; 173:3, 16; 174:16;
185:21; 186:18; 189:6; are 5:22; 6:13; 7:9, 10, 12; areas 65:11, 2q 69:2!0; 9,10,13, 13,21,21;
anomaly 134:13, 15 12:13, 2Q 13:12,13, 16; 81:11;83:16,25; 84:1.6, 1%:25; 197:2,11,11, 19;
190:24; 1%:24; 198:2;
another 9:24; 26:9, 11; 15:11, 25; 16:12, 18; 17, 24; 85:7 198:21,23; 199:13;200:4;
.-—-?o;61:5;76:9; 77:6; 199:20; 200:16, 21; 201:5,
23; 202:3 17:17; 18:4,12,15, 17; aren’t44:18; 64:5, 1”l; 201:6;205:8;206:11;
4; 102:5; 105:6; 19:2, 12;20:2, 12; 21:17; 123:3; 140:2 207:8,10, 10;208:4,9,23,
:10; 130:11; 139:4; any-okay 201:16
22:1, 7; 23:24; 27:20, 21; argue 95:17 23
.,1:13, 19; 152:7; 154:4, anybody 12:5;63:9, 10; 29:9, 15;31:25; 32:7; 33:2; argued 168:15 as-sitting 124:14
14, 15; 158:22; 164:21; 70:8; 113:1; 125:4; 35:13, 19; 36:4; 37:10, 15;
131:12, 14; 136:4; 179:16; arise 131:5; 198:23 aS-WSll 203:18
166:3; 184:22; 190:9 38:5, 6; 397,8,8; 40:23;
202:8; 204:3 arithmetically 160:].4 ascertainment 176:6
answer 7:25; 57:8; 59:10, 42:6, 21; 45:8,19, 2C$
14;62:8; 66:1; 74:22; 77:7; anybody-would 179:14 46:3; 50:13,14,15,15,16, arm 9:23; 27:19; 28:8,9, Asia 132:16
81:2:93:23:99:11.11: anymore 195:25 18,19,20, 20; 51:4, 20; 22, 25; 31:6, 7; 105:4; Asians 69:10; 134:5,11
. . .. . . >/.
Opthalmic Drug8 Subcommktee of the
D&matologic and Optkdmic Drug Advisory Crete July 22, 1998

hide 183:7 55:8,9, 10;67:3, 19;70:5; 48:23;64:13; 71:11; baselines 138:13 be-the 195:11
.—-=
ask6:7; 11:22;24:21; 71:8;72:12,23; 73:11; 140:22; 142:17; 162:11; basic 23:14; :132:3;189:6 be-there 70:6
53:4;56:1;57:5, 13;68:12; 74:7,8, 12;75:1; 76:6,12, 166:14;204:15 basically 108:19; 153:17; beer 73:3
69:24;70:1;75:18; 84:10; 14,14, 2Q 77:4, 12;78:20, average 51:23;61:1; 181:17; 1%:12; 198:1; became 62:14; 115:17;
104:21;105:15; 123:21; 20;80:9, 9; 81:4,6,9,20, 197:12,19 204:7 116:10, 23; 118:10;
127:18;139:6; 148:15; 24;82:1,2,4,5,7, 25; avoid 203:23 basis 17:15; 50:5; 64:6; 142:17,24; 158:6
149:24;155:5; 182:21; 53:12, 13;84:14; 85:7, 8; 108:7; 109:25; 165:14;
aware 5:22; 1921; 33:2; because 4:8; 11:12; 13:2;
198:16;202:19 68:20;9(k14, 17,20, 22; 168:12; 187:25
71:14; 114:20; 117:16; 19:3;41:19; 47:8; 62:16;
asked 62:9;71:2o;%: 18; 91:5,7,9,13,17, 19;92:4,
120:23; 191:24; 1%:1 be 5:24; 6:1,31;7:16; 8:4, 64:5; 66:25; 68:20; 69:9;
104:21;10614; 183:12; 6,18, 19,21 ;94:21; %:10,
away 23:20 64:23; 75:2; 5; 10:7; 12:18, 18; 13:16, 72:9,9, 15;73:6; 74:23;
184:1;191:13;202:20 15;97:15; 102:1, 15;
199:10 18; 14:14, 19; 15:6,10, 19; 75:9, 13;77:8,14, 21;
103:2, 23; 104:7; 105:3; 16:22; 17:6; 19:1, 23;
asking 57:25 99:25; AzT 199:21 78:8; 79:1, 16;80:6,19,
106:4,7; 107:8, 25; 108:5, 21:25; 22:3, 14; 23:5,17,
127:24 23; 83:1, 8; 85:10; 86:2,
18; 109:5, 18; 1101, 3,4; 20; 24:11; 26:19; 29:18;
aspect 149:16; 184:15 111:8; 113:22; 114:5,7; 25;88:16; 89:3; 90:20;
aspects 184:24; 191:23 117:2,17, 17; 119:2,8,9;
B 33:11; 34:24; 36:1o; 37:6, 93:2,15, 20; 97:8; 98:18;
20;39:l~40:ll, 13, 16; 103:14; 104:3; 106:21;
assess 54:12; 139:23; 121:14; 126:23; 128:5; 42:4, 8; 43:17; 44:15, 22;
166:14 129:5, 17; 131:2; 132:23; B 33:16; 34:3, 12;35:9,9, 108:13;115:24; 117:11,
45:18; 46:6,10, 13;47:7,
133:15,22; 134:2,20, 23; 25; 38:8, 17;42:7, 24; 19122:5,15, 17; 123:25;
assessed 169:18 12;48:13, 17;49:2, 16;
135:7; 137:7; 138:8; 46:17; 47:14; 48:2; 49:1,2, 124:14,21; 126:4; 127:24;
assessing 95:15 51:15; 52:6,9, 24;54:1;
139:23; 140:1,21; 141:16; 25; 51:3; 55:16;78:14, 16; 128:19; 129:24; 130:21;
assessment 22:11; 24:6; 58:17, 25; 61:4, 7;62:23;
142:3,7,13,16, 18,21; 80:4; 160:5,7; 161:1,2; 63:7,19645,7, 14;65:5; 132:2; 133:7; 134:24;
25:9; 101:20 109:4; 138:10; 143:12; 147:25;
143:3,22,23, 24; 144:1,2, 195:7 67:1; 68:7, 20; 69:24; 70:9,
110:11, 17;111:14; 150:5; 151:14; 152:16;
121:15; 171:25; 174:23; 3,7,9; 145:1,5, 17; 146:2, back 9:16; 10:14,20; 10,25 ;71:9, 10,12, 14;
4,19, 24; 147:4, 20; 148:4, 15:24;23:21; 50:5; 54:20; 72:4, 19;73:4, 14;75:7; 155:20; 161:24; 162:7;
175:4 166:18; 168:10,13, 16;
5; 150:2,3,7,16, 19; 57:5;79:20; 84:25; 85:25; 77:7, 24; 78:9; 791; 81:8,
assessments 40:23; 151:20, 25; 152:5,9,9, 18; 171:9 176:2?; 179:21,21,
86:3,19, 22; 87:3, lQ 10,18, 23; 82:6 83:16;
108:20; 153:7 154:5,15,16,19,20,21, 23; 182:1, 17; 184:22;
94:19, 21;99:25; 100:1, 84:12,18,18, 21; 85:7,8,
assigned 26:24; 27:2; 23,24, 24; 155:24; 156:13, 14;114:13; 119:9, 11; 10, 15;86:10; 87:13; 18617, 19,21; 187:17;
,,
79:21 22; 158:22; 162:17; 121:4;142:21;143:18,23; 88:13,23 ;89:1,6,7,8,15; 1895; 190:15;191:10
assignment 113:19; 163:14,18, 19; 165:20; 145:7;157:3;169:9; 9015, 19;92:25; 94:7, 14; 1%:22; 19923, 24; ~
_—- 121:7 200:24;203:2; 206:9,15
166:2; 167:11; 168:24; 170:2,7; 180:6,6; 199:16; 97:7,15,21, 25; 98:6,12,
assignments 76: 12; 169:10,17,23, 25; 1707, 200:9,9,9; 204:2;206:20 18;99:20; 10Cl:~101:22, becaus-in 144:14
113:9; 114:7 12,13, 17,21,21; 171:1, backbone 17:5 25; 102:1,5, 15;103:15; become 76:5; 120:17
Assistance 200:2 6,6,17, 21,21; 172:8; background 134:3 104:6, 15; 1051:4,6; becomes 117:10; 188:24
173:11; 174:3; 177:6; 107:12; 10915; 115:3, 13;
assisted 113:25 backgrounds 68:19 becoming 19:1o
181:15; 183:2,17, 24; 117:10;119:1,8,9,14, 24;
Associate 6:18; 12:2 184:4;188:9; 1899, 10; backwards 199:10 120:5,6, 10;121:25; been 7:3,4 ;ll:l,2,4;
associated 23:5; 25:19; 192:15;193:13; 195:23; balance 22:14; 69:5, 6; 122:16,21; 11!4:4,5,9,20, 12:17; 13:7, 14; 14:21;
78:9; 106:25; 169:16 1%:10, 10; 197:15, 19; 134:13;139:11 23;125:2,3,3, 6; 126:6; 18:13,16, 24; 19:1,22;
assume 39:18; 92:18; 199:11,16, 17;201:7; 129:22,23; 130:9; 131:1, 22:1,23, 25; 23:1, 22;
barely 136:25
120:13;150:5 202:15203:7,12, 13; 13,14, 15; 13:2:10;133:6, 24:15; 25:6; 26:14; 33:3;
bars %:17 34:7; 35:2, 6; 39:1; 40:21;
assumed 84:15 208:12;209:12,25 B;139:16;140:15; 142:13,
base 16:11, 15;93:16 45:11; 53:7, 10;60:17;
assuming 202:23 Wteck 185:3,4 14; 146:16,19, 19; 147:2,
Based 5:15;25:22; 26:1, 16,16, 23; 148:3,23; 65:20,21 ;73:12; 76:3,6;
assumption 93: 14; Wtempt 15:1; 105:1; 3;27:20;28:13, 15;29:6 84:3; 88:4; 91:18; 92:22;
142:6; 144:14; 166:22; 1491; 150:17, 23; 151:6;
178:22 33:18;40:23; 48:25; 93:9; 94:23; 98:10, 18;
171:16 153:4; 155:14, 19; 156:25;
assurance 49:15; 67:10 49:15;51:12;53:12;54:4; 157:4;158:5,7, 23; 101:23; 102:22; 104:21;
assure 44:17; 54:22; attempted 7:25 57:2;&120;72:14;74:12, 107:7,8,9; 109:12;
160:18; 161:24;162:4,6,
168:14; 199:14, 17; 200:6 attempting 107 18; 14,21 ;7922;8019; 6,10,18,20 :163:8;164:4, 11020111:7,19, 20;
at 5:14, 19;6:19; 7:10, 12; 141:23 8911,21;91:2094:7,7; 16,21; 166:11, 13; 169:5; 114:15,16; 115:12;
10:3; 11:1,25; 13:6,10, attend 7:2 95:18, 24;%:25; 97:19; 171:13; 173:12,21,22, 25; 120:22; 123:5,7,22, 23;
attention 27:12;31:8 100:16;117:23; 127:19 174:%175:11,12, 18; 125:18, 23; 126:5, 23;
19; 14:16, 24; 16:2; 17:4,
13,15,23, 24; 18:22; 19:3; 137:17; 188:4 141:12; 168:25;171:10; 177:7; 180:Icl 17,19, 22; 128:1,20; 130:17; 131:16;
21:5,6,21 ;22:16; 24:5,6, 179:16;1$0:3;183:14; 181:23;182:3,6,9,13, 25; 134:24; 137:6; 140:13, 25;
attention-the 41:23 184:7; 187:5;193:17; 141:4; 149:12, 17,20;
16,16, 24; 25:12,15, 20; attenuation 146:12 183:3,10, 13; 184:8.12.
26:9, 25; 27:5,7,8,8, 22;
204:13;20922 18,22,24, 25; 186:23; ‘ 162:9,23, 25; 163:8;
attract”we 141:11; 194:18 baseline 26:25; 27:3, tX 1871,13, 13; 189:14; 164:12; 165:8, 12; 172:11;
28:3,7; 29:9, 10; 30:7,7,
attributable 41:15,20 29:9, 10;31:11, 12,18,18, 190:1,5,6,8,12,14, 24; 176:1,10,12,15, 18;
23, 23; 31:2,3, 23; 35:23;
47:18; 117:13 21, 23; 32:14; 33:1; 34:13; 191:2,6,8,9, 17; 192:12, 177:2; 179:22; 180:6;
36:17,19,21,21, 25; 38:4;
attribute 88:10 36:21; 37:10,12, 13; 14, 22; 193:2,,4,5,7,22, 182:13; 183:24; 184:4, 20;
39:10, 13;40:7,15,15,17,
40:25; 42:21; 43:8; 50:14; 23; 194:4,13,,14,16,18, 187:3,5,8, 12; 190:3,15,
— 22,25, 25; 41:7; 42:6,23, attributed 40:13; 120:10
51:5, 24; 73:5; 82:22; 19,22; 195:5,11,14, 15; 19; 191:1, 13; 194:10, 22;
23, 24;43:8; 44:8, 11; audienca 177:1; 181:16
83:14; 85:18; 90:17, 22; 1%:7, 20, 23; 197:3; 198:9, 11;201:1,9; 204:4;
45:14,15,16, 18;46:11, 184:6
11, 13, 17, 18;47:2, 10; 91:10; 92:4; 109:20; 198:19,24; 1’99:2,12,20, 206:10; 208:8,11, 21,25;
authority 26:14 114:1; 115:15; 118:11; 209:20,20
49:13, 17;50:6,6,14,15, 24; 200:12;201:4,12, 20;
19, 19,24, 25; 51:5,5,8, automated 46:15 137:24; 138:8, 16; 142:7, 203:2,4,6,1:2,16,18, 19, been-for 198:11
19,20,23, 24; 53:7, 9; autopsy 131:2 8; 143:24; 144:25; 145:1, 19;204:2,6, ‘7,14;205:1, bafore 15:16;49:9; o
54:6; 55:14, 15; 56:1, 4,5; available 10:10; 12:20; 4,7, 18; 147:9; 153:8; 4,9,17,20, 25; 206:2,3, 70:25; 75:13, 14, 19;
59:18, 23; 60:2, 23; 61:2, 15:4; 17:18; 19:12;20:21; 154:24; 163:18 17;207:5,6; :208:14; 76:19; 78:3; 80:7; 84: 17;
18;62:13, 17, 21;64:9; 21:9; 22:10; 35:1; 38:6; baseline-is 92:18 209:25;210:22 87:17:99:22:104:25:
,---
. ...* — . .. —- ————.—— ..9— .* a-—s-Aa. l-c> A.l. a.. L-c-..
Opthalmic Drugs Subcommittee of the
Tlllv 22. 199s Dermatologic and Opthah@c Drug Advieory Crete

i14:6,
13;1H21; 126:12; 03:17 4, 19,21; 32:23; 36:11, 41:8; 142:3,14, 20; ame 13:7;26:5; 47:10;
-~a; 132:18;137:3; ~ 2; 37:19;83:20, 23; 84:2, 43:16; 145:12; 146:1,11, 1:24; 141:18; 143:18;
,etweerr 12:16; 28:8; ~
i, 10; 152:8;153:9, 9:16, 20; 33:15; 34:12, ,14,16, 19;86:7,9,15, 9; 147:3,9, 16; 148:4; 45:15; 157:25; 168:11,
68:11,13, 16;170:3; 8, 20; 37:21; 52:7; 62:10 7;95:2; 115:24; 117:6, 49:21; 150:7, 19; 151:8; 3
.19; 173:18;175:7; 6:13,14, 15;75:25; 1,14, 17,20; 118:21,24; 52:4;153:21;154:1; an 4:9; 9:7; 13:12; 17:25;
179:13;182:22;183:23; 8:14; 794, 12;84:5; 20:4,18, 23; 122:15; 56:2Q 157:16, 17; 158:9, 8:9; 26:19; 31:25; 32:6,
185:6;187:12;190:20 0:10; 93:5, 18;94:2, 15; 29:11; 1307,13,23, 24; 3; 159:24; 160:11, 19; 9;35:9;42:15; 45:6;
begin 8:15, 16;14:17; 9:7, 10; 100:20; 101:19; 31:8; 132:1, 1; 171:18 61:13; 162:11; 163:9; 7:17; 54:22; 57:8; 58:20;
113:5;160:10;175:23 02:13,14, 19; 103:9; lorders83:21;91:2; 64:4,9; 165:19; 167:3,4; 9:25; 60:1; 63:9, 10;66:8,
05:19,21; 106:2; 110:17; 20:2; 131:19 68:14, 19; 170:3; 171:5, 0;695; 70:1, 11;72:2;
beginning 14:24; 18:15;
12:1; 115:1; 117:7, 18; lorrowed 9:22 ; 172:2,6; 173:6,14, 23; 3:6; 75:3; 78:1O;81:15;
22:24;69:16, 17;90:21;
19:15; 125:9; 127:12; 76:8,17, 22; 177:24; 4:7, 12; 85:15; 86:6,8,
100:17; 106:7; 107:9; )oth 10:6; 14:6; 15:11;
28:10; 130:8; 132:14; 78:9, 15; 180:10,20; 9, 20; 87:8,10, 25; 89:2,
135:6;140:18; 142:18,22; !0.1~32:l ;41:6; 44:22;
33:6; 156:19; 160:3, 5; 81:13, 17; 183:12; 4; 93:11; 94:24; 97:7, 21;
163:4,8 ;2:14;69:7, 11;72:16;
62:20; 174:25; 197:17, 84:17; 189:10;190:4; 9:21; 102:4, 15; 103:15;
behatf6:17; 101:4 ‘6:25;78;6;82:2;88:7; 91:19,24; 192:2,11, 16;
!0 ,00:25; 108:23;lll:lQ 12:24; 115:1; 116:5;
behaved 97:3 93:8,21, 22; 195:15,20, 17:10; 119:4; 120:10;
)etween-unevaluable .24:24; 126:8;133:19;
behaving 155:15 )4:6 5; 197:1,3, 17;198:21; 22:16; 124:5, 25; 125:2,
.34:1; 139:18;158:19; 99:10,14, 21; 201:1;
being 4:8; 11:7; 13:5; .593; 179:11,15,17; ; 127:18; 130:5; 132:14;
mtween-within 102:9 03:15, 24; 204:9;206:3,
18:13, 15; 23:23; 25:1O, .80:24; 1894; 203:5 34:11; 136:25; 138:21;
12;30:21;45:7, 12;46:24; }eyond 54:6; 131:11 6; 208:21, 24; 2092,10, 39:3,13,16, 22; 140:15;
47:14;48:21, 24; 57:23; )iWJ100:12; 125:10; )oth-tha 126:7 1;210:11,23 43:9,11,13, 14; 145:7;
60:22;67:23;75:2,5, 11; .76:6 )ottom 17:24 lut-et 142:13 46:11, 22; 147:4,9;
78:14, 16;79:25; 82:23; )ig 44:18; 45:24; 46:20; #outs 913 IUtt 136:22 48:11; 152:14; 153:1;
87:4, 18;98:5; 104:25; ii:ll; 66:4;82:6; 103:8;
116:18;136:25; 140:16,
)OX205:2 ,y
6,17;
,;.
7:5;
K.
9:3, 54:19 160:9; 161:19;
c

,09:22; 126:4; 146:7;
24; 141:7;142:24; 149:13;
)OXSS39:2; 50:18;76:15 ,14;
11:13;
14:14;16:5; 64:5,10, 17; 166:1 “
69:lq 173:14; 174:+1;
169:5;210:22 mek 69:24; 70:12; 1:1;22:15;
25:11
;26:8; 83:13, 14;186:22; 187:6;
162:15; 165:25;167:8; lig-not 172:1
, 477:15; 179:4;189:12; [35:7; 20(k13; 201:18 7:10;
32:23;
39:1;
40:5; 90:18,20, 21; 191:8;
193:16;201:6;202:20; Jigger 18:22; 12912; >rief 22:4;67:18 1:3,16,
25;
44:2;
45: 16; 93:8; 198:15; 199:14,17,
188:19 ,
203:8;206:15 ]riefly 15:9, 17; 1764; 6:2,
3;49:3;
55:6;
6010; !0;200:6, lx 201:12, 19,
#—-%f166:15; 180:21 >iggest 78:5 184:23 ~l:20;
62:18;
63:19; !4;203:17, 22;204:24;
Sileteral 62:11,19 >rilliant 124:5
8:16;
69:15;
72:25; !05:2;207:24;208:15;
eve 6:1;7:14, 19;8:2; ‘6:21;
81:3,9,
16;87:17; !10:7
157:21,23,24; 158:5, 18;
7; 20:12,13, 23; wing 100:1;204:10 0:4,
8;94:25;
98:25;
.1;35:21;36:6;42:15; 159:2,2,7
oileterai-you 157:22
Bristol 167:12 02:1;
107:11,25;108:6, :an’t 39:17; 56:20;%:1;
49:2;53:10;54:13;57:2, 2; woader 19!):17 8,23,
24;109:1,3,15, 01:1; 103:16;125:2,3;
59:14,25; 63:18;64:3; Jill 20:23 31:18; 136:18; 144:18;
woken 187:13 6,18,
24;1102, lT
66:17,24 ;68:8;81:1; 82:1; ~ind 15:19, 20; 16:2,4,9, 11:1,8,9,10,12,15,19, .648; 177:7;206:3;
brought 36:10;37:20;
87:25;88:4, 25;89:5,12, 15
101:23;129:2; 191:17 !0;
113:24;
116:19,20,24; !09:21,24
15;94:4;95:7;97:2, 3; binding 16:6, IO, 14 205,6124:9; 129:2,14,>ancer 56:6
102:9;106:3;111:21; bump 143:18 :annot 13:14;79:3,22;
biologics 188:7 ,4;
131:22;
133:12,24;
126:9;128:18,19; 132:1O, bunch 208:7 .34:24;
139:10;146:9; [19:15; 145:5; 180:14;
16;134:14,16,24, 25; BIRNKRANT 4:24,24
burden ?06:8, 12 ,47:2;
149:4,18;151:4; [84:14; 186:13,16, 17;
139:12;147:3;154:25; bit58:20;74:16; 79:6
80:24;84:7; 86:1,1,9; business 15:25 159:5,
11,11;163:21; L87:3,9
160:20;161:8,12, 17; [65:1Q
175:11,12;1“78:1;:apable 63:11; 64:4;
172:13;184:21;186:8; 88:5; 113:2;126:6;160:9; But 13:8, 13; 18:24;
162:13;163:19,25; 27:23; 31:3; 32:1; 34:16, 181:25;
184:8;186:3; )7:12; 122:6; 174:16,17
191:20 187:14;
194:2,
15;204:4; :apacity 167:20
181:13, 15; 194:8;203:16 25; 37:6, 24; 39:4; 40:18;
belong 126:20,21 Z05:4,
7,7;206:2,3;~w:1 :apture 73:2; 180:11
black 69:7 41:20; 43:16; 44:2; 45:8;
below 51:6; 143:25 46:16; 48:9; 53:18; 54:22;
blacks 69:8134:7,12 :are 23:21,21; 65:3,4;
Ben 6:18 55:7; 56:1; 58:15, 17;
blanks 207:5 c X:4; 118:3; 146:9; 149:7;
benefii 20:10;703; 93:6; 60:20; 62:4, 18;63:16; 174:14; 189:21,23; 192:1;
162:17 blind 177:11 64:4,10,15, 17;65:17,20 199:25;205:6, 25; 210:17
benefiied 7:8; 89:18; blinded nl, 2, 3; 90:6 67:1,22, 22; 70:2, 8; Calculated 35:21; 3%1;
58:16 cared 104:3
144:11; 162:7 blockers 43:14; 48:11 71:13,16,21, 21;72:9, 18;
73:3,15, 16;74:19, 23; cakuletion 133:4 careful 173:9
Benzomitizols 167:14 blood 186:18
75:11;77:3, 21; 78:4; 79:2 California-San 4:231 carefully 45:16; 62:13;
besides 189:8 blow 208:15 16;80:2, 19;82:12; 84:11, 65:9; 173:14
call 74:18; 82:7; 83:11;
best 8:1; 56:23,24,24, blown 9:9 24;85:9,10,14, 23;86:21; caregivers 6:23
84:3,5, 11;85:12; 86:16;
25; 57:8;61:17; 68:16; blue 50:20; 51:7;75:12; 87:15; 88:6, 19;89:13, 21; 91:4;94:23, 25; 11025; carried 76:4; 77:10;
154:11; 161:19; 162:19; 78:1; 156:19 91:8, 12;92:15, 16;93:3, 111:15;112:9; 120:14 164:13
173:14;186:14; 205:11 Board 6:5; 10:18;22:21, 20;%:19; 97:l& 98:12,
..— . called 74:24; 85:10; carries 148:20
a43:13;48:ll 25; 165:13; 167:3; 168:9; 19,25;99:17; 100:5;
86:10; 117:3; 127:20,20, car~ 192:23;209:15
.ter 28:16; 33:21; 169:17 103:8; 109:10;112:6,21;
23; 128:2, 24; 129:131,14, case 16:17;45:24; 63:4;
J3;49:1; 50:14,17,20, Bob 5:4 113:16;114:6, 18;115:7,
23; 118:9;119:8 120:2; 14; 184:11 67:7; 81:5;89:19; 102:22;
/1:1,6,8,9; 74:18; body 18:18; 178:21, 24;
bL:16;86:9;87:5; 104:18; 121:16122:5, 23; 123:24; calling 74:25; 75: 1; 103:7 108:20,21; 109:1,2, 24;
181:25; 182:4 calls 74:17,20, 22; 81:21 110:13, 17,23,24, 25;
105:9;122:1;123:22,24; 124:6,21; 126:18,25;
153:24;154:18,22, 24; bone 10:6; 20:3 128:5,21; 129:6,21; 84:12;85:15; 86:13, 14; 111:13;112:9; 140:24;
155:3,23; 156:6,22, 23; booklet 59:7 131:4,6, 10; 133:14; 94:18; 100:24, 24; 11!7:14 159:6;167:1;
—.—— 175:6;
190:20;191:8;201:20; border 21:1; 26:2; 30:12, 134:5; 138:1O;139:12, 19; I 129:23 I 179:7:186:20
Opthalmic Drugs Subeommitiee of the
Dermatologic and Optha.hdc Drug Advisory Crete July 22, 1998

cases 54:1, 25; 56:7, 11; 74:25 16,
22;197:9,
14;202:19, 136:13; 148:18 clinicians 42:13;45:16;
68:15;74:25, 25;78:7;
_———._ >ntral 69:9; 88:18; 23;
203:25;
204:1 Ciba7:l; 173:12 120:6; 173:21, 22; 177:8;
79:15;81:7,9, 11, 18; [95:7 Chambers-these 134:9 Cidofovir 8:5; 35:6; 74:1; 189:11; 1%:1
83:5,22, 23;85:10; 86:9; :ertain 18:8; 47:15; shance 54:19; 106:8 ?8:14,15, 25; 99:2; clinics 137:7
87:13;95:1;97:7;98:1; 114:11;115:24; 139:24; 102:12;123:13; 125:22; close 75:23; 166:4;
chandler 14:11, 14;
100:24;102:23,24; 1W:9; 146:11; 160:22; 188:12; 15:10,13;21:12;22:3,15, 126:7,19; 163:16,20; 167:4; 181:16
115:12;116:9; 117:22; 192:4;202:18 15,23; 23:7, 8; 24:20, 22; 167:25;168:11; 183:1; Eloseat 175:5
163:7;175:4;184:21; ;ertainty 7:20 37:6; 25:2;57:15,16,17, 21; 186:19
188:25 due76:17
;3:6; 99:17; 112:22; 58:1,13,16, 1259:4, 20; :ircumetance98:17 duster 32:1
cases-and 83:4 [15:7; 123:23; 131:16; 50:19;61:1o; 63:14, 18; circumstances 77:22 CMV7:12, 15,21, 22;8:3,
Ca~ract 43:20, 22; [4012,25; 141:6; 155:18; 54:2065 :2;66:1,8, 17, :itiee64:ll f,20; $z12,18; 12:19;
52:11,13 L73:5;174:17, 18; 180:13; 21;67:15; 68:1; 132:10;
[83:11; 186:1;198:21; claim 53:15;61:5; 14:6; 15:3,6; 16:23,24;
catch 198:22; 199:6; 134:18;149:4; 152:14;
Zol:ll,20; 204:2,4 160:19;169:15 17:22; 18:7,23, 25; 19:8,
201:21 153:7;154:4,9,12, 15;
:Iaims 22:12 ?;20:13; 21:18; 25:9,17,
catch-up 8:16 :erteinty 179:25 155:6,7,12,18, 24; 156:1,
dar~ 113:20; 118:18; 18;26:14; 27:18, 20; 28:5,
categories 108:16; :haired 22:19 16;157:2,7,9,19, 24;
137:23;186:24 10;29:3, 16; 30:8, 24;
151:23 2HAIRMAN 4:2, 19; 5:8; 158:2,11,20
31:14;32:21;33:8; 34:9,
;:12; 8:25; 11:20; 12:5,8; chandler’s 91:12 Aass 16:13; :148:22
categorized 58:25 15;35:24; 37:16; 38:14,
[3:21; 22:16, 21; 23:20 Chang 6:18 dassk 21:141 17,19; 41:5; 45:22; 49:21;
category 69:11; 209:7
i7:ll, 19; 59:2; 61:23; ;hange 78:11; 88:14; :Iassifiable ‘109:16; 50:22;53:13, 17; 54:17,
catheter 20:5; 186:17
;9:23; 70: 16;89:25; 13913; 141:25; 144:4, 10; 110:21 24;55:8, 13; 56:7, 11;
Caucasian 697 )1:25; 93:24; 95:10; 99:5, 163:24;164:2; 165:15; Aassifketio[n 106:23 57:4;65:17; 68:2, 3; 69:13;
caught 208:13 ?3;101:11, 14; 103:11; 169:2,7; 170:23; 178:10, 70:7;74:2; 82:13;83:21,
:Iassified 92:25; 109:2,
caustdity 24:5; 40:12; [04:12; 105:12, 15; 106:6; 16;198:8 24;84:14,15; 86:14;
), 15, 1Q,24; 110:1,4;
47:9 ‘ - 16 [ 12:16,24; 113:4; 118:7; 37:13;88:17, 17;95:16,
:hanged 86:1; 140:5; 116:24
[19:4; 121:2, 22; 124:19; 21,22; 97:1,5, 22; 99:8,
causative 16:1 141:13,17; 145:23; :Iassify 155:10
[25:14; 126:13; 127:3,5, 14; 125:17,21; 131:17;
cause 116:21; 124:22 168:24 :Ieen 59:25; (51:14
1;129:1; 1304; 131:10, 139:15, 19; 143:22;
,. caused 30:12 ?3;132:7; 135:6; 136:3,7, :hanges 30:15; 45:1; :Ieaner 63:5
f6:19; 52:10, 11;67:7; 144:11; 145:14; 148:24;
causes 54:24 Ll; 137:14, 16; 138:25; :Ieer 13:4;61:3;62:14; 157:17; 158:6; 162:14,21; “
[39:5; 147:5, 12; 148:12; 32:10;86:8;88:4, 12;98:8;
__a causing 178:23 79:17;83:23; 84:20; %:7; 163:4,7, 11;164:5,7;
[54:7; 157:12; 159:5,14, 144:24;145:2,4; 171:19;
cautionary 203:24 190:4;191:4;1%:22 )7:15, 15; 13C~:6,13; 165:24;166:17;167:12;
[7; 162:4; 164:11; 165:1; 146:18;157:15; 192:8; 174:9,11,15, 23; 176:2;
caveats 53:23 :hanges-and 177:16
[67:5; 168:22; 172:18; 206:13;208:19 178:5,12,19, 20; 179:10;
CD2 140:14 173:16,24; 175:21; :hanging 79:24; 148:1 dear+mt 83:22 181:24;184:3;185:4;
CD4 29:19; 31:9,18,18, 176:11,14,19, 25; 177:21; :harscterlstk 97:7 187:25;191:4; 192:12;
21, 23; 32:6,8,14, 17; 178:4,10, 16; 1793, 13; deerance 4c~3
:harecteristics 15:8; dearer 86:2C);123:22
195:22,24; 1%:4; 202:14,
33:1; 34:18; 36:19,21; 180:19;181:7, 10; 182:20; 16;210:14,18,21
29:9;34:13; 37:10, 12;
37:3, 10;38:1; 60:3; 92:19; 183:8;185:5, 15; 188:3, deerty61:ll;62:17, 18;
41:22;94:8 CMV-that 163:7
93:2, 3,5; 139:18; 140:5; 11;190:11; 191:12; 192:7, 53:13, 16;66:21; 68:6;
142:15,17,19,21, 23; characterization 114:25 90:20;87:13;88:7, 13; COHEN 4:11,11 ;61:23,
20,25; 193:14; 195:1, 3;
143:1,4,9,10,15,18,20, 1%:6; 197:5, 23; 198:1,5, ~haracterize 89:5 B9:17,18;%:5; 128:13; 24; 62:25; 63:8; 64:8, 24;
23. 25; 144:4,11,17, 18; 13;200:19, 23; 202:2,4,6, characterized 88:4 133:2; 134:15; 146:15; 65:23;(%7, 10, 20; ~7:11,
145:3,4,11,12,15, 18; 3,11, 22; 203:14; 207:2,7, 163:9; 169:9; 174:11; 18;68:17, 23;69:1, 22;
charged 193:16
146:4,6,7, 25; 148:10; 18,21, 23; 209:4, 17; 183:17 101:11, 13;103:11, 12;
chart 194:9 104:8, 11; 121:22,23;
195:17 2103,5,25 clearly-clearly 182:14
checking 115:9 122:23; 123:20124:1,12,
cells 17:12;37:3, 5; Chairman’s 112:21 clinic 137:6
172:7;186:18 chemkal 14:21; 16:13 25; 125:12; 172:20,21;
challenge 46:16; 174:13 clinical 6:6; 1,1:25;14:12, 173:1,2; 174:7; 177:2,21,
censor 35:19; 81:23; chemist 11:13
challenging 23:17 19; 15:9; 21:13; 22:4; 22; 178:6,14, 17,25;
82:25; 91:7; 103:15; chemistry 71:6; 88:23
Chalmers 179:5 23:13, 14; 24:8; 25:12,15, 188:3,4; 190:11, 12;
109:1;119:9 CHEW 4:17, 17; 101:13, 23; 26:1,3; 27:10; 28:15, 191:7; 198:5,7; 210:7
chamber 42:9, 17;43:14 14, 15; 157:14,20; 158:1,
censored 75:3, 14;76:6 22; 3013; 33:19; 41:3;
CHAMBERS 5:1, 1; 12:9, Cohen’s 184:10
78:3; 83:13, 17; 109:25; 9, 12; 176:14, 15; 182:20, 44:21; 45:4; 49:7; 52:21;
110:3; 139:23; 143:17; 10;7016, la 75:18,20, 21; 183:7, 21; 184:19; cohort 23:24; 162:25;
54:4, 11; 56:13;61:7; 63:5; 170:10,10, 22; 171:3
191:8,11 23;76:9,14,23, 25; 90:1, 193:1; 1%:17, 18; 197:6; 64:12, 17;68:14; 70:19;
5,14; 91:15,17; 92:1,6 l%tl; 202:2,3; 209:17,18 71:14;74:19,21;81:13; cohorts 140:16; 146:17
censored-was 109:25
93:1o;94:4, 16;%:5,9, Chew’s 198:14 84:4; 89:6; 93:6; 94:8; colitis 210:22
censoring 81:17, 17; 14;97:2, 23; 98:22; 99:13,
82:5; 103:13 Chicago 10:14; I37:1o; 95:25; 108:6,6,9, 1~ colleague 26:9
21, 24; 100:4, 13; 101:10; 109:3; 111:14; 112:8,10
Center 4:16; 5:17; 25:11; 148:18 colleagues 149:5
102:7; 103:17; 104:10,20; 125:1; 130:22!;132:13;
45:17; 56:6; 107:4; 108:1, 105:11; 106:1,12,21; chief 14:9 collect 139:21; 190:25
2,11, 18,20;110:11, 15; chime 204:18
163:12, 16;164:7,24;
.— . 107:17,21; 108:3; 109:3, 167:18,20, 23; 169:12; cokctad 138:2; 146:17
111:2,5,9, 12,16; 112:11, 6,10,15, 18; 110:18; choice 184:25; 185:1 collection 11:5; 131:5;
17;113:8,22; 117:2, 12; 171:22; 174:;!3;175:6,14,
111:10; 112:2;114:9, 25; choose 104:22; 167:23, 16; 177:11, 1!2;178:8; 194:24; 200:24; 201:11
119:17;120:5; 123:15; 116:16, 19; 117:22; 23, 24; 191:19;209:16 College 4:13
130:16,16, 17; 131:12; 179:1; 183:7; 189:10
121:24; 122:7; 125:17,20; chose 10:11; 141:10, 12
175:6,8,9,16 126:15,16,21, 24; 127:11, clinically 21:X 62:6 color 46:7
centers 64:12, 17; 19; 128:3, 17; 129:7; chosen 36:20 clinician 119:17; 173:20, column 108:17; 109:4
101:22; 123:3; 127:13; 131:14,19, 24; 165:2,5; Chris 4:22 24; 175:12, 1:3;198:4 combination 18:2;
161:7; 166:20;167:18; 174:11; 178:19; 183:6,16, Christopher 9:1, 1,2; clinician’s 175:1.4 124:24; 143:3; 165:10

Mill- Rr=nnrtlno Cnmfmnw Tnr me:n.11..sc+nim (Vl “.8.-. . ..-kl-.43----
Opthalmic DIWS Subcotitiee of the
July 22, 1998 Dermatologic and OpthdItic Drug Advkory Crete

combinations 140:15 190:1;195:17;209:21 [:18;72:5;80:3; 177:11; mtext 13:17;17:22; ;8:17; 60:18;68:5, 7, 20;
)1:17; 209:20 S:2;55:12;95:25; 127:1; 75:6,18;83:1,3,11, 14;
c--”=bine 133:7; 198:15 :ompares 21:20
57:9;187:6; 189:18,20, 34:23;9020,22;91:1,7;
>ined 52:3; 132:19 73:10; inducting 11:16
33:7;
~omparison 3;199:16206:8,10,17 35:7;98:6; 101:22,23, 24;
bining 132:25 77:8;
78:14;
145:2 reference 163:14
105:1;112:14;115:1,3,
mtext-1 190:7
twine 9:4; 1020; 15:16; comparisons 102:14; Wiience 30:4; 35:18; 15,18; 116:2,14, 14;
134:19; 195:20 7:7;40:18; 49:14; 51:12; mrtinue 19:8;41:9
57:5;68:21399:24; 4:1048 :18;71:12; 118:4;11914; 122:21;
112:24; 121:18, 19; 149:3; compassionate 158:7, 2:2,5,9, 14;53:15; 54:7; 123:21,23; 124:4,9;
B:15; 100:6,7; 176:6; 18:20; 137:4; 150:22; ,
157:3; 170:2; 184:3,3; 24 129:3;137:22; 138:8;
38:24 59:23;201:7
195:23;209:6 ~mpetent 210:16 140:3;142:13, 15; 146:13;
onfident 87:18 ontinued 150:6; 151:1;
COmeS107:3; 128:22; ~mpetition 167:17 149:19;162:6, 13; 164:16;
69:24; 194:23
129:9; 163:13; 177:22; omplementsry 16:22 onfining 108:13 167:23,23, 24; 171:6;
204:22 ontinues 40:972:16; 176:9,24; 180:9 183:13;
omplete 27:6; 40:24; onfirm 32:15; 135:1
49:9; 168:3 189:21;190:1; 195:14;
comfortable 64:5; 169:2; 2:21; 140:~ 165:21; onfirmetion 121:9
1782, 7,8; 180:3; 181:2, ontinuing 118:25; 198:19;201:4;203:2, 3;
68:14 onfirrnad 114:15 28:4
3; 1893, 11;192:17 204:23;207:9;208:7
ompleted 89:1; 133:5 onfirms 32:17 ontralateral 4921;
comforting 66:25 ~ouldn’t 6:20; 95:5;,
ompleteiy 89:5; 113:18, onflict 5:9,12,19 3:20,22, 25; 158:22 115:16; 116:8; 121:19;
coming 6:3; 11:21;51:22; 8; 114:24; 132:5; 185:8
148:1; 178:17 onfounding 140:8; ontribute 149:19 125:6; 169:21
ompletion 87:22; 89:4; 46:9; 1798 ontributed 60:16
comment 6:10; 48:4; Council 22:18
32:18; 168:16
95:11; 112:14; 115:2; onfusion 60:24; 170:24; ontributing 11:17 counsaled 137:5
126:15; 131:25; 134:21; ompletions 104:6 77:15 ontribution 29:18; Counselors 22:22
143:11; 154:3; 174:22; ompiexities 159:12 49:18
onsecutive 110:12; count 9:9; 31:18;36:19,
193:16; 195:22; 198:4,6 ompliance 18:21 72:9 ontributions 1/9:6, 10
199:8;2107 21;93:2; 94:5, 5;95:4;
omplicetions 18:19; onsensus 121:18, 19; ontroi 2A”15,25; 21:2; 142:23; 143:1,4,9,10,15,
comment-and 109., 9:20; 20:19; 26:14; %:7, 12; 201:9 6:3; 27:1,2; 3020; 32:22; 8,20,23, 25; 144:4,/1;
commentary 207:6; 51:16 6:1o, 16;37:16,20, 25;
onsequently 72:5; 45:5, 11; 146:25
208:2 ompound 14:6 8:17; 53:17; 56:18;71:6;
6:3; 77:10; 89:15 :ounted 40:18, 21;
, commenting 93:11 ompounds 16:12 2:25; 73:4, 7; 104:15;
onservetive 61:5; 1:18; 158:9, 11; 159:4
comments 6:2, 17; omputer %:15 41:6, ~ 146:13; 179:24;
26:24; 16919; 170:6 ;ounting 134:4
13:19;38:23;49:20 oncentretion 34:4; 84:15; 191:2
:onsider 63:3; 90:19,23, :ountries 191:25; 192:2
.-=—-3;56:3; 57:6,8; 96:22; 9:13; 170:23 :ontrolksd 48:12; 59:22;
14;91:3, 5; 101:8; 116:16, :ountry 123:4; 149:7;
11;107:13; 108:13; concentrations 39:22; 20:14
7; 131:13; 181:8 66:22
?; 127:9;148:14, 17; 0:7 ~ontrols 114:10; 2091:2
.22; 167:7;168:21; considerably 20:9 :ounts 29:19; 31:9,18,
:oncept 120:18,23; :onvenient 20:17;21 :5,
173:20;175:21; 184:lo; consideration 14:5; !1, 23; 32:6,8, 17;33:1;
45:10 fi 166:18
190:1~ 192:8;193:15,24; 19:15;1MJ1O;132:25; 14:18;37:10; 38:1; 60:3;
198:14;200:21; 204:2; :oncern 18:25; 19:6; ,49:2; 193:22 conventional 166:12,13 )2:20; 142:15,17, 19, 21;
206:1 [6:13; 106:16; 139:6; ;onrdderetions 10011 :onversstion 112:2 ,44:17, 18; 145:3,12,16,
,46:9; 182:1,6; 1%:14; :onwqrsion 166:25 [8; 148:11
commitments 56:14 :onsidered 41:16;63:7;
98:3, 18; 200:17; 201:7; :onvey 204:3 :ounts-thet’s 32:14
committed 71:12 11:8,23;102:1; 129:19;
!08:8
Committee 4:5; 8:21; 130:9,11;152:2;171:12; :onvinced 92:21; 132:2; :OUple 20:4; 49:20;
:oncern-is 209:8 179:18;186:23;202:13 53:13;56:3; 59:4; 67:11;
20:3; 22:19;70:22; 71:8; [61:4; 206:15,17
:oncerned 29 18;64:16; considering 90:12; :onvinces 181:4 74:24;81:19; 84:2,4, 17;
89:9; 98:14; 101:8;
)2:9; 132:3; 139:9; 175:23;176:23 }5:12; %:9; 104:1;
111:23; 112:16, 19;113:1; :onvincing 181:9; 191:6
142:10;146:15; 162:8; 127:15;159:18;163:3;
114:25; 125:16; 126:16; :onsiders 105:8 ?1;208:17
185:1;188:8; 190:12; 167:6;173:20;193:15;
130:6; 134:11;149:12; Eonsisted 107:24 convincingly 145:4
194:14 204:18
165:22; 168:6,9, 14; consistency 82:15;
~oncarned-you 64:15 Cornea 12:3 Course 19:7; 59:17;
177:1,6; 187:9;192:3; 102:9;121:213123:18
202:24;204:3,5 Boncerns 17:23; 1812; correct 76:23; 83:5; 69:13;81:5; 97:4; 142:12;
139:8; 197:22; 204:11 consistent 97:9; 100:13; 91:14, 15;93:20 100:4; 158:1; l@.24; 162:1;
committee’s 112:13 102:20; 111:13; 113:15;
concert 61:10 104:10;111:19,21; 166:3; 187:12
common 19:10;42:2, 2; 122:22; 123:5; 130:14; 114:21;128:17;138:1;
43:2;45:7;47:24; 55:19; concluding 57:6,7; covariete 59:19; 93:8,
131:22; 191:15 143:8207:14 12; 137:23; 147:19; 176:7;
172:1 %:23; 99:6
consistently 158:14 correct?-not 92:19 193:7
commonly 45:21; 52:6; conclusion 40:2; 72:2,
consists 14:8; 118:2 COrrSCWd88:23; 154:11 covariates 29:22; 32:25;
54:9 14;75:4; 89:9; 105:22;
111:18; 112:11 constantly 14&l; 200:8 correcting 93:21 34:21; 36:18; 92:2;
community 64:13, 22;
conclusions 37:15; constituents 7:8 correctly 1*22; 209:11 176:22,24; 192:11,15
65:3, 21; 166:21
72:16; 87:12; 105:2O,21; construct 187:10 correspond 75:22 -X 138:13; 147:10,17
companias 192:3
106:11;204:12 construed 187:1 corresponds 62:8 create 111:5; 186:11,22
Companion 9:24
concomitant 39:4; consultant 14:11; 22:23; corticoateroids 48:15; created 194:5
~=pany 102:4; 169:17
141:2,9 23:1656:5 67:3 creating 187:15
nparable 29:16;
i, 16,19,19, 20; concur 99:4; 126:14 consultants 207:9,12 COSTART 42:5,9, 11; criteria 25:10,10, 15,23,
,.6 concurs 71:10 consumer 4:11; 64:16; 43:20; 44:2; 46:6; 51:14; 24;26:1, 18; 28:14; 29:1,
condition 56:12; 124:21; 177:22 53:1 12;33:19, 20; 34:6; 43:6;
compare 68:6; 84:24;
182:2 contained 69:4; 70:21; COStS20:8 61:15;103:14; 150:1, 12;
116:15
conditions 8:17 72:1 could 11:8;33:11;4:4:10 153:3; 158:4
compared 21:16; 114:4;
165:10; 180:6; 187:3,4; I conducted 25:25; 27:7; contains 17:23; 133:21 14;46:17; 48:16; 49:18; I critical 7:25; 15:12;

.- —L3-.43-... ,.-s+1--1 (Q\ Min.lT-?S~fi
Opthalmic Drug8 Subcommittee of the
Dermatologic and Opthalmic Drug Mvkory Crete Ju& 22,1998
16:2~62:21; 93:8; 156:20 cyclosporin 194:12 deal 20:19; 29:21; 69:3;
134:3 determination 26:3;
cross 28:23;40:20;79:6; Cyciovir 167:15 131:17; 141:12; 191:25; demographics 66:9; 74:18; 79:4; 122:11;
—-
151:22; 195:19 cystoid 45:2,3; 52:17 193:9 199:18; 200:5, 6; 69:13,14,18,19 124:15; 183:15
Cross-overs 51:18 205:11,14 demonstrate 7:20; determinations 30:13
cytomegelovirus 17:11,
cross-resistance 17:19; 17;71:1 dealing 203:1 20:24; 38:13; 83:19; determine 68:6; 83:6;
18:23; 19:24; 20:20; cytotoxic 67:9 deaths 7:6; 41:14 163:18; 172::12 88:14, 21; 90:22; 95:8;
55:10; 208:21 Deborah 10:2 demonstrated 21:1; 116:2; 122:25; 124:6, 14;
cross-resistant 161:18 Debra 4:24; 174:2 75:5; 93:9; 144:21; 147:24
crossed 31:1; 59:13;
D decide 10:19 94:13; 171:23; 172:6; 176:10, 21; determined 5:16; 111:12
76:3; 109:8,13 149:1; 181:18;182:15,22; 202:15 detritus 197:8
crossover 30:17,23 D.C 9:9 184:13;186:14;194:25 demonetretles 54:16 develop 8:10, 12; 131:4;
crude 208:16 damn 179:6 decided 68:15; 133:1; demonstrating 170:19; 193:4
CS 164:25 Dan 154:10 169:7; 170:20; 182:25 192:14 developed 53:22;82:12;
CSI 71:19,25 dangerous %:6 deciding 185:2 damonstretion 128:14 157:25; 158:21
(2$31280:2; 132:15, 15; dark 82:25; 91:4 decision 13:1o, 14; demystify 136:15 developing 7:12; 95:20;
133:15,2~ 134:5; 191:20 darn 167:4 24:11;68:14; 84:11; Department 6:19 167:14
CS2 10:11;21:14;27:25; Date 6:4; 7:19; 14:4,4, 12; 115:18; 118:22; 148:22; depend 64:13; l15:18 development 8:14, 17;
28:4;31:10;32:19;33:3; 22:10, 25; 23:5; 24:8, 13; 149:2, 23; 16920, 20; dependence) 101:6 22:2423:1, 15; 167:11;
34:6;38:7; 53:23;54:1, 15; 27:5,5, 15; 29:5; 30:2; 170:6; 193:17,23 208:13,15
dependent 182:7
59:5;68:1;73:9;74:4; 36:1940:11,14,18, 22; decision-we’va 182:22 davelops 197:2
92:3,11, 16;94:17; depending 17:1s;
47:8; 49:17; 53:12, 18; decbbns 81:15; 14925; 194:19 devkas 188:7
106:21,25; 107:23; 54:5,10,12, 14,21,21; 168:8;206:6
108:13;112:11; 138:8; Deputy 4:24; 5:1 devil’s 57:23
55:22; 60:2,20,20 62:14; decrease 7:5;3012;
143:6,9, i>7:17;160:3, 68:10; 70:8, 19;89:2A derive 73:6 diabetic 18:19
12;161.22; 165:8, 14, 19; 36:11;46:10; 48:6; 50:20;
93:3; 95:15, 18;%:7, 19; derived 111::24;122:10 diagnose 1%:4
166:7;167:1;169:11; 55:3,5; 144:12;156:25
100:25; 103:24; 107:3,5, Dermatologic 4:4 diagnosed ?):8,18; 14:7;
170:7;171:7,8,13 decreased 8:10; 21:1;
7,8; 111:4; 115:8; 120:11, daseturation 46:7 18:6;21:18; 27:21, 25;
CS3 77:6; 165:5,9, 11; 19; 123:6; 135:4; 140:7,
26:2;30:18, 21;32:23;
}6:12;37:18; 51:6; 157:3 describe 15:!5,7,9; 28:4;32:22; 36:4; 38:14;
,.- 169:11;170:7;171:7,9 13; 146:1, 17; 147:4;
19:16;21:12; ;[07:11 48:21;54:17; 55:14,25,
CS5 22:5;39:7;409; 149:25; 153:5, 21; 15S24; decreases 157:6
described 18):13,13,15, 25;56:12; 139:14; 145:14;
.—. 72:12;89:1; 157:17 157:11; 159:4; lcillo; defects 48:7; 1%:20 159:19; 160:13; 161:24;
161:9,23; 163:10;165:13; 17,24;42:11; 45:21;
@7 72:22; 158:7 War 101:13 163:4; 165:7; 175:7; 182:3
167:z 168:9;169:17; 4822; 6&16 R53:16
CS9 28:1:33:7;34:6,11, ieferral 123:8 193:25 diagnoses 52:21
170:1; 171:7,8, 10;175:3;
24;37:11, 15;78:13, 19; Marred 74:9 describes 150:4; 169:10 diagnosing 174:10
180:9; 183:3,5,8, 14;
80:2; 104:15;132:14, 15; 184:19;185:X 187:5; Mkiencies 88:23 descriptbn 14:25;45:5 diagnosis 44:21; 45:5;
133:4,12, 19;134:6,20; 189:2; 192:19;194:24; defined
179:9;
191:8; 158:23; 174:14,25;
158:3,14,17, 18; 159:1; descriptions 45:20
195:15;200:24; 201:10; 195:12 175:12
16&4,13; 161:11, 14; *sign 28:17; 72:25;
202:13;204:11,12; ddhes118:22 105:6;123:8; 132:12; diagram 122:19
165:15;166:7;167:1; 208:22; 209:22;210:25
191:20;195:14 definitely 87:20 165:15;192:10 diameters 120:3,4
database 54:23; 59:22; ~efinition 90:10; 128:13; iesigned 15:19 1622; did 9:20; 29:12 3014;
cultura164:10; 65:25;
62:21; 89:5; 91:19; 97:25; 131:15;132:3; 150:18; 73:1;77:21;80:2;89:1 57:12;59:17;61:21; 67:4,
68:17
98:5,9,22, 25; 19S21 177:23 16;68:24; 69:1; 72:3;
culture 172:8 despita 41:12; 95:19;
detebase-1’m 198:20 Wlnitiins 92:2; 1307, 128:1;186:13 7612,16, 19;77:10797;
cumulative 54:11; 60:6, I12:14;83:2,7,8; 88:7, 12;
date 114:11, 12; 118:23; 22;131:22 destined 130:25
10 126:8,10, 10; 181:9 B9:3;90:11,19,23, 24;
~eflnttive 60:25; 77:7; destroyed 131:6
Cure 178:10 91:3, 5; 926; 94:5,5,6,
dates &121, 24; 764; 93:23; 171:13
cures 177:25 destruction 514:25 12, 13;95:4, 7; 96:14;
W16;126:5,20 degradation 17:7
curious 67:19; 68:18; detachment IL9:20;21:3; 97:13, 14;98:3, 4; 101:11;
Davis 131:12 degree 208:9 103:12, 18;104:24;
125:1~ 150:17 25:17; 41:12; 47:1,20;
Day 917, 24; 1023; DeLAP 5:4,4; 204:18; 52:23; 55:1, 21; 150:12; 107:17;108:21;110:25;
current 6:8; 8:4; 70:7; 26:25; 27:3; 44:13;87: 16; 205:24; 206:20,25 151:25; 152:1; 153:3; 112:9,11;113:11,13;
89:22; 103:7; 152:20, 22; 109:11,14;110:1,3; delay 11914; 178:1 197:10,14 115:6,18, 23; 120:25;
181:21 112:10; 153:10,11;
delayed 21:17; 28:3,9, detachments 150:14 121:10, 12; 122:12,12, 18;
CUWt?tItly10:25; 15:4; 157:10; 171:23; 180:14 127:22,22; 128:3,20;
17:18; 19:12;20:21; 21:9; 21; 29:10, 24; 30:4,10, 17; detei121:12; 24:7; 41:12;
days 9:15; 25:4,6; 30:3, 133:12; 139:25; 142:6;
28:2; 38:18;48:23; 55:9; 31:6, 24; 32:2; 596, 12; 107:12; 13921; 172:6;
6,7, 19;31:2, 4; 33:24; 108:16; 109:7,9 143:15; 145:12,21; 146:4,
56:20; 162:11 173:11
34:4; 35:17,19,23, 24; 20; 147:7; 148:12; 150:13,
curve 39:14, 18;74:14; delayed-initially 109:7 detail-my 65:5
36:2,5,6, 13;37:1,2,7, 22;151:10,11; 154:3;
75:21;79:1, 2; 128:16 25; 38:6, 10;40:7; 4923; delayed-therapy 21:15 detailed 23:4; 44:24; 156:11;157:8; 161:11;
CUWed 129:19 50:1,1,2, 7,8; 54:6; delaying 32:21; 178:12 106:22 166:7,20, 21; 172:4;
.

cuwes 77:24; 78:9, 11; 75:12;87:16; %.12, 16 delays 32:20; 178:5 detaillng 26:18 183:2; 191:19,20; 196:21;
79:2;80:13; 107:6 106:23; 108:17,25; 109:8, deliberation 15:12 details 80:6; 134:22 202:17;209:9
cut 91:20; 200:9,9,9 13; 110:14,14, 14; 119:16, didn’t 10:9;60:22; 67:21;
deliberation 169:6 detect 98:1; 142:8
22, 25; 12611; 144:4,10, %:11; 97:16; 113:15,17;
cutoff 145:11 10; 150:20; 152:25; deliver 182:18 detectable 39:22; 40:5
114:6,7; 115:19; 117:22;
cyanoacrylete 194:11 153:11,23;154:19; delivered 205:6 detected 3923 119:13; 122:9; 129:24;
cycle 208:13 160:13, 15; 170:20; 172:9 demise 1103 detecting 49:1,8;99:2 133:7; 134:20,21; 140:24;
Cvclobute 167:13 dead 199:11 demographic 68:22; determinable 37:6 141:5,6; 142:22; 151:22;

Wer Retmrtins! Comoanv. Inc. Min-lT.Scrinti (0> m-n.. .41.4 -9.
Opthalmic Drugs Subcommittee of the
July 22, 1998 Dermatologic and Opthahnic Drug Advisory Crete

I56:1o; 165:.21;166:18; imensional 149:16 85:1; 188:22,23, 25; Iocument 66:11; 194:9; lose 21:21; 24:16, 17;
>— 9; 172:25;195:24 iminished 147:2 91:2, 5; 195:24; 1%:2; 97:3 :7:20,22; 28:7, 19;33:17;
151:19 01:4 Documented 46:18; ,7:19;39:15;41:8;47:2;
iminishing 167:20
Iiseeses 8: 11;63:23 8:7; 117:4 8:16, 25; 50:17; 55:14,
0 4:23; 146:2 irect 57:14; 67:8; 162:2; 6;67:5; 72:1,3; 73:1O;
o,der 95:2;98:9, 19; 70:1, 2,4; 172:5,11,13 Dismissing 72:8 Iocuments 23:2
‘4:6,8; 75:5,6,8, 10;
128:15 irected 166:7 Ilsorder 52:17 toes 13:7;38:13;49:6;
7:10,18, 18;78:2; 97:12,
differed 94:17; 105:21; irection lcKk23 Iisorders 45:19 5:3; @.ll; 62:2,2; 63:13; 3, 15; 104:25; 105:1;
107:25 6:15; 67:25; 71:10; 06:4; 109:13; 154:16;
~irectly 16:4;84:24; Iissetisfied 177:19
2:24;73:3;75:21;78:2; 56:22; 159:24; 160:4,6,
difference 18:3;37:21; 07:5; 172:7; 183:18; Iisseminetion 188:5 1:22; 82:1;86:17;87:1; :4;161:1,2; 168:25,25;
59:9; 66:13,14, 22; 68:17; 85:19 Iistance 118:24 0:3; %:25; 98:9,19 69:3, 12; 170:8,9,20, 22;
79:4, 12;90:9; 93:11; lirector 4:24; 5:1;6:18;
102:8, 13, 18, 19,25; Iistinct 163:24 25:16; 134:8136:20 71:5,7,15,16,16,17,
1:24 Distinction 99:12,13,18, 47:12; 150:9155:2, 4;
103:5,6,9; 106:2; 108:22; 8, 21; 172:12; 195:20
110:14, 17; 121:16, 17; Disadvantages 15:5; 9; 203:23; 206:9,11,12, 77:24; 178:1,1,2,2, :11; loses 30:20 34:3;45:15;
126:2,4, 11;127:16; 9:15 3 79:12, 14;186:25; 189:2;
93:11; 197:3;203:7; 9:3;60:11;79:13; 1%:21
128:22,25; 132:14;133:6; Iisagree 93:10; 94:23; Distinctions 92:9 10ShfJ 20:17, 17;21:5;
5: 13; 126:3 :05:4
138:13, 16;142:21,25; Iietinctty 52:11; 166:1,1 :2:9;48:19; 54:15;
159:24;160:3,19 hsagreed 114:8 Ioesn’t 55:7;93:22; 59:19; 195:6,9; 1%:10
Iietinguish 148:25 25:11; 138:11;169:5;
d“fierences 64:10; Disagreeing 105:3 Distinguishable 8(114 10tS117:8,9
74:16, 19;80:25;81:14, 93:21; 209:15
Disagreement 125:18 Ilstinguished 99:1o Iouble 16:3;60:23; 62:1
15, 16;82:6,8,19, 21; Iogme 161:12
Disagreements 100:22 Distinguishing-have Iouble-stranded 16:11
87:9; 92:17; 93:17, 18; Ioing 9:16; 10:17; 39:7;
Iisappeerance 38:25; 9:10 ~1:7,13;63:2~ 64:4, 5, Ioubt 129:14, 22; 176:8
94:12; 95:4; 101:19;
9:3,15,19 Distribution 18:18; 4;97:13; 118:18; 154:10; )oug 163:13,25
103:1; 105:18; 106:11;
109:21,22; 110:5,6, 10; h3C 33:12; 120:3,3 !9:20;34:13, 14;65:7; 67:I3:17~15;173:12; town 1022; 23:10;
112:4,6; 115:1,3; 127:12; iiscern 140:8 45:9; 156:13 74:io, i80:3; 187:14; iO:14;84:7; 86:3,
14#7:8,
128:10;129:3;130:3; Iisclose 6:3 Distributions 29:15 !W:12 ,4;
100:16;
103:9;
110:16;
134:19;156:7;174:24; Disclosure 6:24 Iiversity 65:25; 179:2; loing-ware 167:10 .28:22;
143:18;
154:25;
.490:2,3 Discontinuation 47:21 91:10 )on 59:3; 125:14 .55:2;
1$010;
204:20
differences-and 111:22 Nvi$ion 4:25; 5:2; Ion’t 11:8, lU 56:20; )R 4:13,15,17,22, 24;
Ilscontinue 165:14;
gJ%yent 8:3; 21:21; ,66:18; 170:6 .34:20,22 i7:7;60:12; 61:2; 64:4, 10, ;:1, 4,6, 10; 10:2; 12:2,9,
-“?;31:7; 35:14;68:19, .1, 15;66:3; 67:14;68:23; .0, 10; 13:24; 14:8,10,10,
Discontinued 47:7; )NA 16:4,11,17, 18;
>9:18;74:17; 76:1; ‘5:15; 81:12; 84:15; .6, 18; 15:10, 13;21:12;
.50:14 .7:18; 18:23;19:13;20:3,
,79:3; 80:23; 83:16; ~,21;21:10;36:3; 161:16 Kk17;93:10,16,19, 20; !2:3, 15, 15, 22; 23:7,8,8;
~>:4, 5,6, 17;86:3, 5,11, discordant 93:5 )5:14, 15; 102:7,12,17, !4:20, 20, 22; 25:1,2;
discrepancies 94:22; jO7:19, 2~ 9:16; 11:9; !6:8, 13; 57:5,7, 12, 14,
21;91:24;98:24; 100:11; ,9, 24; 103:5; 117:24;
,07:20, 23; 119:19 [3:14;19:6 23:22;305; L5,16,17, 17,21, 22;
102:21;103:10,12, 18; ,181; 119:23;120:19
[25:25 ;3:10, 17;54:24;57:8; ;8:1, 10, 13, 14, 16, 17,
111:24;122:6, 17; 126:1, ~23:24;125:3; 127:1Q
;9:22;60:15, 17, 18; 19,20; 59:4,4,10,15, 20;
21; 130:2;132:23,24; discrepancy 94:20 [28:21;12912; 131:17;
;1:14;62:9;63:2,3,9, 17; 50:17,19;61:6, 10;62:7;
136:21;145:4;147:15; discrepant 108:9 134:25;137:2; 139:21;
ii:l; 65:13;6&10;67:24; ;3:1, 1,6, 13, 14, 18;
154:16;155:9,9; 159:16; iiSCUSS12:22; 121:15, [46:7, 10; 147:8;150:4;
%:11;69:20;79:24;81:1; 54:20 65:2; 66:1,8,17,
160:18,20,23; 161:5,6,7; [7; 133:18 ~60:6;162:1, 12; 175:B;
13:~, 87:25;8&4;89:4, ~l;67:15; @l, 22, 25;
168:17;177:7;188:18,21; 176:23;178:6, 14; 179:21,
iiSCUSSSd21:14; 12;90:8;51.9; 92:1;94:4; Z2;Iwl, 3; 181:8; ;93; 70:16, 18;75:18, 20,
189:2;193:11;208:7
131:16;203:15 35:9;%:15; 97:14;99:21; 23;76:9, 14,23, 25; 77:1,
different-or 74:25 103:7,16106:3,10,15, 182:23,24; 183:3;185:21;
~iscussion 14:23; 15:2, 186:18;187:20;189:@ 2;82:19,20, 22; 83:4;
d“tierential 94:2,6 12;17:21; 22:4,7, 14; 24;108:14;115:14; 116:6,
190:23;191:3,7; 193:18 39:25;90:1,1,5,8, 14;
differentiate 78:7 75:25;78:13; 94:17,19 12;118:1; 120:14;122:10; 31:11,12,15,16,17,22,
194:2,4, 22; 195:6,25;
differentiation 99:6 106:20;112:1; 113:2 123:4;124:6 126:2; 23,25;92:1, 1,6, 15;
127:17;128:19; 129:2, 17; 198:8,1~ 200:21;2011:5;
differently 62:3; 74:24; discussions 5:20; 12:17, 202:3,11;204:8, 24; 93:10,24,25, 25;94:4,10,
97:4; 112:4; 128:24; 24;82:19; 94:16 134:25;135:3;137:5; 16,21, 25;95:5, 13;%:5,
138:23;140:24;141:2,23; 205:24;208:15;210:6,9,
154:5; 194:10 disease 7:11,12, 17; 12 9, 14;97:2, 23;98:22;
142:6; 144:16,1$$146:1; 99:13,21,23,24, 24;
difficult 18:10 48:17; B:22;9:19; 14:7,7; 15:3, 151:5;153:6,12;159:12; don’t-1 189:5
60:13; 85:7, 23; 86:15; 20, 22; 16:1,7; 18:5,9, 10; 100:4,5,13, 21; 101:3,10,
161:8,9; 163:11;168:20; don’t-l’m 178:7
112:4; 117:22; 118:5; 19:7,8; 2015,19, 25; 13,14, 15; 102:7; 103:17;
169:4;170:7,23; 171:5; Donald 4:15 104:10,12,13, 20; 105:7,
122:25; 123:2; 124:16; 21:10; 24:1; 26:3; 27:21; 172:13;173:10,14, 16; done 26:10, 19,27:8; 11;1C61,9,12,14,21;
133:8; 142:1,4; 147:17; 28:6; 32:22; 36:4, 10; 175:11;176:17;177:25;
162:9; 168:1,3,4; 174:7, 37:20; 41:19; 53:20,21, 31:11,17; 46:15;62:17; 107:4,11,14,17, 21;
178:17;179:2; 182:1,16; 66:2; 67:16; 73:25;82!:22; 108:2; 109:3,6,10,16,18,
9,21; 180:11; 192:13,23; 22, 25;55:15;61:11, 18, 183:24; 185:19 188:2;
1%:4 20;62:11, 19;68:3; 69:15; 84:22; 89:6, 7,8; 91:20; 24, 25; 110:18; 111:9,10,
189:15,25; 190:13; 99:22; 102:15; 103:l~; 12,22; 112:1,2,13,23,
difficult-to-read 11i:25 75:2; 81:19,20, 22; 82:3; 192:13,23; 194:6,9;
95:15,17, 21; 97:6; 107:2,8, 10; 110:2, 17; 24; 113:4,7,10,13,20,
“—-”cult-to-take 18:20 197:9; 198:5,23; 199:8, 111:1,4, 19,20;112::21; 24; 114:8,22, 25; 115:4;
109:11;115:23; 116:1; 19;200:14;202:20;
./cuities 7:23; 77:9; 113:15,21;114:17; 119:8 116:8,15, 19; 117:22;
118:11,15;11916,18,21, 203:17;206:2;207:2;
18 137:12, 13; 146:20,21,22 118:17;1196,11,11;
25;120:1,2; 130:12; 208:2
k.,llcuity 8:8; 18:18; 131:4; 149:16; 151:16, 25; 147:4,22; 153:9,10, 11; 120:11, 16; 121:2,3,3,10,
70:4; 117:5; 122:15; 157:21,23, 24; 158:5, 18; do-the 66:18 161:6; 16622; 182:2:2; 24; 122:7,9; 123:2,23;
147:14; 199:14 159:2, 20; 166:1,1, 14; doctor 9:18; 182:17; l$X18;191:21;205:18; 124:8; 125:6,8,15,16, 20; “
dilemma 208:14 167:3,8, 19; 170:19; 187:10 209:20 126:9,14,16,21, 24;
dimension 148:18 172:1; 173:1O;184:24; doctor’s 9:11 doorstep 205:25 I 127:4,4,5,11, 19; 128:3,
OfXhalmic Drug8 Subcommittee of the
D&matologic ad Opthalmic Drug Advkory Crete July 22, 1998

17;129:7, 14; 130:1,4,5; 05:9;
109:1;
117:1; 8:10;72:3;88:1; 134:8; encyclopedic 149:9 87:1
.. ..
131:14,16, 19,24; 132:7, 21:1; 136:24; 71:17; 179:10; 188:1
123:11; end 27:16;40:17;49:11; !ra 59:21; 139:12; 180:8
9,10, 21,21; 133:14, 17; 48:23;
165:4;
172:7,8, ffectively 48:12 51:8; 133:9; 139:23; !RG 198:25
134:1,9,14, 18,18,21, 6;173:21;
174:5,9; ffects 10:6;18:18;20:5; 146:24; 170:12,21;
hnona 4:21; 5:8
23; 135:5; 137:21; 138:1, 75:10,
18;
178:11,23; 1:4;57:25; 146:10; 171:23;203:8; 205:12
2,4,5,6,7,12,17, 20; 80:22;
181:19,
25;184:7, 71:24; 172:1O,17; 176:9; lrroneous 210:1
ended 7618; 134:5,7;
139:2,6,9; 140:10; 143:6, ~;
186:16;
194:7;200:1; 88:22,23, 25; 1%:24; 151:12 lrror %:17; 100:9
7,8,9; 145:25;146:15; !04:10;
208:8,
12;209:21 08:16 ending 140 ].9 !rrors 78:8; %:15; 100:3,
147:5,7,8,13,14, 22; Irug-reieted 169:22; fficacious 22:8; 24:12; ,6
endophthalmitis 44:22;
148:3,6,9,12, 14;149:4, 70:5 7:13; 3812, 17; 182:13 scaleta 17020
52:20, 22; 58:7
8;151:3,10,13; 152:14, )rugs 4:3,4; 10:7,8; !sCah3tiOn74:7, 8; 77:18,
fficacy 14:4, 13; 21:13; endpoint 28:9; 33:17;
22, 23; 153:4,5,7,14,20, ,5:18,
23;16:9,
13;
17:8; $; 170:8; 171:5, 16, 16
25;154:1,4,9, 12,13, 15; 2:2; 24:4; 25:20; 27:14, 88:16; 150:13; 175:14,15
,9:16,
22;20:5,14,20 5; 28:1,$%29:6; 36:3; specially 19:5;%:2;
155:5,5,7,8,12,16,18, !1
:9,26:
17;
55:9;
56:20; endpoints 2’5:20;102:6
19,24; 156:1,1,3,4,5,10, 7: 15;38:4,13, 22; 48:25; English 123:21 16:20; 1%:3
,48:22;
173:7;
184:3,
4; 4:13, 16;56:25; 62:12,
12,16, 24; 157:2,6,7,8,9, enjoying %:17 Ssance 66:18; 122:23
,88:6,
9;200:2;
208:5,
18; 5,20, 22;73:5, 22;75:5;
14,19,20, 24; 158:1,2,9, !09:9,
25 enlighten 162:13 !esentially 97:18; 128:7;
11,12,13,16,20,21; 9:5;87:13;91:2Ck92:16; 32:22; 160:25;203:3
)SMB 168:15 3:9;%:2, 24;97:1, 15; anorrnous 54:21; 186:9
159:7,8,9,10,11,15,16, stabiish 73:5; 189:19
18;160:8; 161:21;162:1, lual 84:23 05:23; 106:3;119:1~ enough 13:14; 24:13;
27:2; 128:13;155:14; @24; 75:6; 7922; 81:23; stebiished 103:15;
16;164:23; 165:2,3,5; iucking 177:18
61:6; 164:25;165:14; 87:19; 88:13; 97:14; 21:13; 131:2~ 176:13,
167:7;169:8;172:24; iue 47:22; 54:19;88:9 6, 18; 182:16, 19; 190:3
173:5,16, 19;174:1,2, 11; 75:14, 15; 176:1,10,12, 137:1; 148:2; 162:12;
iurable 18:4; 20:15; dablishing 122:15
175:3,22, 24; 176:3,4,11, O;177:23,24, 25; 178:11; 169:3; 181:2; 183:9;
!1:2; 37:16,25
12,14,15,19,20, 25; 79:9, 25; ltW22; 184:20; 189:3;204:14; 210:9 !atimete 87:16; 93:12;
iuring 44:9; 59:17; 83:2; 874; 1893,12, 14;
177:1,>;178:19; 179:4, enroll 73:17; 166:2 38:7, 9; 147:20; 148:5
156:20;158:1; 165:23; 905; 191:17;192:15;
18,2~’. ‘. 3,8,10,11, [66:3 enrolled 10:11;31:10; !etimetes 9$:22;%: 11
11, 14;182:20,21; 183:6, :01:23 tihical 168:20
34:24; 39:%61:9; 72:13,
7,16,21, 22; 184:1, 19; ffm’t 8:10; 112:3; 19,23; 73:1, 12;77:14; Nhnic 134:20,22
,.- 185:5,6,16, 22; 188:20; E 4017; 148:24; 170:8 78:20; 140:18,19 Wrope 132:16
190:17,23; 191:12, 13; dbt$ 111:25 anrolling 7:23; 8:9
192:7,8, 22; 193:1,14,15, iuropeen 80:3
.—. sach 24:24; 25:12, 15; light 76:15;77:20 enrollment 40:8; 73:11;
15, 20; 195:2,3,4; 1%:17, ~valuability 91:9
z7:7;36:13; 62:3; 73:21; Jther 71; 38 16;39:9, 77:11; 80:7; 166:9
18;197:5,6,6,9,9,14,21, 12:13;94:13, 19;95:1; !4;43:12;48:13; 62:11; rvaluable 77:16; 78:21;
23, 24; 198:4, 14; 199:1,9; anter 43:8 )0:10;90:8,10,19,23, 25;
)6:22; 104:22; 110:16; 11:16;82:24;%:21; 95:2;
200:19,21; 201:23, 25; entared 42:1.8,20; 50:23; )1:3, 5,9 101:25; 114:2;
111:13;118:4; 155:13; 02:15; 110:21; 119:16,
202:2,3,4,5,6,7,19,19, 51:7; 53:21;156:22; .15:5,7,8, 17; 118:9, 10,
160:15;179:19 !0; 137:19; 161:5
23;203:22, 25; 204:1,7, 15817; 159:3; 171:14 12,14,20; 119:10
eerliar 49:12; 76:1081:1; dthar-1 12913
18;205:24;206:20, 25; entering 43:6 waluete 6:2; 46:17;
207:24;208:4;209:4,5,7, 33:8;86:4; 8&22; 98:7; dectroph ysiological 70:lo; 73:15, 22; 74:2,4,
10t124,24; 106:12, 16; entire 43:22; 44:21;
17,18, 18;210:3,4,13 .%23
52:25;694; 114:1 11;82:23; 85:23; 87:19;
120:25; 139:25; 141:5; demerits 112:14
draft 70:21;75:23, 24 antirely 16:1.2,14,16; )1:7 ;111:25; 115:16;
145:9 163:24; 165:24;
dramatic 183; 32:7; Nigibility 43:661:15 88:8; 8920; 1.28:24; 128:3
192:9;208:4
110:6; 112:6; 115:3 Nigible 158:5; 162:9; 14618 16(122; 189:18 3vahmtsd 25:15; 3~.ll;
Mrly 16:23;44:11; 45:13;
dramatically 78:11; [65:8; 207:18 entity 14:22 75:11;102:10,11
46:9; 5610, 11;88:7;
98:10,20, 24; 128:15; 120:9,14, 25; 127:14,20, diminete 144:23,24 entry 50:19;92:19; avalueting 103:7; 170:9
139:13 23; 128:2; 14019; l@.3; dimineted 117:19 143:22; 144:“1,2,3 Evaluation 5:4, 18; 23:6;
drastically 191:4 201:21 Webath 5:6 environment 167:17, 21; 26:16;81:3; 100:11;
draw 72:3, 15; 122:19; ea$~;ehattaringly doquantiy 19(k18; 16S1,2; 186:11,12,25; 114:9;116:19; 133:13;
129:17; 131:8; 188:4 205:21;209:8 187:16, 21; 1W5; 199:6; 170:21
Drew 4:19; 131:19 easiar 182:18 dee 12:5;60:9; 762~ 200:8; 2065, 5; 208:9 evaluation 25:23;
driven 76:21; 205:4; 113:1;119:4; 131:15; anzymea 15:20 78:16, 17;91:20; 94:9;
easily 44:14
206:2,3 141:19;187:19 EOG 199:1 108:6; 114:4, 5; 122:22;
easy 42:4; 210:19 166:7
drives 208:17 EC50 17:11;40:8 dse-about 45:12 apidamic 18:3
evaluators 94:11
drop 18:6; 25:19; 35:10; edame 45:2,3,4,5; ducidsted 179:23; epkiemiological 181:23
170:7 184:23 even 5:13; 38:1;43:8;
52:17,17 epidemiologist 191:24
46:23; 75:8,13,13, 15;
dropout 29:11 edematous 131:7 Emily 4:17; 157:13; epidemiology 191:4;
192:25 77:13; 98:3, 4; 103:19;
dropped 155:1 edge 33:10 192:12 106:24; 113:15, 19;
drops 140:6 emphasize 37:24; 7922 epiretinal 45:19 115:10, 15; 118:4,20, 25;
effect 15:22; 2919;
Drs 14:14; 148:16 32:15,18, 24; 67:8, 9; employed 209:3 episode 1(YB:8 126:18; 127:23; 1,28:13;
---- ORS-style 67:17 68:6; 70:8; 88:3; 92:23; employee 207:11 epithalial 1’7:12;98:8 142:1; 143:11; 167:16;
97:1~ 138:7, 18; 139:12; enables 17:6 172:8; 176:8,16, 23;
Drug 4:25; 5:3,4, 18; epithalium 48:5
144:15,20, 22; 145:6; encephalitis 210:21 181:12; 182:5; 184:9;
7:15,20; 8:1; 11:7; 12:13; equal 48:25I
14:2; 16:16; 20:14, 25; 146:13; 147:1, 2,20,21; 188:14; 189:24; 192:20;
encoded 16:7 equivalence 180:18; 200:5
21:8; 23:15; 25:4, 5; 26:6; 148:4,8; 172:11; 176:24;
178:24; 180:1;189:1; encourage 8:11; 173:6 191:5; 192:16
38:25; 39:1,3,5, 12; 40:3, event 5:19; 27:10;41:2;
195:10,11, 16;208:25 encouraged 7:5 equivalency 193:5 43:3; 49:16, 20; 53:5,7,
13;41:17; 47:12; 50:8, 8;
52:4; 53:3; 57:3; 60:13; effective 7:21; 21:8; encouragement 172:22 equivalent 44:14; 46:19; 10; 58:8; 60:6; 71:8;
67:9; 68:2, 6; 97:10; 102:4 27:17; 32:20; 55:13; encumber 194:2 125:9; 180:5; 181:5,21; 108:18, 25; 110:19,22;
...— .-
Opthahnic Drugs Subcommittee of the
July 22, 1$?)8 Dermatologic and Opthahnic Drug Advisory Crete

111:11;1127; 114:1; 145:19; 153:1; 162:2; external 29:2 faiiurea 161:1o;208:2 83:23;
104:3;
119:7;
152:3;16922 201:7 extraocular 34:9; 53:13, faintness 122:15 126:3;
136:8;
143:11;
=—=nts 26:6;41:6,9, 10, exception 19:13; 34:7; 17; 195:22, 24; 1%:2 fair 43:10; 67:9 148:14;
149:23,
25;
5;42:2, 22; 43:25; 40:16; 47:11;52:13; extrapolate 66:16 153:11;
156:19;
168:21
fairfy 23:22; 50:9; 641;
am.L;47:8, 16, 18, 20,22, 125:21 axtremaly 18:10; 149:17 fibrinoid 44:18
23;49:15; 53:12; 54:lfJ 78:11;81:15; 128:12;
excess 38:1050:1,1 Eye 4:17; 9:10, 18; 10:15; 210:19 fibroblasts 17:13
55:18,19 57:24;58:5,9, exchange 20:9; 121:8 11:3; 12:3;22:18,20, 22; fSirnS$S 6:8; 209:13 field 46:18; 48:7; 52:10;
11,15,21, 24,25; 59:24;
exclude 5:22; 16s16 269, 15; 51:16 532(J 55:6; 1%:20
60:8,14, 16;79:10, 11; fall 135:2
excluded 34:8, 10; 107:9; 62:1,1,3, 16;81:11; 90:9,
97:20,23, 24; 98:6, 18; fallen 19:5 fields 46:15,15
145:21;191:9,9 10; 136:2~ 137:1; 149:7;
99:2; 121:14;151:8,15, 151:18; 155:13,21, 23; falls 124:17 fight 7:4; 9:21
17, 17;155:14;171:25; axciusion 5:23; 29:1;
157:25; 158:3,9,22, 24; fd$e 117:3,13, 19; 1;!0:8, figure 105:1; 1m21
198:19;2~”:25;201:2 32:12, 16;34:6
160:25; 181:24; 182:3,11 10, 15; 129:1,5 filing 152:20
events-and 41:23 axcuse 200:10, 14, 14,
15; 205:8 eyes 24:5,16, 17, 18; familiar 99:3; 120:18; fill-in 117:6; 129:15
events-recording 41:2 25:4, 5,6; 32:12;33:10; 12%4; 184:6
execution 192:10 filled 203:2,4,6
events-that 49:18 34:8;35:5;36:15;38:5; far 101; 42:8; 47:9; 54:6;
eXt?rCiSe125:13; 184:18 40:15,15,16,18, 21;41:7; filling 83:25; 95:3;
fSVt?MUfdfy119:21 68:11;77:16; 79:5, 14; 129:21; 207:5
exhibited 184:8 42:6;43:7,8,14,21, 25;
ever 75:14;99:9, 10; 62:12;86:12; 88:12; filling-in 129:18,21;
exist 81:12 44:20,23;45:947:2,3,7,
149:19;182:25;191:5 10, 21; 50:6,7,8,9,13,18, 91:21;92:8; 93:12; 94:17; 130:23
every 6:23;9:7, 11; eXiSting 25:14; 177:12 98:2; 103:6; 126:8;
eXit 150:1, 12; 153:15,16
23;51:4;53:6, 21; 54:5; filhg-hi-! 129:24
10:24;17:4;19:22;28:20; 127:14; 130:22; 148:11[;
57:18,25; 58:2,3,4; films 1189
34:1, 5;45:18;493,3; expanded 19&23 61:25;62:4,7,10, 22; 182:11;190:17; 194:13,
55:3,4;67:7;78:16; ~xpact 129:4; 159:24 21 final 121:20; 122:11;
53;4;68:16; 77:16;78:22;
107:15;110:17,23, 23; farther 76:4; !?5.‘.3 127:9; 150:17,18
2XpSCtSnCy182:9 30:10;91:16;94:2, 7; 98:2,
111:13;118:1,1;123:-, i; 152:11;154:17, 19; Iarthest 12.,:17 finally 24:7; 27:9; 56:3
sxpactad 87:14; 97:6
125:21;132:25;136:17; 155:6,7,9,13, 16;157:16 finances 194:15 ,
104:5;162:6; 18(Y1O; Iashion 21:16; 26:10;
137:11;145:13;184:15; ~ol:4 158:4,15,19, 19; 159:1,3, 155:15;192:24 financial 5:21; 6:9
195:23;21018 T;169:13,14, 14; 170:10,
~xpense 201:13 bst 79:25; 97:14 find 11:15;63:11;94:1;
~verybody 4:2,7; 71:5, 11,12,16, 19; 181:17
‘ 14;75:14; 100:18;131:25; 3xpenses 7:2 ‘aster 97:5 102:12;108:21; 141:15;
#yes-and 57:22 146:25;147:6,7; 162:9;
144:25;150:6;168:22; nrpensive 194:16 * 18:18
#yesight 9:21;1015 168:4;171:17;191:2~
~yn15; 188:7;207:15 sxpensive-1 194:15 fSVOr 133:2,23; 152:17;
194:13
‘body-or 189:9 !XperienCe 23:18; 49:7, 207:6
everyone 12:11 !2; 50:9;61:3; 123:4; F favorable 20:15; 48:20
findings 97:9
[31:2; 139:22; 15023; finds 141:il
everything 142:3; favors 48:2
line 11:3; 153:14
146:22,24; 208:17 ,55:9; 166:16,16 173:22;
‘10:10
ace95:20; 122:24 FDA4:21; 5:5,7, 21;8:12;
everywhere 45:12;65:14 12:17,24;70:12, 17;90:3; finish 15:13
aced 65:4; 148:21;
!xperiencad 5912; :99:13 %18; 102:4; 105:8; finishad 171:10
evidence 28:22; 42:18;
.63:1 107:2~ 1102,15, 22; finishing 164:22
54:ll;6&13; 67:&83:9; acing 56:19
%:23; 97:1; 114:14; !Xpariencea 27:lq 41:2; 126:10; 133:16, 17; firm 6:9
act 9:6, 25; 19:18;64:25;
139:18; 169:25; 170:4,13, iO:3;1%:13, 16; 198:2 137:20; 177:1(J 183:10, firmly 57:2
)5:17,21;%:3; lo&9;
15; 171:1; 176:1; 178:11; lxperimants 17:15; .04:8; 105:23;108:8; 14;184:16; 191:9; 194:25;
firmly-l 57:2
17911; 180:4; 181:4,9 72:8 206:1
.09:10 113:14;116:25; firma 5:17,20
evident 12:22 !xpert 65:21 ,19:8; 120:15;122:16,24; FC)/1’s5:25
first 4:3, 6; 6:13; 13:22;
evolution 117:9; 131:5 IXptain 1293; 134:11; 23:12; 128:14; 129:8; fear 9:ll, 25; 186:3
14:9,20; 15:15;21:14;
ex-lV 186:16 45:5; 17624; 185:20 .32:2Z 133:3;141:13, 17; feasible 146:21 23:12; 25:23; 27:12; 28:3;
!02:20 .45:10; 169:21;180:6; February 163:14
exact 51:4; 205:3 32:14;33:19; 384, 11;
lxplained 176:9; 19&17 86:13; 191:18;205:7 43:5;50:16; 56:5,7; 76:19;
exactly 88:6; 124:16; fed 7:24; 8:7; 11:16;
explaining 209:19 act-we 145:10 8&13; 115:3 1292; B1:19;84:25;W3;91:1O;
125:23;129:10 154:13;
204:8 lxpianation 92:23 actor 37:11; 102:20; 136:20,25; 137:2; 149:8, 10&20; 105:24; 108:15;
Ixp[anations 139:24 41:17; 162:17; 193:23 18; 164:17; 1691; 173:1.7; 109:10;113:24; 114:20;
exam 27:1; 51:5
SCtOrS146:14; 179:23 180:3; 182:11; 183:11; 115:5,25; 116:17; 119:7;
examination 25:12;27:4; txploding 167:12
act$ 26:19; 66:25; 185:14; 189:3, 11; 192:1.7; 120:20;121:11; 125:15;
210:19 exploration 195:5,8 207:16; 208:2 127:15,21; 139:10;
23:17
examinations 26:1; 27:6 !xpIore 702 feeling 62:4, 5,6; 133:9; 14010; 148:16; 150:1;
acuity 56:4
examine 117:25 !Xposure 25:3,4, 5; 136:23;204:14 153:6;160:2; 169:13;
aiI 18:15; 19:8 172:25;174:20;175:25,
examiners 100:11 9: 10; 50:6,7,8; 98:13, faeling-1’m 62:4
5, 20; 150:4; 172:8 Eilad 7:9; 1024; 33:10; 25;184:25,25; 185:7;
examining 118:12; 151:4 feai$ 136:19
‘XpreS$ad 204:4 ,6:7;37:3; 45:9; 8916; 188:11;194:6; 1%:7, 21;
exampie 38:25; 58:6; 12:25;104:13, 19; 105:8, fall 166:4
‘xpression 16:24 203:15;207:3,6
60:8; 115:21; 117:21; o; 161:16; 179:15, 17; fait 47:12; 62:21; 109:1!5;
1~’-=~; 131:2; 161:9; Mended 25:18; 152:3 fkst-line 8913,13, 20;
80:23; 187:19; 188:15; 115:6 133:7;164:213 29:7;179:15, 17; 180:4,
; 169:4; 188:18; XtenSiOf!72:22 89:4; 202:15, 18;205:24; 165:16;171:17; 184:8;
.1; 210:17 23;181:1,4; 183:4, 19;
xtensive 3313; 34:16; 08:6,19 204:10 186:7,24, 24; 187:7;
examples 116:20 0:9; 92:13 Biling 36:15;37:25 female 69:6 188:15;189:4
exams 40:24; 78:17 Xtensively 92:6 Bits 137:5 females 64:9;68:19 ~ ‘irst-line-l 99:11
excellent 118:17; 153:18 xtent 37:14; 44:20; 73:2; ~ilure 26:4; 159:22; few 8:13; 15:3;38:20; ‘irst-tirna 147:18,25;
except 45:24; 53:23; 3:18; 103:24 62:24:163:2:203:5
.-— ,-. 41:10;43:5, 14, 25; 51:1’5; I [48:1
evente - first-time {12) Min-lT-Skrini6 wall-. U.nn+$a- O.-a. -.. T-.
Opthalmic Drugs Subcommittee of the
Dermatologic and Opthaimic ~ Advisory Crete J@ 22, 1998
fii IW; 15:8; 173:8; 4,5,6,6,7,12,18,19,22, 16;
201:4;
202:16;
203:7; 20; 12:22; 13:12; 14:15; 76:12,15, 15;94:11;
193:11 25; 15:5,7, 12; 16:16,23, 204:23;
205:2;
206:8,
11; 15:10; 16:3; 19:23;22:3; 106:15; 107:3; 108:1;
_- -- fits 20:23; 189:20; 190:7; 25; 18:8, 24; 19:18,18, 25; 207;4,
4,19;
208:14; 23:10, 20; 27:6, 16; 30:17; 111:8, 16; 112:10,20;
1%:10; 203:11 20:7,9,14,20,23, 24; 210:1,2,17,21 31:7; 32:12,16; 33:12; 122:18; 131:12; 174:25;
fiie 22:19; 30:25; 58:7; 21:8,10, 12; 22:7, 11,18, for-the 150:10 36:5; 37:15; 39:4,17, 23; 175:5,7,15
99:8; 167:22;206:9; 19,20, 22;23:12,16, 23; forced 10:7;81:6 40:3, 20; 41:11; 47:22; further 15:24; 23:20;
207:23 24:6,17, 24; 25:1,4,5,6, 49:12; 55:2; ‘5621; 57:lq
31:14; 63:3; 67:6; 105:12;
16,23, 24; 26:5,15, 18; forego 182:16 59:2; 60:11; 64:21, 23;
flight 201:21 109:12, 14; 128:7; 190:9;
27:17;28:15, 19;29:3,12, Forgive 25:1 65:24;68:20; 69:8, 16; .
flip 84:25 195:5,8; 1%:15; 197:8;
16,24; 30:3,4 ;31:11,13, form 30:3; 35:17; 37:1; 72:3, 19;75:4;87:12;88:2, 20(k23;208:14
f!ip-SOrry 85:4 15, 17,17,19, 21,24; 171:15 25;89:9;91::12;95:18;
floor 57:11 Furthermore 18:16;
32:1,3,11, 25; 33:18,19, formal 166:6; 195:21 98:10100:8,,10, 11;
fluid 63:10; 66:5 22; 34:8,14, 21;35:8,17, 101:7; 105:1:2,19; 106:2, 172:10,
formalize 203:16
fluids 65:24 23,25, 25; 36:3;37:2,4, 12;107:3,4, .25;108:22; future 8:lo, 13; 19:25;
11, 12;38:3, 20; 39:8,12, fOrMS[iy70:25;94:5,5 111:4,24; 114:1,20, 22; 72:18; 133:18; 155:23
fOCi 130:12; 131:4 format 46:1x 49:24
14, 18;408, 12;41:5; 1165; 1181:1;120:3,12, fuzzy 86:1
focus 41:23;79:12; 20; 123:6;127:3,21;
42:1,4, 10;43:2,6, 12,15, former 22:15
80:18;86:12; 106:20; 128:9,15,15, 18;129:5;
110:13 20, 25;44:24;45:2,4,22, forms 42:15
24;46:2, 15;47:1,3,10, 13O:1O;131:I,2,5; G
follow 42:4;63:2;93:25; formulary 200:11,15
24;48:20;49:1,3, 14; 132:15;136:4; 140:7, 15;
%:22; 115:15;118:7; formulate 701; 161:20 144:25; 145:4,13, 23;
5O:1O,12;51:3, 15;52:2, G 167:13
127:22;142:15;143:15; forth 60:23; 63:23; 146:2,3; 148:18,25;
179:13 24; 53:23;54:1,6,16, 20; gain 72:11
55:25;%:1, 3, 24; 57:6, 108:17; 124:22; 151:8; 1493, 19; 153:16; 154:25;
follow-up 27:1, 3; 58:10; 161:7; 1691; 201:1 155:2, 16;1543:14;162:5, gained-are 72:10
11;58:5,6,7; 62:15, 15;
W.18;91:23;94:q 1207; fortnightly 78:15,16, 24; 7, 18;163:6,1,3,17,22, Sanciclovir 8:5; 10:5,
64:7;65:6, 7;67:1, 17;
129:1 134:1; 150:2,5,10, 79:13, 18;80:11, 17,21; 24; 165:25;167:8; 168:24; 1~ 17:14; 19:14,21;34:7,
69:3,13, 14;71:1;72:22;
10,25; i51:2, 5; 152:2,4; 87:25 173:20; 174:4; 175:1,2; 10,11,20; 35:4,4; 37:14;
73:24, 25;74:17;75:7;
153:18,20; 156:15,21; 177:7;178:18,23; 179:11, )9:8; 53:24;68:4; 73:25;
77:17;78:15,22;81:2,14; fortunately 210:23
161:21;164:11;210:15 12; 183:7;l&$:7,12; ?4:1;77:8, 197%3; 98:23,
82:6,13, 14;84:23;87:16; fortune 149:13
foiiowed 28:22; 49:3; 187:15, 17;189:4,9, 10; 24;99:9; 102:11, 11;
.< 89:9, 16;90:18;91:2; forum 12:6
139:17; 140:16; 142:20; 192:8;1%:24; 198:16; 104:16;121:1;125:22,22, ,
92:23;93:20, 21;94:24;
143:1; 150:21; 162:25; 95:22;%:3; 97:24;98:14, forward 63:2; 75:19; 199:3;204:25; 210:18 ?3;126:17; 149:13;
–—= 165:10 189:12 front 7:3; 18:23; 25:14; ~61:10;163:15;165:11;
— 23;99:8,14, 15;100:12;
following 5:11; 40:6; 101:20; 103:14;104:15, Foscarnet 8:5; 10:4; 81:7;98:22 ~67:15;177:13;186:17,
94:18; 174:10,15 25;105:6,8; 106:4; 107:1, 35:4;73:25; 98:23; front-line 20’5:19 ?1;197:11
follows 37:16; 177:6 23,24; 108:2,23; 109:5, 102:12; 104:16; 121:1; Frost 6:3; 11:24, 24; ~anciclovir-fomivirsen
12;110:10,15,15, 19; 125:22; 163:16; 186:18 75:18,21; 76:;6,11,21, 24; [65:9
fomivirsen 7: 14;8:2, 21;
13:25; 14:5,13, 20,29; 114:19;115:2,9, 21; found 44:14; 48:15; 95:10, 11;%:,21;97:16; lap 83:2
15:1, 15; 16:17,20; 17:10, 117:15,21;118:23; 108:7; 141:15; 17025 98:9;99:4, 17; 112:19; 3ardens 11:5
16;20:23; 21:21; 22:8,9, 119:16,19,22,24, 25; found-we 44:11 113:5,6,11, 14; 114:18, :a~ 26:8; 105:19; 118:7;
24; 23:6; 24:7,12, 12; 121:19,24; 122:12, 14; Foundation 11:25 24;116:5;118:6; 120:7, .20:8; 129:2; 131:10;
25:3; 27:9,13, 17; 2&2q 123:10,10, 15; 124:5; four 9:24; 10:23; 26:1;
12;125:5; 126:13, 14; [49:8
30:11; 32:15, 20; 37:16, 125:1,1, 20; 126:22,25; 44:13;54:1; 77:19;
127:18; 128:9; 154:10;
~ary’s 101:19; 102:16
18;38:12, 12, 15,21; 127:4,5; 130:13,18, 19; 136:16;137:11; 153:23;
155:4;1675, (5;17T2;
131:2;133:18,23; 134:15; 179:3,4; 185:15, 18; JWNrOifIbStiIMi 20:5
39:10, 22; 40:2,4,10, 14; 154:19;159:8,9, 10;
41:4,15, 21;43:5,22; 137:8,21, 23; 138:7,16, 189:5,15, 17; 198:13, 14; ~auge 66:3
16914, 14; 197:2~
45:13; 46:9; 47:19; 48:16, 18,25; 139:4,5,17, 24; 205:22;206:23; 207:7,13, ;ave 67:1,2,6,9; 118:24;
203:13, 17; 207:11
20; 49:7,22, 23; 53:16; 140:11,25; 141:3,7, 22; 15;209:14 [32:25; 149:14; 151:16
142:1;143:19; 144:20,22; four-month 154:25
54:12; 55:12,13, 17,21; Frost’s 14918; 193:24; ~ender 69:5
57:3;62:20; 68:3, 7; %:2, 145:11,19;146:14; fourth 25:24; 49:3 209:8 ~ena 16:23,24; 17:1
25;97:21; 110:20; 150:4, 147:11;14817,18 tOVeS33:12; 88:18 fruition 164:1.4
149:12,20,21; 150:1, 11; Jeneral 14:25;97:17;
20; 1701; 172:5, 13; Francisco 6:1z 95:1% full 6:24; 9:8, 13; 17:16; !01:8; 145:18; 149:7
173:10; 176:2; 179:10 151:3,6,6,7,8, 23; 152:2, 162:24
11,25; 153:1,5,7; 155:12, 22:11;72:17; 75:16 ~enerally 100:15
fomivirsen’s 15:8 frankly 133:7; 147:23; hliktime 23:10; 64:21;
22;156:24;157:17$17; 172:14 ]enerate 221; %.19
FONG 4:15, 15; 59:4, 15; 158:3,8; 159:19160:7, 137:9
Fred 56:6 Jenerated 27:6; 107:22;
60:17; 61:6; 91:23; 93:24, 12,15;161:9; 162:24,25; flli~ 19:21;64:20; 72:19; [23:6, 14,15, 25; 140:13
25;94:10; 104:12, 13; 163:9;164:14,17, 25; free 170:16,25; 173:7,7; 38:4; 146:7; 161:4;
105:7; 125:8, 15; 147:13, 208:2 Jeneretion 149:3
165:8,15,18, 22; 166:7,9, 170:18;195:1O
14; 148:3; 155:16, 19; Freemen’s 146:2 %eva 11:6
17;167:12,17, 20; 168:4, function 15:21; 17:8;
156:5,12, 24; 157:6,8; 17;170:i; 171:8,13, 20; Jentleman 67:19
frequency 18:17; 185:22;186:4; 206:14, 16;
159:7,9; 176:19,20; 172:9,16; 173:10;174:5; pographically 132:24
185:5,6; 188:20; 192:7,8, 120:16; 156:7; 169:24; 210:12
175:21;177:7;179:15; 172:12 fund 102:4 Jet 10:18, 21;23:20,20;
.—-. 22; 197:5,6; 201:23, 25; 182:22,23; 183:5;184:6, hquent 64:6 Fundamentally 110:19; }011; 32:6; 36:9; 45:7;
210:3,4
9, 11; 185:4,10,10, 23; frequent-fairly 64:1 172:6 57:24; 59:10;72:17, 19;
Food 14:2; 109:1 186:8,10,15,19, 22; 77:10;83:15; 84:7; 86:25;
for 5:17,18,21, 24;6:4, 5; 187:20,25; 188:6,9,15, frequently 20:6; 64:2; funding 6:25 39:2; 103:18; 109:23;
7:2;8:6,9, 11,12,14, 17, 18; 189:21,22; 190:1, 10; 99:14; 103:2, 2; 141:14 fundoscopic 108:11; 118:3; 119:4; 120:3;
21, 23;9:3,6, 23; 10:13, 191:2,3; 192:15;194:16; friends 10:5; 11:6 111:1,2 128:24; 130:14, 21; 137:2,
19;11:1,2,22; 12:1,12, 195:8; 1%:9, 14;197:19; from 4:17, 19; 5:23;6:16, fundus 25:11, 22; 26:20; 11,13, 22; 140:3; 142:13;
20, 25; 13:16,22, 25; 14:2, 199:12,20, 23; 200:3,10, 25; 7:8; 8:10 9:19; 10:7,8, 28:14; 33:18; 4,5:17; 143:13;152:5;154:5;
Miller Renmtimz C.nmnanv. Tnc (* 7\ 43. . . .
Opthaknic Drug8 Subcommittee of the
July 22,1998 Dermatologic and Opthalmic Drug Advisory Crete

155:12;1645?0;166:19, iood 6:15; 7:15; 13:24; Iappened 11:8; 30:24; 96:14,18, 18;97:6, 11,12,
_p- 357:24,24; 178:2; 4:18; 17:23; 181; 19:3; H )3:2; %:20; 126:12; 22,23;98:6,10, 18;99:1,
6; 193:5,8; 201:19; !3:8;56:13;63:12; 64:24; 144:16;169:10 9,12,13, 14; 100:10,14.
17;210:15 )3:15;112:8; 121:23; Iappening 17:22; 164:6; 15; 101:11,23; 102:8; ‘
WWRT 10:25;18:12,15,
>-.s 75:13; 130:16;210:7 24:20; 149:13; 156:12; 167:11 104:2,3,4,21, 24; 105:4,
16;19:8;59:16,18,21, 23;
.60:8; 161:14; 162:4; Iappens 65:5; 117:4, 5; 21;106:15,20; 107:2,9
getting 62:4,4,5, 5; iJ2, 12,14,15,17, 23;
.68:7, 19; 192:14; 195:18; ;1:19;95:20; 141:16; 120:17,19; 129:15; 155:8, 108:15,15, 17; 109:22;
124:1,2; 129:12;168:24
,99:23; 201:16 21 110:20,21; 111:7; 112:8;
give 38:21;49:15; 66:8; [62:23; 163:2
jot 9:16;75:14, 14;76:7; 115:19;116:6; 120:22;
70:11,16 ;84:12; 85:20; lad 7:11; 9:9, 19; 10.5, 5; 4appily 56:13
~8:3;106:12;128:8 121:23;122:6; 123:21,23;
93:23; 115:2;119:2; 11:21;25:4, 6; 26:24;27:3, happy 82:11 124:7;125:7,10,20, 23;
[34:16;145:22; 154:14;
122:1;138:9;155:3; Z3;28:18, 20; 29:10, 11; hard 7925; 143:16; 126:4;1271,10,12, 15;
[64:15;180:20; 199:22;
164:17;174:8;179:14; !02:23 }1:3;32:5;33:1O,13;34:3, 147:1;193:5 128:20;129:10,22; 1307;
183:9, 13;188:12;200:13, 7;35:2;36:18, 25;37:3; harder 164:8 132:9,17; 133:17; 134:11;
~otten 10:15;n:13; i2:13;43:7,7,8,14, 22;
14, 15;209:22 Zo7:12 harmful 178:23 137:5,5, 10,21; 138:20,
given 38:15; 39:9; 40:5; i4:19, 21;47:7; 50:3,18, 23,24; 140:4,13, 25;
Government 207:11 20,25;51:1,8;52:13,21; has 5:16, 21;6:4, 25;“7:1,
47:9; 49:17; 50:21; 53:6; 141:2,4,6,6,8, 11; 142:5,
yaded 42:14 54:1;57:25; 58:2,3,9, 11, 3,18, 24; 1015, 24; 11:2;
54:20;61:8; 70:3; 89:15; 13:1o,14; 18:2,5,8, 1!3, 22; 144:11,12, 17; 145:10;
grading 59:1; 105:18 21,23, 25; 59:4, 15;60:5;
113:21,23; 132:19; 142:1,
yanted 159:23 58:5;76:3,5,15,16,17, 16,24, 25; 19:5,22; 2Cl:25; 147:8,20; 148:9, 12;
1; 146:24; 191:22; 192:12; 22:23,24, 25; 23:17; 149:23;153:12; 156:21;
18,19;77:8, 22;83:10;
24:15;26:13,16, 17;33:2, 157:11,23; 161:9,11,14,
193:1; 1%:9 grants 6:25
3raph 74:14; 75:12;
?0:17, 18,20, 23;91:9,18, 16, 17; 162:1,12, 21,23;
giving 24:23 3,20;35:10 38:25; 55:17;
76:10
21;94:20,20, 22; l~22; 163:1, 11; 165:8; 167:25;
Glaucoma 52:10; 184:9; 103:17;104:1,5,13, 18; 57:3;60:1762:11, 19;
graphs 76:21 168:18;172:2; 173:16;
188:19 105:4;106:8;108:3, 14; $5:21;70:9, 22;73:12;
176:5,9; 177:2, 13;
glaucoma’s 52:10 grappling 179:20 10!211,14;112:2; 114:6, 74:2:77:14:81:22; 8320;
178:15;179:1,2,7, 22;
Glaxo 167:13 greet 56:18; 118:3; 12, 14;115:14,23, 24; B4:l-, i/.~3, 25;86:1:3;
B7:2;88:4;93:9;%: 19; 180:6; 182:1,21; 18 :3,5,
go 10:14, 19; 11:4, 10; 149:1~ 173:11; 191:25; 116:1,1,12,22 ;118:8,11, 17; 184:2,4,20186: % , 18;
194:3 15,21; 119:13; 120:12; lol121; 103:7 107:7;
13:20; 14:22; 15:1,7, 17; 187:7; 188:12; 190:3,19,
peter 36:23; 37:l@ 122:6;126:8, 16; 128:20; 109:6, 12;112:1!+114:25;
93:21; 36:5; 49:8; 50:5;
43:7;161:10 131:4;132:7; 136:9; 116:3; 117:3, 12;121:.21; 19, 25; 191:1; 192:14;
62:25; 63:2, 10;65:12, 14; 193:2,7, 12; 195:23;
137:4; 139:8;140:4,5,5; 123:5; 125:18;126:2,7,8;
1%:23; 197:21; 198:10;
_7&19,21
—. ;71:13;72:7,7; Grillone 13:23,24, 25;
141:1%142:9,19143:18, 127:19130:19, 25;
15, 19;84:24; 85:25; 147:8; 148:16; 152:22 131:25;134:24; 136:22; 199:6,16, 23; 200:5,6, 21;
d; 87:3; 893; 90:9; grossly 177:18
19, 22; 144:1,2,4,7,8, 25; 201:5, 20;202:3, 11, 15;
145:10,14,15, 17;146:6; 149:5,8; 164:12;165:6,
, 100:14; 102:22; group27:3; 2910,24, 25; 11;167:7,9, 13;173:20; 204:23;205:4,14,15,16,
Lw4:21;106:9; 114:20; 149:13;150:13;151:20, 16,17,20206:6, 10;
30:3,7,9,10,16,18, 23; 25; 152:1, 1; 154:22,24; 175:25; 176:5,10,12,15,
130:4; 131:25; 134:25; 31:24,25; 32:2; 3613; 18; 180:12; 182:13; 207:2;208:lQ 209:9,19,
136:7; 137:6,11, 18; 155:1; 157:16,17,21,22, 20,22, 24; 210:9
46:3; 47:11, 14; 50:24; 23, 24; 158:5, 18;159:18; 183:24; 184:3;185:24;
145:7,7; 149:25;153:1; 52:25; 59:5, 6,8; 64:? 186:1; 187:11;188:18; haven’t 54:10; 58:16;
158:7;159:17;167:23; 161:12,22; 164:18;
68:5; 72:25; 73:4; 74:5,6, 165:16168:13, 15; 190:14;192:3; 194:1OI,21; 708; 92:20; 99:22;
168:24;172:19;173:18; 9; 77:1,2,17,17,19, 20; 198:11;200:2; 204:4; 147:22;201:1
175:18;185:15;198:25; 169:25;170:3,4, 22; having 4:6; 101; 18:17;
78:4,23,23, 23; 79:18, 18; 171:1, 18; 175:2;177:13; 206:2; 208:8,20,21, 1!5;
199:10;201:13;207:4 &lll,ll,17,21,21 ;90:7; 2108,15 19:6;32:7; 35:6; 44:1, 15;
go-or 98:3 183:23; 191:19;193:7;
100:21,22; 102:22; has-it 62:7 46:14; 49:12; 63:24; 75:2;
195:16, 18;204:3 7914; 80:20 84:23;
God 175:19 104:15; 105:24,25; 107:4; hasn’t 92:22; 187:2
109:16; 1109; 117:2; had-1’ve 177:14 94:10; 101:18; 102:22;
goes 75:9, 12;86:21; hate 131:23
93:15; 131:6;181:17 123:12;129:15; 13013, had-they 76:3 117:15; 126:18, 23; 128:1,
18; 133:3,16, 16; 134:12, had-were 762 have 7:4,8,9,11, 14; 6; 140:14; 156:17; 190:15;
going 9:10; 12:13;15:3; 6:16;9:5, 12; 10:14; 11:1,
12; 141:23; 146:2; 150:8, hadn’t 114:16; 163:8 208:5
19:24;27:12, 13;38:20; 4,8,9, 10; 12:16,17, :19;
42:4; 50:11;52:16; 59:1O; B;154:23,23; 18924 ha3f9:6 10:12,17; 11:1; having-being 109:24
group’s 130:1
13:7,8; 15:22;18:20; 19:6,
61:25;64:12,14; 65:4; 33:16; 128:6 145:15; hazard 138:18,20,22,
15;20:14,15, 20;22:1;
70:1,2,6,18, 21;72:7; groups 2623; 27:1; 146:5 23; 147:6,9,11
23:22, 25; 24:2;25:4,5,6,
75:8;80:24;83:1, 3;84:9; 2%16,2q 34:12,16, 18; hamnwring lW 10 ~ 28:11; 33:5;36:7,20, hazardous 1%:2
87:1; 102:24;103:18; 35:19; 52:8, 16;78:7; 79:5; hand 91:21; 187:14; 21;4021; 44:24;45:9,10 heze42:14; 86:2, 11,20,
105:7;116:13;119:16; 8(X18;93:19 94:3; 116:54 188:17; 203:6,8, 17; 46:18;499, 18;50:3,20, 21,23
125:10;128:21; 131:24; 125:9; 133:7; 166:22; 204:23; 207:1920922 21; 51:4,6; 53:7,10, 1[6; he 6:4;22:17,18,21,24,
136:20,21, 22; 139:3,6, 189:24 54:5,14, 20;56:14,21,23, 25;26:13,16, 17;83:7, 8;
handle 118:13
16; 142:11;146:18;160:7; GS106 123:10 23;57:7,9, 12;59:10;
handling 65:22 95:1,6,7; 100:24; 117:24;
166:17;167:10, 16;173:5, guess 11:11;99:21; 60:3,12,16,19,2061:2, 122:4,7,9,10, 14;125:5,
9; 180:17, 19;181:19; hands 207:20,22
101:16; 102:7; 126:9; 17, 24;63:11, 14;64:’7,11, 6 131:19; 134:10,21;
182:12;185:15, 18; 136:15; 156:24;162:19; Hanks 9:23 12;65:5, 10,12,13,19, 149:5,20; 153:12; 154:14;
#9:13, 14; 192:3,12, 22; 185:8; 192:17;199:3; HANNUSH 12:2,2; 19, 2CX 67:5,11, 17;68:13, 164:1; 179:7;181:17;
2,3, 3,6; 194:7; 204:1 14812, 14; 151:10; 153:4, 13,15, 25;70:13, 24; 193:24
:13;199:24;202:24; 14,25; 176:11, 12; 181:10 72:10,10, 25;73:3,9, 22;
14;209:23, 24; 210:2, guess+r 157:18 he’d 107:12
guests 5:25 11; 184:1;185:22; 193:14, 75:3;76:6;78:6, 19;79:10,
.. 15; 195:2; 197:9,21; he’s 23:3; 149:20
21;81:7, 10;82:7,16,16,
going-it’s 58:18 guidance8:12 199:9;202:4, 5;203:22; head 65:6; 197:10;
22;83:7, 21;84:3, 15;
Goldstein 10:3; 174:1,2 guise 194:25 204:7; 209:4,5 86:17; 87:10, 14;88’5, 17; 21010
gone 100:14; 104:5; gut 1%:4 happen 19:8;60:5, 22; 89:4,8,16,20, 22;90:2; heeded 183:19
121:21 @)fS 59:17;94:12 .97:8:164:5:2102
, . 92:1;93:5,6, 15;94:;22; Health 4:18; 205:25
Opthalmic Drugs Subcommittee of the
Dermatologic and Opthalmic Drug Advisory Crete July 22, 1998
beer-21:16; 22:3; 101:7; 31:15,20; 48:10; 54:16; 150:21,22; 155:10; 157:6, 9,11,11,17,23, 25;98:4, 12,18,18, 19; 194:2,3,3,
103:12; 107:12; 112:17; 55:20;65:13;68:10; 8, 21; 1597; 162:18; 6,6,13, 16;99:1,4, 11,17, 6,9,9,10,21,22, 23;
113:1;121:25; 129:6; 137:12 166:13;174:7; 185:8, 14; 21; 100:1,5,1:3,14, 14, 195:4,7,13,19,20,22,
165:22; 172:25; 173:25; him 83:4; 107:11; 149:19, 189:19;190:12, 14; 16,16,17,17,18,24, 25; 23,24, 25; 1%:2, 11,11,
200:19; 204:24; 206:16 21 194:19;1%:10; 204:9; 101:1,5,7,10,,13, 16; 25; 197:1,2,4,6,21, 24;
heard 45:10; 46:9; 49:12; him-was 83:5 205:11;206:19;207:16 102:3,7,7,8,8,8,8,10, 198:7,8,10, 14,15, 17,
57:9;67:12; 73:9,16, 20; However 7:7; 186:9; 11,12,17, 19,21,24; l% 199:2,3,5,7,8,9,14,
himself 15:13
78:13; 80:7; 87:17; 88:5; 187:6199:8 103:5, 12; 104:13; 105:11, 15, 17; 200:6,21, 23;
92:20; 98:2; 103:23; hindsight 124:4 16, 17; 106:1, 1,3,3, 14;
huge 197:16 201:5,8,8,9,11, 19;
105:17; 106:2; 112:20; his 6:2; 9:21,21, 23; 107:12; 109:20; 110:13; 202:3,11,17, 19;203:5,6,
67:20; 91:23; 107:13; human 15:19; 16:1,7, 23;
114:25; 149:21; 163:6 112:19 113:13; 114:4,5, 12,14,16,17, 22;204:1,
109:19; 110:3; 122:11; 17:10,11,13, 17;39:7;
hearing 6:13; 15:10; 5,7,8,13, 18; 115:4,6,6, 1 18,19, 19;205:2,6,9,
131:19; 134:9; 139:6; 148:18;149:16;193:19 14,16,17, 19; 116:8, 16;
23:5; 80:23; 98:14; 99:25; 12,14,22, 24; 206:2,4,7,
149:5,22 humans 66:13, 16;67:2 117:16,22, 24; 118:7,17,
101:19; 128:12, 18; 12,20; 207:8,15, 16;
173:19; 1%:6; 21o:11 Hispanics 69:11 hundred 103:23; 104:1; 18,18,19,20,23, 25; 208:4,4,6,15,18,19, 25;
hearings 126:23 histopathologic 131:1 153:23 1194,12,13,:13,15,23, 209:2,7,11,15,15,18,
hurdles 186:4,12 23; 120:13,16,18,19,22, 19,21,22,23, 25; 210:2,
heevens 166:23 historical 180:9
hurt 125:11 23; 121:4,6, 1:[,13,13, 6,7,8,12,13,25
helix 16:11 history 27:20; 50:22; 14,23, 25; 122:5,5,12,
61:19; 120:1; 185:24 Hutchinson 56:6 I’d 4:2, 6,7; 9:2; 13:25;
help 139:3; 155:3; 181:19 12,23, 24; 123:6,9,9,14, 14:16; 23:7; 57:5, 14;63:1,
HIV6:21,23; 7:11; 8:14; hypotonous 43:9 17,24, 25; 124:4,5,6,7,8,
helpful 11:17;73:3; 14;99:24; 106:9; 108:14;
173:22;210:14 9:8; 15:3; 17:22; 18:5; Hypotony 52:4 9,10, 12,1% 125:3,5,5,8, 111:22; 112:22; 116:2;
19:7; 20:19; 56:18; 61:18; 12, 20; 126:9,9,14,18,
helping 23:23 129:6 136:8; 148:14,16,
64:11;69:15,19;92:20; 22,25, 25; 127:13,16,18,
hemorrhage 45:23; 46:1;
95:16,22, 25; 99:18;
I 24; 128:3,6,11,12,18,
17; 15015, 23; 155:5;
84:16”85:14 174:22; 175:1,22, 23;
137:9; 139:13; 14023, 23; 19; 125.>,8,12, 14,22,
her 114:4; 181:16 190:8; 198:20; 199:4;
151:16; 166:21; 191:25 16:24;9:4,5,7,8, 10,11, 23; 130:5,5,14, 21; 201:13; 20&l$; 207:2
here 6:14, 20;9:1,4,7, 9; HIV-positive 23:25 14,16,16,17,17, 19; 131:10,11, 17, 18,23;
11:12;14:19;15:18; I’ll 12:22; 14:25; 15:1,3,7,
,.- hoc 103:16 10:2,5,10,13,14,14,17, 132:9,10,12,13,14,16,
18:12;21:25;29:9;30:2; 18,18,19, 22; 11:4,8,9, 17; 134:2,4,14,16, 24; 9, 12; 19:16;49:1o, 20;
hold 39:4 83:4; 86:18; 89:24;
31:23;32:7;33:22;35:8; 10,11,11,12,13,13,14, 135:5,7; 136:14,15,16,
.—-. 38:3,7, 24; 39:2, 14; holds 16:1o; 161:13 107:11; 132:21; 189:17; “
16, 17,21; 12:10; 13:13, 18; 137:4,5,6,7,16,21,
41:23;42:6, 7; 46:2;47:9, Holland 26:8, 13;82:20, 13,19,2015:7, 15; 18:9; 22; 138:17,21, 21; 139:3, 190:10
13;50:14,15,16, 17;51:4, 22;83:4; 94:21, 25;95:6; 19:2;23:10,11,21, 22; 6,12, 25; 140:7, 10;141:3, h’n4:ll, 11,19,21, 22;
16;55:24;66:12;67:19; 100:21; 107:11, 14; 24:2,2,10,11, 20,24; 10; 143:7,9; 144:5,8, 21; 6:16, 17; 10:24;11:12,24,
74:14;78:7;79:1, 21; 109:24; 111:9, 23; 112:1, 26:22;2917,21;32:2, 14; 145:25; 146:10,16, 20; 24; 12:2;13:25; 15:24;
84:19;85:9,11, 14;86:4, 14,23,24; 113:4,7,10, 33:9;34:24;35:11; 38:23; 147:9,14, 22; 1[48:11,19, 24:23;27:13;38:20;
6,10,12,14,15,18, 24; 13,20; 114:22; 115:4; 39:19;40:11;41:11; 21; 149:3,8,15,18,19, 52:16;57:23, 24; 59:10;
87:5; 108:18,23, 25; 116:8; 118:17; 119:11; 42:12, 15;43:16, 18; 21,23,24, 24; 150:4,5, 6&22, 24;61:4;62:3, 4,5;
109:5,15,18, 23; 110:14, 120:11, 16; 121:3, 10; 44:17,24;46:6;47:24; 17,18, 18; 152:4,25; 64:8,14, 16;66:10;68:17,
16;118:18;124:14, 14; 122:9; 123:2,23; 124:8; 48:4,9, 14;51:14,15, 22; 153:14,25; 154:1)4, 25; 24;69:25; 70:2;72:7;80:6;
125:25;127:19;128:10, 125:6; 127:4,6; 1304,5; 52:12, 20;53:22; 54:10, 155:10; 156:10,24, 24; 82:11,11, 15;84:9; 87:8,
19;134:23;135:2,7; 131:16; 149:8 20, 22; 55:14, 25; %:4, 5, 157:14,16, 18;158:12,13, 18;88:6,8; 92:21;93:11;
13618; 143:12, 18; Holland’s 77: 1,2; 107:4; 6,10, 15;57:7;58:6,16, 15; 159:18;16&19,20; 95:24; 99:3,25, 25;
150:25;154:19;155:6,25; 109:16,25; 111:12; 126:9; 20, 22; 59:4,6,7,14,15, 161:8,12,13,119,19; 100:13;101:5, 19; 105:3;
160:10,19; 170:8;173:24; 129:15; 130:1 15,25, 25;60:2,5,12,15, 162:7,7,11,18, 19; 164:1, 106:17; 117:15;124:1, 1,
177:3;181:15, 17; 184:2, Holland-between 82:20 16;61:13, 24;63:2,10, 15; 3,4,8,9, 23; 165:21,23; 2,6, 16; 125:16;126:19;
5; 187:2;188:24;189:2; %:3, 4,7,15,20,20, 22; 167:6; 168:2,5,7,9,14, 127:11,24; 128:4, 12;
look 101:4 129:13;131:21,24; 134:4,
199:11;200:18;201:9; ;5:3, 5, 14;66:12, 14, 17, 15,22,23, 23; 169:6,8,
202:21;203:23;205:14; looked 10:2 23;135:4;136:13; 137:9;
~7,17;67:ll, 11,12,13, 10;170:1; 171:22;172:5;
206:21;207:8;209:13; lope 55:7; 72:16; 117:22; ~9,21,22;68:18, 23;69:1, 173:13,21; 1744:1,1,2,3, 138:12;139:2,9,11;
210:1,10 [89:22, 24 1,23;70:8,9,18,20 5,9, 13, 16,20, 22; 175:8, 146:6;150:2; 154:9;
Here’s 28:17;29:23; lopefuliy 15:21 ?1:13;72:7,8; 73:22;74:4, 11,13; 176:4,5,7,8,9,12, 155:1;156:13; 158:20;
35:16; 51:3;52:1 lopes 8:20 11,16;75:$, 18;76:1, 3,4, 15,15,17,20,22, 23; 160:2,17;161:4; 162:12;
J, 14,15,16,17,17,19, 177:2,6,22,23,23, 24; 164:19,23; 165:1;169:1,
here-if 57:23 lorse 199:11
lx 77:3, 22;78:5;79:7, 178:4,6,7,8,1.4,14,15, 3;170:24; 173:1,2; 177:9,
here-Wiley 202:17 +OSpitSi 12:3 17,18; 178:7,9, 17;
10,11,21,21,24 ;80:18, 25;179:1,2,10,13,13,
hesitancy 176:8; 179:21 Iour 65:12; 136:17 23,25;81:1, 14;82:15, 16, 20,21, 22; 180:1,3,16, 180:20,20; 181:3; 185:8,
Hickman 186:17 tours 9:24; 10:23; 21,22,25 ;83:1,2,3,5, 11, 20;181:8,11,:11, 13,25; 11,13,15, 18;191:24;
high 18:7;20:9; 47:25; 137:11;157:10 [1, 13,14,17, 18;84:23; 182:11,15,21,24 ;183:1, 192:16;1%:6; 197:24;
54:9; 58:17; 78:4; 144:17, 10W8:1, 12; 12:17;30:11; 35:3;86:19;87:10, 13,14, 48,10, 12,22; 184:1,4, 198:4;199:10, 10;200:21;
18; 163:22; 169:23 )6:9; 49:18; 51:17;62:2, 6; 19,19, 25;88:4,12,20, 14,16,17,19, 21; 185:2, 201:1;206:1,15, 17;
.-.
highdose 105:24 ;3:8, 12;66:15, 22; 67:12, 22,25;89:4,5,8,9,12,15, },6,7,9, 11,1:3,14,17, 207:13;210:10,10, 11
z2,24; 70:2; 84:9; 86:20; 20,21;90:1, 14,17,19, 20,21,22,23, 25; 186:22; I’ve47:8; 48:8;56:21;
higher 32:13;36:22;
18:9,14; 90:11; 92:24; 20,22,23,23, 24;91:1,3, 187:14,20,24; 188:1,4,7, 65:20;71:19; 100:20;
W&l 79:14, 17; 165:17; 125:15;130:17; 137:4;
)3:16, 19;94:18; 99:20; i, 7,7,9,17, 21;92:6,9, 3,9,12,17, 20; 189:2,3,5,
[03:15,22; 112:20; 15,18;93:7,10,16,19, 5,7,8, 17,21, :23;190:2,9, 149:12,13,17, 18,21;
higherdose 45:8 [13:20; 115:2,6,7; 116:6, 175:2;177:16; 185:7; .
19,20;94:1,4,4, 5,6,19, 12,13,18,19,20,21,23,
highest 32:17; 58:13, 14; 7;118:13; 119:14; 120:14; 24,24;95:1,3,4,5,9, 12, 23;191:3,7,16, 17,20, 189:8;201:25; 205:23,23;
176:21 [31:10,18, 19; 138:11; 13,14,15, 17;%:6, 10, 20,24; 192:1,8,9,11,13, 206:16
highly 7:6; 18:1; 29:7, 25; [40:3; 146:7; 147:1; 14,16,17, 24;97:2,3,3,5, 17,17, 22; 193:1,1,4,6,8, I+xcuse 66:7

(1 <) h-.. T -w-.=-
Opthalmic Drugs Subcommittee of the
July 22, 1998 Dermatologic and OpthalmiC Drug Advisory Crete

iceberg 54:22 Immunodeficiency 71:2 20;37:1, 1,9,11, 17,25; 138:8,10,13,13,15,16, 6,15; 49:21;51:21; 52:2,
i@aqB4:12; 116:6; 164:20 immunosuppressed 38:7,7,10,13,17,24, 25; 19,19, 24; 139:12,19,20, 5; 53:5,8, 25; 54:1;88:5;
23:17; 182:14 56:8 39:1,5,7,16,21, 23;40:2, 21; 140:9,17,18,18,19, 163:21;167:19; 193:4;
Impact 31:9; 32:3; 3617; 4,5,7,9,9,14, 21;41:6, 24; 141:3,5,17,23, 25; 197:10
iiy 195:13
60:1;75:3; 88:21; 147:24; 11,14,17,18,22, 25; 142:4,9,14,15,22, 25; incidence 49:16
!Ueas 115:2 42:14, 17;43:15,18,20, 143:6,15,18, 20; 144:4,9,
180:13 inciude 40:15; 103:19;
identical 16:10;28:24; 21,24; 44:3,5,21 ;45:8, 11,13,18, 25; 145:2,4,5,
impacts 95:16 181:1; 191:19
108:3;132:23 11,13,14,17, 21;46:4,8, 10,10,12,18,20146:12,
identified 108:10; impinging 56:25 21,24, 24; 147:11,15, 17; included 25:16; 37:13;
9,9,16,22, 24;47:5,12,
110:19;114:2. 11; 118:21; impiant 1010; 19:15, 17; 148:6,7; 149:2,4,6,7,10, 38:5; 78:22; 169:6; 179:7
15,15, 23;48:1, 2,8,9,13,
169:14 74:1;98:24;102:11; 15,18,22; 49:1,11,21, 17,23; 150:6,7,8; 151:15, includes 19:19; 26:4, 23;
identify 116:14;117:16; 125:23; 149:14; 167:24; 23, 25; 50:1,10, 25; 51:6, 17, 21; 152:4,8,15, 17’; 35:5; 45:4; 50:7; 69:11;
118:23;142:6 168:13; 182:24; 186:20 6,15,17, 24; 52:1,3, 11; 153:2, 16;154:2; 155:!),9, 99:9; 155:16
identifying 117:5,14, 20; 190:1; 197:11 53:3,14,15,18,20, 24; 10,14, 15;156:7,21, 25; including 21:3; 23:23;
119:18;120:24; 147:15 implants 1921; 34:7; 54:13,15,18,23, 25; 55:3, 157:9,10,23, 25; 158:3, 66:24; 76:2; 92:4; 153:22
39:8; 184:25; 197:12,19 5,12,13,14,16, 19,20; 10, 15,22; 1591,4,6,23, ifICiUSiOII85:9
identify ing-eventuaiiy 24; 160:3,11,12,15, 2!4,
119:17 implication 70:5; 162:10 56:7,10,11,15,18,24, inconsistency 135:3
24, 25; 57:4;58:1;59:5,5, 25; 161:1,6,7,7,13,14,
if4:9; 12:8; 13:17;34:9; Implied 58:1; %:4 15; 162:2,17,21, 21,25; inconsistent 126:12
43:1; 44:8; 53:5,8, 24; 6,7,8,9,11,20,22, 23;
implies 181:5 fi15, 14;61:1,2,9, 10,19, 163:3,3,8,14, 25; 164:7; incorporated 201:12
56:21;60:18; 61:6; 63:2, 3;imply 148:9 165:4,4, 24; 166:4,10,16, incorrect 158:15
65:21;66:9, 17;68:24; 22;62:18, 20;63:10,19,
import 106:17 22;64:11,13, 22;65:3,5, 22,23,24, 25; 167:9,16, increase 8:15; 143:2q
70:8, 11;76:5; 79:7; 81:20; 17, 21; 168:1,7, 18; 169:3,
82:1, 22;83:5, 11, 14; importance 61:13; 7,9,11,11, 12,16,20,22; 144:6,12, 13; 172:21
6,6,9,14,15,18, 19,2!1,
85:3, 25;88:17;90:9,17, 95:14; 169:18 66:11,18,19, 23;67:2,4, increased 43:3,11, 17;
23;170:6,9,14,19, 23;
22, 23;91:1, 3,6; 95:5, 6; important 8:18; 15:17; 7,7,20,23; 68:1,1,3,4, 44:5; 52:6; 70:6; 162:10,
171:3,7.8,9, LL 14,15,
%:24; 98:12, 16;99:8; 17:21;49:12, 19; 5,”:4; 15;69:4,9, 19;70:4,4, 21; 22,23,25, k;; 172:2,2!,7, 14; 193:4
102:14;103:9;104:1, 14; 62:8,9; 63:8; 79:12; 102:6;71:2,8; 72:13, 17,19, 23; B,10,12,12, 21; 173:10, increases 48:1,9 ~
105:7;106:18;111:23; 124:8; 131:8; 133:25; 73:1,3,4, 13;74:4,5,5, 11; 174:9; 175:4,4,6, 17; increasing 18:17, 25;
114:11;115:14,15,17,21, 142:? 148:2; 165:22; 24, 25;75:1, 5,6,8,10,10, 176:6;177:15,17, 18;
22;76:17; 77:25; 78:6,7, 19:1,23; 167:20
~22; 118:5,8,10,13,20, 175:14; 193:8; 197:3; 178:12,20,20, 24; 179:6,
22, 23;798,15, 1~ 8&2, incredible 149:5; 168:4
25; 121:15,19 124:9; 198:24;204:10 9,23, 24; 18&5,7,8, 14,
10,11,17,20, 25;81:5,7, incredibly 168:3
__~L 3,3;6,8, 17; 126:3, importantly 17:16; 21,23, 24; 181:16,25;
27:25:128:5.22: 7,9,11,15,16, 24;82:9, 182:6,12, 23; 183:4,11, independent 93:2;
2020; 21:7; 23:3; 50:2
7, 10;i33:5; i34;2, 14,19, 23;83:4,5,6,9,10, 17, 18; 184:6,18, 19,21, 95:22; 101:23; 102:5;
impossible 119:24; 15,22,23, 25;85:9,10, 121:8, 12; 148:10; 155:15;
.37:22; 138:21; 23; 185:2,10, 21; 186:5,
173:13 24;86:9;879, 19;88:7, 189:24
I>Y21; 143:5, 12; 146:13; 11,12,20,23, 24; 187:6,
149:1; 150:3, 16; 153:9, impressed 139:11; 14, 15;89:16,17, 18;9Ck7, independently 95:16;
14918 9,10,11, 19,20,21;
11;154:4;155:8,20; 11;91:11,16,21; 92:3,9, 188:20,25; 189:3,11,18, %1; 139:19
162:13;169:8,24; 1708; mpmSSiOn 97:12; 17,19,22, 24;93:2; 94:2, 19,21, 23; 190:5,7, 15, indicate 54:8; 123:17
173:2,3,24; 174:1,22; 117:23,25; 121:14; 12;95:2, 3,4,13,15,17, 21, 25; 191:4,18,22, 25;
20,21 ;%:2,4, 10,11,12, indicated 32:23; 60:10;
175:10,19;178:16; 173:21; 183:9,14 192:1,4,23; 193:11, 11;
15,21,21,23, 24;97:4,4, 71:1; 134:24; 165:5
179:17, 18;180:7,22; impressions 117:24 195:4,14, 25; 1%:4;
181:14,16;183:13;185:1, 5,7,14,20, 21;98:2,11, indicates 30:19; 43:21;
impressive 36:7 197:1,11,12,17,21; 54:18
9; 186:7;187:9;189:7; 13,16,17,20, 22;99:15, 198:23;199:5,11,15,15,
improve 101:24 17,18, 20; l(X19,18,23, indicating 3614; 37:19
191:7;193:7,8; 194:15; 19;200:1,7,8, 1620]1:6,
197:3;198:10;199:21; improved 124:4; 156:19 23,24, 25; 101:4,5,6,7, indication 18:9; 26:2;
190:19 12;202:14; 203:2,4,6,9,
200:12;201:14, 19; 23; 102:23;103:6;104:8, 11, 15,24; 204:2,8,9,18, 35:22; 36:9; 70:24; 89:16,
203:17;205:18;206:11, in 5:17, 19;6:7,16, 23; 17;105:18,23, 24; 106:11, 20;205:5, 12;206:3, 5+5, 21; 165:25; 166:11;
18;207:19, 23;209:2,11, 7:3,4,5,22,23, 24;8:7,8, 11; 107:7,11,15, 18; 7, 10,10,17, 18;207:5,6; 202:14; 203:1;210:21
13;210:7, 14,21 10,10,13, 13;99,17,22, 108:8,8,9,17, 17,20,21, 208:1,9,13,13,20, 2), indications 8:13; 61:3;
ignore 164:10;182:8 23, 25; 10:11,15,17, 23; 25; 10!X1,2,4,9,10,17, 24;2095,7,11,13,18, 200:13
11:7,9,15,21 ;12:1,6,20; 21,22, 23; 1102,5,5,6,9, 20;21016
iiiad 123:10 indketor 142:2
13:3,7, 17; 14:5;15:3,3, 12,13,14,16,18,18,23,
Illinois 103; 22:17; 174:3 6,19,22, 24; 16:1,3,7,17, 23,25; 111:1,4,12,13, in-vitro 408 individual 24:22; 30:20;
illustrating 122:14 18,21, 24; 17:8,11,13, 14;112:2,5,6,6,6,7, R inabiiity 13:3 32:12; 50:6; 73:21; 80:18;
imagine 107:18; 119:15; 22; 18:3,5,6,13,20, 22; 113:22;114:16115:5, 10; inaccurate 123:25 81:3; 101:1;102:9, 16;
160:9 191,4,4,5,16, 23; 20:4, 116:20,25,25, 25; 117:4, inactivated 109:12
104:23;112:5; 139:24;
8,9, 12;21:12, 15,16, 19; 5, 20; 118:9, 16;119:8,10, 143:11, 16; 199:13;200:4;
immediate 16:23;22:21; inactivating 171:18,20 204:21,25
28:3,8,17, 25; 29:10,11, 22:9;23:1,3,12,13,14, 11;1202,8,11,14,15, inactivation-end 144:8 inducting 27:19
25; 30:3,7,9, Id 31:7, 24; 14,19, 21; 24:7;25:3,7,9, 20,25; 121:7; 122:1,4,15,
13,14,16,17,19, 20; 16,20,22,23, 24; 123:3, inactive 116:23; 144:8 induction 28:18; 33:25;
32:2, 20; 59:5;74:5, 6;
77:16, 17; 108:16; 109:17; 26:3,10,16,17,23, 23; 7,9,11,12,20,21; inadequately 1202 34:3; 49:2; 133:22;
J 10:9; 194:8 27:1,5,13,16,18, 25; 124:10,12,17, 25; 125:13, inadvertently 7610 139:16; 165:19
K!ciiateiy 31:24;
28:1,7,16,20, 24;29:2,5, 18, 23; 126:1,4,6,11,18, inappropriate 186:20 induige 181:15
18
11,15, 22;30:2,6,9,10, 22; 127:15,25; 128:1,14, inappropriately 109:9 industry 8:10; 186:10;
11,12,13,13,16,16,16, 16; 129:3,22; 1309, 25; 187:18
,mmse 193:20 17,21; 31:6,7, 10,25; 132:13,15,16,22, 24; incentive 9:5; 186:9
immune 68:9; 95:19; 32:3,5,8,20, 21; 33:10, 133:2,3,9, 18,23; 134:5, incentives 9:5 inevitable 111:18;
190:18;191:1; 208:11 25, 25;34:6,7,10,11,16, 5,7,9,10,12,12,19,19, incidence 8:14; 18:6; 112:11
immuno-restorative 22. 24;35:1,4. 12.16.19. 20,22, 25; 135:3;136:9, 30:8;35:24;41:6, 24; infacted 130:11
180:8 20; 36;2, 3,i,6,13,15,19, 20:137:6.9.9.11.18:
. . .. , 42:22; 45:14,23, 25;47:3, infection 19:20;30:21;

icebera - infeetion (16) Min-u-sel’iQt@ Millm lRPTwbrt#mu Cnrnnzsiw 1.0
Opthahnic Drugs Subcommittee of the
Dermatologic and Opt.hahnic Drug A&kory Crete Jdy 22, 1998

32:2436:10 0:5, 6; 47:5; 63:8, 18; nterfece 117:18 nveatigation 28:15; 3:20;84:1,4,9, 10,15,
infections 7:5, 13;8:8, i4:4;66:23; 136:18, 19; nterfere 61:21 )3:19 172:4 9,25, 25;85:4,5,5,6,9,
15; 18.7; 19:4; 20:6, 6; 57:1, 5; 174:8, 18; 189:25 nterim 29:7; 77:12, 13; nveetigetions 12:14 4,14,17,23, 23;86:1,5,
23:15;29:2;49:21; 55:25; njections 25:7; 27:24; ‘8:20; 80:8; 133:13; nvestigetor 44:11; ,12,14,15, 15,21;87:1,
63:25; 65:16; 139:20 !8:19, 20; 3020; 33:14, .66:7; 168:12 i8:14; 108:10 I,
15,20; 88:5, 15,16;
infectious 24:l;61:ll, !4, 25; 34:5; 38:15; 41:13; 0:9;92:16, 16;93:1 1;
nterin+protocoi 166:6 nveetigator?) 109:4;
20; 63:22 i3:5; 45:25; 49:4; 50:3,6; 5:2,3,22;97:6,18,20,
nternist 61:20 .11:14
i3:16; 64:1; 65:18, 24; 5;98:22,24, 25; 9%19,
inflammation 23:14; nterpoiatad 35:21; nvestigetor-mut tipie 0100:1,6,17,19,19,
k5:2,13, 18;67:4; 88:1,2;
42:9,17, 21;44:15; 48:1, .60:14 L1O:24 0,25; 101:2,5,6,8,15,
12,13, 17; 51:25;60:8; .37:4, 13; 150:7,9 157:3;
.67:25; 173:22; 194:17 nterpret 93:17; 112:3; nveetigators 27:11; 7,20;102:9,10,20, 24;
66:23; 67:8; 198:9 [0:12; 41:3, 16;42:11; 03:2,4,9,14,15, 22;
njactions-to 136:15 [38:11; 190:15
inflammations 63:25 i4:lQ 48:14, 15;61:1Q 04:8,18; 105:9,20,23,
nput 13:13, 16;89:9 nterpretebie 109:16
inflammatory 63:22 n3; 9m6; 108:6; 110:24; 5;106:3,3, 21;107:3,13,
nsect 141:11 nterpretetion 94:12, 14; [12:9; 12022, 24; 174:4
Inform 6:16, 19,21, 25; [08:22; 109:19,22;
4;108:14, 19; 110:10, 11;
nsert-correct 126:19 nvita 14:16; 106:10 11:4,18,19; 112:11, 11,
7:18; 8:20 111:19;112:5; 124:3;
nsist 205:18 nvited 5:25 :1;
114:21; 115:5, 14;
information 5:15; 6:19, [2925; 1301; 19&16
22; 11:25; 16:3; 22:2; netence 107:15 nvoive 5:20; 193:21; 16:18, 22;117:5,11, 23;
nterpretetions 105:22; 19:6;122:1; 123:2, 2,6;
24:10;33:5; 70:9, 20; neteed 11:16; 201:18 195:19,21
[10:5; 11915 24:5,7, 15;125:5,6,9,
72:10,11, 19;73:2, 5,6; netitute 4:18; 22:20, 22; nvoived 15:19,25; 16:7;
nterpreting 190:21 2,15; 126:10, 15;127:24;
77:3; 892, 12;92:2; !6:9 ?3:1;284; 33::23;71:15;
103:13;118:3; 121:9; nstituted 46:14
nterrupt 24:20 28:12, 18;129:10,11, 18,
36:2;134:2;209:11 9,21, 25;130:7,14,17,
123:11;124:9 132:14; nterrupting 25:1
nstitutes 4:18 nvoivement 5:23; 6:9; :5;131:6,8,11,11,21
134:4;137:22;141:1,2,9; nstructed 173:15 ntervai 37:8; 39:11; 52:2; }3:13; 34:15; 317:14
143:4, 1~”151:16;158:25; [15:18 !2,
22;132:4,4,4,15,16
nstructions 173:9 nvolves 27:19 7;133:2,4,13,14, 23;
162:2, 12; 163 11; 164:5; ntervals 21:6,6; 27:8
168:25;169:2,4; 172:15; nstrumentei 26:16 }0:5; 35:18; 40:18, 25; nvolving 26:15 34:6,13, 21+35:4;
173:17; 183:1O;188:6; nsufficiency 20:4 i9:14; 51:13; 54:8; 100:7, nvolving-netxt 33:7 36:4,13,15,17,19,19
207:7 nsufficient 91:1; 128:13 7 RE-epprovsd 166:2o
!4,
25;137:1,12, 24;
38:12, 16;139:11;
information-the 141:10 nsurance 9:14; 186:10; ntervening 13:3 ronicaiiy 11:15 4017; 142:14; 143:14;“
informative 195:14 187:18 ntimetely 23:1 rrevarsibie 54:25 45:2,2;146:7,8,8, 18;
informativeness 140:1 nsurers 194:14,18 into 4:8; 13:15; 15:2; IS4:3,8; 5:12,25 ;6:13, 47:11, 18;148:19, 21;
informed 56:22 ntact 87:4 17:21;28:24; 35:12; 14,16, 18,21 ;7:20; 8:18, 50:10,11,20,21,24, 25;
infrequently 21:7 nteger 209:7 }8:23; 40:6; 51:23;@12; 25;9:1,2,6; 10:16; 11:3, 52:4,24, 24;153:8,15,
infusion 19:14 integrated 22:2, 2; 24:3, 77:9;92:l~ 1O(Y1O; 12,12, 17; 12:5,14,22, .5,15,16,17, 20;154:1,
4;27:14; 38:4; 4011, 14; 107:5;124:2,2; 127:1; 23;13:11,22, :24;14:9,11, !,
15; 155:21, 23;156:13,
inhibit-based 18:2 136:16,21,22, 25; 143:22; 20;15:8,15, 2!5;16:3,7, .6,20;157:18,20, 22;
160:10
inhibition 17:1 144:1,2; 145:15;149:1; 10,13,15,20, 21,24; .58:13,14;159:1; 160:11,
Integrating 40:22
inhibitor 29:19; 31:12, 158:7,17,18 161:10; 17:1,3,5,10,113,18,21, !2,25;161:2,4,8, 18, 22;
13;32:25; 34:19; 37:13; intend 173:1o 165:8;166:19; 167:23; 25;18:1,14,2’5,25; 19:7, [62:10,15,17, 19; 163:19,
60:3; 92:3, 4; 137:24; Intended 77:11 168:2;172:4;173:18; 18,24; 208; 21:2,5,8,14, !2,24;164:1,4, 6,7,8,9;
138:8, 15; 141:13,18,20 intense 116:13 18Ck23;189:20,22; 14, 16;22:8,8,10,15, 21; 165:5,9,11,18, 22;
142:2,7, 16; 143:2,2; intensities 44:1 193:22;1%:11;201:12; 24:12,12, 13; 27:6,13,17, 166:15,16; 167:8,8, 10;
146:25
intensity 23:22; 41:25; 205:1;210:16 17;29:6,6,13, 20;30:7,8; [68:6,6,19, 24;170:3, 12;
inhibitor-based 140:14 44:3;46:4, 24; 47:23; into-you 171:14 31:12,23; 32:20,22, 24; 171:8,10;172:7,10,13,
inhibitors 7:9; 17:18; 4818; 55:15$111:25; intolerance 18:16; 33:7, 22;34:13, 14;35:8, 16,24;173:4, 24;174:2,7,
18:14,24; 19:13; 20:3,8, 159:24; 1~4, 18 202:15; 203:5 23;367; 37:6,20,21, 22; T,10,14,16,17,18, 23;
21; 21:10; 31:9, 16; 36:4; 38:3,6,10,11,17,21, 22; 175:10,11,17,19, 25;
intensive 21:22, 22; 27:% intolerant 7:9; 56:20 176:21; 177:1Q 178:12,
92:10,12, 14; 140:22; 39:1,2,7,12,13, 18;402,
33:15,16, 23; 34:2; 35:9; intraocular 29:2; 43:4,5, 3,5,10,11, 17’;41:4,5,6, 20,21,22;179:9,10, 11;
141:15; 142:9; 147:10,15, 37:23, 24; 38:8,16, 17; 11, 17;44:5;48:10, 11;
18,21, 24; 148:4,7,10 13,23, 24;42:5,9,10, 15; 1~1,2,4,7, 21;181:5,9,
42:7,7,24, 24; 44:23; 52:7;63:24, 25; 1%3; 43:17;44:17; 45:2, 6; 46:2; 19,20,24, 24;182:3,6,7,
161:17 45:7, 15;46:12; 49:24, 25; 198:9,10 47:9,9,13,19,21, 21; 21;183:9,16, 24;184:7,
irritiai 71:25;77:9; 55:16; 133:20,24 intravenous 19:14; 48:20; 49:2,11, 18;50:16, 11,12,14, 16; 185:7, 22;
107:10; 108:22; 113:25; intensively 208:22 165:1~ 194:17 186:3,4,6,8,14,18,1
21; 51:16, 16;52:3;53:5,
114:5; 121:4, 14; 162:5; 6,8,9,11,17,18,18, 25; 20;187:1,16,17,18, 25;
intent 133:15 intravenously 35:5
164:13; 169:12 54:5,11,12, 19,22,23; 188:1,9,21, 25;189:9, 10;
intention 26:22; 29:12, intravitreei 21:5; 25:7;
initiaiiy 132:1; 141:15; 55:1,5,7,13,20,22,22, 190:9,16, 18; 191:14, 25;
23 2625; 27:24; 33:24; 34:1,
170:9 24; 56:15;57:3; 58:1,22, 192:2,9;193:9,18, 20;
interactions 12:16 5; 38:15; 39:9; 40:5; 41:13
Initiaity-iet’s 170:8 45:25; 47:5; 53:16; 54:15; 25;59:8, 25;60:1,13,19, 194:1,6,7,23,24, 25;
interesi 5:9, 12,19, 22; 20;62:1, 1,1,7,9, 23; 196:8;197:11,15, 16;
initiated 59:16, 17; 65:18; 174:17; 176:2;
6:1,8,24; 11:9; 19:4;45:1; 63:8, 9;64:6, 15,18, 19; 198:1; 199:3,9,11, 24;
142:23 189:25; 190:1
46:7; 51:15; 62:16; 108:5, 66:2,4, 21;67’:20,23,24; 200:24; 201:6,8,9,11,1
initiating 144:9 8; 143:21 introduce 4:7; 11:22;
initiation 59:21; 171:10 68:9, 11;69:3,5,6, 23; 17; 202:20;203:2,9,23,
interestad 6&ll; 104:17; 136:11 25; 20415, 20; 205:6,8,
70:3,5,6,6, 25;71:12, 14;
injectable 176:2 107:18; 150:24; 173:2; introduction 14:10; 72:3, 12;73:3,4, 23;74:1, 14, 18;206:13, 16, 18;
injected 10:16; 136:25 183:17; 204:2,20 15:13;26:13 10,11,18,22, 23;75:11, 207:2,3,10, 25; 208:8,20,
injecting 63:11 interesting 121:25; introductory 12:9; 23, 24;77:2,6,20, 24; 22; 209:6,10,11,13, 23;
injection 10:15, 18, 21; 125:12; 194:13; 195:15 165:24 78:1,3,4, 6; 79:5,8,12, 210:1,2,9,11,14,14,23,
27:1;34:1;36:15; 39:9,25 interests 5:17 investigated 24:24 17;8&9, 20;81:1;82:13; 25

Milk=r Rennrt{fw C.nmnariv. Inc. Nlin-u-scrhm
Opthalmic Drugs Subcommittee of the
JulY 22, 1998 Dermatologic and Opthalmic Drug Advi80ry Crete

is-as 185:6.- 144:19; 145:17; 146:11, 185:25;208:13,23 129:13;131:1,2,18;
~*160:21 11,18, 19; 147:9,16, 16; itsalf 16:8,2q 17:3;42:2; K 138:11,17; 139:9;140:7;
‘n 155:1; 178:19 148:3,4,9, 20; 150:19; 63:18; 98:21; 102:4, 5; 146:1, 10;147:1,3, 19;
153:8,9, 11; 154:25,25; 182:11; 188:23 Kdser 4:15 150:4,15,17,19, 24;
5:5;7:1; 9:4; 10:11;
155:1,4, 25; 157:4, 18; 155:20,20, 22; 157:16;
1,.42; 14:3, 11, 15;22:23; 159:11,12,21 ;160:11,21; IV9:23; 10:4,4; 19:16; Kaplan-Meier 29:23;
23:16; 119:2;122:13; 30:2; 35:8, 16;74:14;
158:12; 167:24; 170:2;
163:14; 164:7, 14; 165:17; 35:3;98:23, 23;99:9; 171:14; 173:2,6, 18;
127:19;165:6;174:4; 16&15, 18 167:8; 168:3, 102:11, 12; 125:22,22; 75:21; 77:24; 107:6;
194:19 111:5,6128:16 174:24; 17920; 180:7,9;
3,11,13,14, 17;169:22; 194:17 182:23; 183:7;185:9,10,
isn’t64:17, 18;91:13; 170:22;171:5; 172:2; Kapjan-Meier’s %:11 ‘
10,12,13, 14; 186:21;
101:21;124:20;146:18; 173:4,14, 25; 175:10,11, tirnOfSky 28:15; 33:20 191:3,7; 192:17,23, 23;
174:12,21 19176:4,15,17,18, 21; J ..—
keep 45:8; 592~ 61:1; 194:22;195:6, 16; 1%:24;
isolated 163:22 177:6,22,24,25, 25; 115:6; 131:23; 137:18;, 197:9; 198:10,11, 15;
isolates 163:17 178:1,1,1,2,2,2,11,21, Jabs 16?I 3 140:17; 160:11,24; 199:4, 19;204:8, 8;
23; 179:12; 180:3,4, 23; 179:18 205:23;206:19,21, 23;
issue 5:11;40:10; 52:4; Jack 57:20; 58:22; 149:4;
181:1,5, 2Q 182:13,21, 154:3,7; 156:11 keeping 68:16; 144:25 208:5;210:13,22
56:19;60:25; 62:13;
25; 183:3, 13; 184:3,8,14, kept 158:25
68:11;71:21; 103:22; Jack’s 154:13 knowing 76:5; 104:17;
22; 185:13,14, 21; 186:1, Keukenhof 11:5
106:16; 115:5; 116:17, 18;
4; 187:1,17,17,18, 25; 119:25;120:1; 145:11;
Jacobson’s 95:18
119:14; 127:9; 129:1,4, 188:1,8; 1894; 190:7,20; Kevin 6:3; 11:24;134:24;170:5;204:21
15; 130:25;148:19; Jim 4:13; 62:25 149:18; 177:2; 193:10
191:10,20; 192:10, 13; knowledge 91:18;95:24;
150:16; 162:16; 176:23; 193:4,5,11,21, 25; 194:2, job 9:14, 21; H34:ld Kevin’s 119:12 149:9
183:2; 193:19; 195:25; 8,13, 22; 195:15,24; 187:2 key 15:11;16:24;22:7 knows 207:15
199:11;209:14 1%:10, 22; 197:2,2,3, 3; John 22:15 kdneys 10:6
issue-and 45:11; 83:18 199:12,20; 200:2,11,14, journal 185:10 KILPATRICK 4:13, 13;
issues 13:12;24:7; 53:3; 16;201:7,7,12,17,19, journals 26:18 24:2? ~~.“ ,57:12,14,17,
L
54:4;70:20;71:6,7,11, 21;203:2,3, 11;204:10, 22; 5w1o, 14, 17;63:1;
10,10,15, 22; 205:1,10, judged 41:25; 44:l;61:18
13,15, 15;93:8;%4; 8925; 901,8; 91:11, 16, label 22:11;24:14; 46:21;
106:14;115:4;146:16; 11;206:3, 13,14,15,20 judging 26:18 22; 99:23, 24; lW.5; 55:23,24;72:1, 22;73:10;
.149: 16;174:6 176:7,8; 208:19, 21; 209:2,15, 25; judging-would 122:6 101:3; 121:2, 3; 127:4;, ?0:4, 5; 1802; 205:8;
179:22;184:22;188:18, 210:7 132:7,9,21 ;133:14; 209:24
judgment 74:19, 21;
19; 189:2;197:7;198:23; tt’S 14:18; 15:16;18:9, 13; 134:1,18, 23; 155:5,8; labeled 42:12; 9&16;
84:5; 93:9; %:24; 171:5;
.--S22, 23;204:22;205:3> 19:3;21:2, 4; 45:11; 58:18; 175:16; 184:2, 18; 187:4 156:1,4; 158:13; 176::25; 194:10
38:11 59:25;65:2;69:17;73:24; 177:1, 5; 179:4; 185:16; labeling 203:24;204:9;
74:2Q 75:0 ~2, 22;78:6 judgments 81:13 191:12, 13; 19723, 24i;
O;8:18; 11:16; 13:6, 205:3,4; 206:2; 208:19;
7; 16:21;17:13;18:9;21:5; 79:2;80:24; 81:3,18, 25; Juks 26:9 1984; 202:6,7,19 2108,8
23:15;26:23;27:1;33:11; 82:5;8613; 89:21; 93:4; junior 56:4 Kilpetrick’s 94:1; 19):16 Iaboretoty 11:14;27:7;
35:5;36:20;37:6;38:6 94:20; %:6; 97:12;98:17;
jUSt 624; 9:3, 25; 12:11; kind 8622; 87% 92:9; iO:24;41:17, 18
39:17;40:12, 22;42:3, 12; 101:17;103:16; 104:3; 15:17; 19:16;32:3; 34:22; 103:13; 122:1, 10; 128:21 Ihck 73:7; 95:24
43:6, 15;44:7,9, 20; 105:5, 16;107:1; 111:19,
20, 21; 115:12; 117:3; 35:1~ 36:3; 383; 39:2(J kinds 140:6; 180:15; lag 116:21
45:13,16, 18;46:10, 20; 190:6; 198:22, 25; 199:2;
48:21;49:2, 19;51:17; 119:23; 12015; 122:2; 48:4; 52:16 58:2~ 596 landmarks 116:14
124:8,21, 24; 125:10 63:1; 67:4,11,12, 18; 204:22; 206:6
53:4,13,18, 25; 54:22; large 7:7; 24:13;44:2;
55:7;56:1;58:16;60:3; 126:3,11,22; 127:12,13; 69:25;7011; 71:5, 14, 15; Kisner 14:8,10,14,16, 46:3;81:16; 82:9;88:19;
61:6;62:1, 1,2,14,21, 23; 128:24;13011, 13,21; 72:7, 9; 78:10;79:6;81:12, 18;23:8;57:5,7; 58:20; 121:16, 16; 151:15;161:7;
63:4,9,11, 16;64:5,6, 14; 131:16;132:5; 135:6; 16 83:25; 84:22;86:25; 59:10;62:7;63:6, 13; 164:7;178:20; 179:23;
65:13, 19;66:10, 25;67:2; 137:8;139:2,12, 14; 87:8;9&l; 91:23;93:19, 68:22, 25;693; 106:14; 200:9
6915; 70:25;71:21, 25; 143:10,16, 21; 146:18; 22, 25;95:2,11,12, 18; 119:6; 132:21;133:17’;
134:14,21; 135:5;138:1, largely 109:19
72:1,3, 24;73:1,3,3,9; 147:1,22; 153:10, 11; 99:5; 102:15; 105:15,16,
158:16;162:8,X 167:4,4; 4,6,12, 20; 139:2; 140:10; ‘argeat 166:16
74:23;75:2,13, 23;77:6, 16;10623; 108:13;
8,8,9, 10;78:1,1,13; 168:8,l% 170.a 171:9; 143:7,9; 146:15; 147:5,7, eat 9:15, 22; 10:13;
172:2,3,14,15, 15; 109:21; 110:13,23; 112:8, 22;148:9, 17;151:3, 13; ~8:10;22:19; 50:15,19,
79:6,7; 81:21;82:7,12, 25;113:20;114:10,23, 24;
14;83:19;85:6,6,12, 13; 173:13,19 17915; 152:23;153:5,20; 154:1, !4,25;51:5; 56:1;66:12;
116:5;118:7; 119:20,20; 13; 1563, 10; 158:16,,21; )1:24;87:6;99:5; 114:2;
86:13, 18;87:5; 88:16, 19; 180:10,11, 24; 181:18;
183:11,20185:2,13, 17; 120:7, 15;121:3; 124:6, 159:8,10 160:8; 162:1, 115:21,22; 116:10; 119:9;
93:10, 20;%:16; 97:4,4, [2623; 131:24; 1372;
6,7,14,14,14, 21;98:24, 186:8;188:21;189.18; 13; 125:16;126:14,22; 16;164:23; 165:3;167:7;
25;99:14,19, 22; 100:5; 192:8,12,16, 22; 194:3, 127:21; 131:3,12,19, 24; 169:8;172:24; 173:5,16, [40:12;150:19; 152:10,
102:4,7; 103:3,4,7,7,15, 24;195:25; 1%:2, 3; 136:8;137:18,23; 139:3; 19; 175:3,22 ~8;153:6,8,11, 11;157:8;
16,18, 23; 105:3;107:11, 1972; 199:24;201:9,16 145:19; 152:10; 155:5,22; knew 9:lT761Z [62:8,25; 163:3; 195:22
12;112:8, 12; 116:3; 206:8;20&14; 209:1; 157:14;159:9 162:12; 113:16114:5 ast-minute 172:18
117:10,11,25; 118:1,22; 210:19 164:11, 19; 167:6;168:5, know 23:19 54:24; 55:2; asting 44:7
119:1;120:5,19; 121:10, it’s-when 181:4 21; 173:2; 182:17;183:13; 56:23;60:17;61:6;64:8, ete6919; 151:7;166:4
_~_15, 17,23, 25; 122:17, it’s-you 93:3 184:25;188:4,9, 12; 15,15, 17;65:10; 67:13, etecomers 11:21
‘123:2,2; 124:10,20, it-did 178:23 189:5,7, 17; 192:16,18, 14,21, 24;68:18, 18;
21, 22; 193:15, 18; 194:3; etely 177:16
‘25:1,2,3,3,3,5,6,7; it-it 93:22 76:16;87:19; 92:15;93:7,
); 128:5; 129:5,22; 198:7, 16; 19!121;201:5, 16,19; 94:14;99:11,11, ‘hter 12:23;
66:10;
69:25;
iso:25; 131:3,6,8, 11; it-oh 11:11 19;202:20; 203:10; 11,22; 101:2,21, 24; 74:16; 83:6,
9;85:13;
87:4;
132:2,4; 133:1;136:19, it-was84:22 204:18, 23; 205:12, 22; 102:3; 104:15, 17;105:7, 38:8;95:6;118:10;
22; 137:5, 12;138:11; itS 8:2,3; 39:22; 44:14; 206:2,7,20, 20; 207:3; 9, 10;113:11,15, 17; 127:21; 158:6
141:5,19, 25; 142:4,5,13, 46:19;97:4; 106:17; 208:15;210:7 114:6,7; 124:4,6,6, 13, atter 70:5
14.14.22.24:143:18:
.,, —, 164:13:168:16:178:23:
-. iustify 49:7 16, 22; 125:3, 10; 127:25; mughter 65:1; 177:4;

is--as - Laughter (18) Min-u-scrilDtt9 Miller “RerKmthIQ C.nmnanv. Tmc
Opthalmic Drug8 Subcommittee of the
Dermatologic and Opthalmic Drug Advkory Crete J& 22,1998
204:2-7;207:1,17 53:4;
54:20;
151:3; listed 20:13; 25:6; 69:6; 1401; 1502; 156:13,24; make 6:20; 24:11; 38:23;
Lswande 6:14,15,16 178:10;
189:7;
196:17 71:19; 108:18; 198:8 175:2 49:20; 63:5; 66:4; 74:17;
lay 15:10 letting 137:11 listening 101:16 100kS 17:15;32:1; 55:24; 79:3; 83:11;84:10; 91:4;
layer 137:2 leVel 16:2; 19:4; 20:9; listings 107:21 117:11;131:3; 159:21 92:9; 93: 11;%:7, 11;98:7;
laying 136:17 40:15; 45:8; 52:14; 53:15; literally 155:25 losing 9:25; 10:1 99:6; 101:4; 102:8,14, 24;
109:13; 111:24; 112:3; 104:4, 16; 105:17; 111:5;
layout 51:4 lherStUre 920; 45:21; 10SS55:3; 134:23;
145:11; 170:9; 171:7; 170:14; 1%:19 115:18; 117:21; 124:15;
lead 20:6; 38:22; 72:4; 117:4; 120:12
176:5; 179:21, 25; 180:25; 127:8; 131:21,24; 142:25;
81:15;82:9, 20; 180:17 little 58:2~ 74:16; 79:1,6, lost 10:7;66:12
203:4; 208:24 144:15; 148:14,22, 24;
leader 13:25 80:24;84:7, 12;86:1, 1,9; lot45:10; 64:4,11 ;65:16; 149:9,23, 25; 158:16;
levels 19:23;41:8; 43:6
leading 33:1o 88:5; 92:11; 113:2; 126:6; 97:16 102:2’5;105:18 164:23; 167:6; 168:3;
lies 179:6,6; 206:9,12 132:14; 135:6; 154:5; 106:24; 112::20;123:4;
leakage 63:9; 6s:23: 173:14; 178:1; 181:1, 13;
1ife9:14, 15; 10:23; 11:14; 162:13; 177:23; 181:13, 146:16; 148:20; 149:14, 183:14; 184:1; 185:18;
66:1,5
20:18; 23:10, 12; 57:1, 1; 15; 194:8; 200:10; 201:17, 15; 164:12; 1’72:6;176:5; 187:3; 193:23; 194:7;
leaps %:7 64:22; 107:5,6; 137:8; 17;203:16 193:3; 195:8, 19; 203:24; 199:8;200:25; 204:15;
learn 124:7; 199:5 182:9; 188:19 208:20; 21o:1!6
live 915;64:22; 137:13; 206:6, 13; 207:9 208:19;
learned 56:21; 149:15, life-style 137:13 206:5 tots 11:6;41:18 210:7
19 Iifetinm 197:13 load 11:2;92:20; 93:6; love 61:14 makeup 64:15; 65:25;
learning 124:7 light 7:22; 82:24; 85:23; 95:13,14,16,19,23, 25; lover’s 9:21 ~: 18;69:3
least 17:13; 18:22; 26:25; 91:4; 116:13 %5; 139:18; 140:6,23; 10W9:9; 21:3; 41:6, 13; nekes 85:6; 100:24;
53:7,9; 54:6;61:2; 65:9, lightening 84:18 146:8
11; 107:25; 128:6; 129:5; 45:23, 25; 47:21, 21; 103:8
142:4, 14; 144:7,9; 145:5; lights 66:1 1;84:7 loada 93:1; 138:2; 139:7; 55:22;7916; 88:693: 1; Tlaking 18:21; 53:15;
14720; 148:5; 151:25; like 4:2, 6,7; 6:3; 9:3; 195:17 95:19; 142:19; 197:2 ;1:5; 86:13, 14; 93:8;
152:$$162:17; 189:9, 11; 11:22;12:6, 11; 13:25; local 20:16; 27:17; 40:2; Iowdose 105:24 122:18;135:4; 149:2;
202:’ ~“2r-:13; 209:25 14:16;15:16;23:7; 29:17; 41:5:62:23;71:1; 137:1; lower ‘7:7; 97:13; 164:1; !06:8, 12
least-l 177:7 f7:14; 55:24; 56:10; 57:8, 182:3;190:2;208:6 168:25; 169:3; 1%:20 Ilde 68:19;69:5
14,20; 59:19;60:7,20, 22; Iwete 192:3 Luckily 10:2 nalea 64:9 ‘
leave 117:22,24; 151:10, 51:6,21;63:1, 14;66:9;
11,24 58:18;81:12; 90:9;99:24; located 86:3 LUDWIG 5:6,6 nerrage 44:15
Ieevas 93:22; 146:11 ~04:21;106:9, 18;107:12; OCStiOfI 83:9, 10,20; lumps 51:19 nenagaeble 48:11;
IetWing 176:7 ~08:14;111:22; 112:16, 35:25;87:7; 8ik17; 132:15 Luncheon 135:9 37:8
led 111:9 z2;113:1,5; 116:13; OCatiOnS132:24 unchtime 135:7 nenaged 43:15;48:24;
left 4:9; 11:14, 14;42:5, ~17:ll; 122:3,3, 18; .Ong 9:24; 23:13, 13; @:16
12;51:7; 68:14;76:10 123:17;127:8; 129:2,6; ~~,ly 33:11; 35:10,20, nenagement 48:8; 57:4;
151:14,20,153:9, 10; [31:3;134:8;136:4,8, 19; ;0:3, 3; 60:7; 83:2; 91:6; il:18; 63:22; 65:6
154:17; 184:12 [40:3;146:5;147:16; [16:6, 21; 117:25; 119:14; nenager 137:10
!48:14,16, 17;149:24; [50:21, 22; 157:8; 160:15; U4:19 nenaging 68:2
Iegalty 173:7
[50:15;155:5;162:20; [6617; 185:24;207:10
legislation 172:22 *IISCUiat’45:2, 3; 52:17 nendatory 142:17
164:14;165:19;173:25; Iongterm 68:12; 110:20;
legitimate 100:19;194:2 174:22;175:1,22, 23; made 5:12; 6:1; 8:6; 13:5, nenipulation 107:7
144:16; 152:17 10, 14; 18:2,8,9; 22:1z
length 16:21;75:16; 178:6;17916; 189:24; nenner 95:1; 114:16;
longer 39:4; 50:10;77:3; 48:5;49:9; 74::20;81:3;
120:4;150:2,5,10, 24; 190:8;195:14; 197:1; [23:9 125:24
142:9; 152:1, 16; 15922; 94:18,23, 25; 95:1; 99:10,
153:17,20 198:23;199:4;200:6,12, TIenufacturing 71:6
166:11;181:13,20 12,13,14, 18; 100:24;
lens 43:21; 52:12 17;201:13;203:5, 6; nany 12:18; 20:7; 23:19,
206:18;207:2 longer-term 73:2 111:25; 120:22; 122:4;
Iasion 1016; 25:14; 126:4,7; 133:17; 141:25; 15;46:8; 50:3, 3; 51:17;
likelihood 54:18; 55:10; longest 150:10152:23
33:11; 117:6; 130:10; 142:17,21; 14!):5; 165:15; ;2:2; 70:3; 78:7; 79:15;
132:4; 143:22; 144:2,3,9; 155:21 look 24:6; 27:5; 28:3; )2:24; 115:6,7; 126:16;
16&3, & 16920, 2(3
145:1; 158:22 likely 37:6; 49:19; 703; 30:23;36:17; 38:4, 7; [39:17; 140:2,3, 11;
170:6; 175:12; 177:16;
116:21;119:23; 193:9 49:13,17; 5918, 23; [41:17,18; 142:15;159:7;
lesions 25:13; 83:21, 24; 204:13;206:2,11
52:21;67:2; 81:6; 85:7,8; !61:14,16; 162:18;
84:1,2,4, 19;85:11,15, limit 37:7; 49:13; 51:12; Madison 117:3, 12;
)2:6; 102:21; 134:2,8, 2(3 !66:13,23; 184:5; 188:25;
19;95:7; 12%9,10,12,17, 52:5,9; 54:7; 58:12,15 120:13; 123:15; 130:16,
141:16;142:1; 143:3; .90:4; 194:17
18,20; 144:1; 145:12,14 imitad 73:6; 98:19; 16
148:3;150:3, Id 154:15,
less 21:22; 34:2, 8; 35:9; 182:2 197:22;2@l13; Magnifketionl 85:5; 86:8
ll?lp 122:18
16;183:2; 188:9; 18921,
36:23, 24; 37:3, 24; 382, ~l@.9,11 nSpS 117:21,21
25;192:15; 193:13; magnitude 179:25;
8, 16;42:7, 24; 45:14; ine 55:3,4; 75:9, 12; 1%:10, 10; 199:16; 201:7 Mark 95:18; 146:23;
208:24
49:24; 55:16;72:9,10, 11; 78:1, 1; 105:25; 129:17, !03:2
ooked 25:20; 30:23; main 185:4
88:1; 105:16; 120:17, 17; ~9,19,25, 25; 130:1,2; nerket 204:11
)6:21; 40:17; 44:8; 45:16; 11’ISintain20:1:B;82:15;
130:7; 133:24; 161:12; [85:3 ;2:13, 17;65:5,8; 76:14, 137:12; 150:22 nerketed 188:6
182:14; 194:14, 16; inear 138:14 ZO;7$Y6;88:20; 90: 14; narrow 10:6;20:4
1%:20; 208:22; 210:25 ~intain$d 153:18;
ined 155:1 )1:17;94:21; %:10; nesked 25:11, 22; 26:10,
kSS-511 37:2 154:18
ines 7:4; 75:15; 157:11 108:5;121:14; 143:24; O;28:13;76:11, 22;
maintaining 61:14
__—_ iet 24:11;42:3; 50:12; ipid 18:19 [45:17; 146:24; 155:24; 07:15; 111:8; 113:8,18,
66:1; 68:22; 79:20; 83:4; [60:6; 183:24; 184:4; ‘tWintenanCe 27:19;
iquidating 9:14 ~()&12 8; 121:6
90:9; 101:3,3,4; 10s15; 28:20;34:1,4; 4[9:4;
107:11; 113:20; 123:20; .iSa 13:23, 24; 143:10; [33:22; 146:3; :[65:20 nsstered 65:19
ooking 13:16;24:5;
139:10; 158:16; 188:12; .52:19 nejor 64:12, 1’7;72:2; netched 114:12
)6:19;40:22; 59:6; 64:9;
206:23; 210:5 iSt 5911; 106:23; 107:22, ;7:1; 74:12; 81:4,9 87:5; ~06:l; 181:24; 201:6 naterial 177:15
let’$ 28:3; 31:8; 36:17; !4; 113:21, 23 19:9;91:13;92:21; 97:11; nejority 46:3: 143:14; nsterials 106:9
37:1; 38:11;40:10; 49:6; ist-that 107:24 .02:15; 138:25; 139:4, 5; [89:9; 1%:6, i2 I MATHEWS 4:22, 22;

Miller Reporthg Companv, Inc. Min-U-Scritstfm (1 q) T 2W9fld(= . K#A’I’’UlX’VC
Opthalmic Drugs Subcommittee of the
July 22, 1998 Dermatologic and Opthahnic Drug Advisory Crete

91:25;92:1, +5;95:13; 194:3, 15;203:3, 8; 208:6; mentioning 107:1 minimums 36:14 142:4;144:4; 146:16;
~O:13; 137:21;138:2,5, 210:8 message 78:5 minor 110:5 149:19;152:11; 156:17;
‘-7;139:(J,9; ;43:6, 8; meaning 153:16; 160:14; messenger 16:2,4,9, f?IinUhS 15:4;38:20; 157:14; 158:14; 159:1;
25; 148:6; 159:15 16, 203:4 17,22 7014, 14; 136:17 160:1;163:9; 164:4;
.61:21; 175:24; 1763, meaningful 110:18; 178:2;181:1, 19; 182:18;
4; 179:18,20; 181:3,8, 11; met 158:3 mirrors 155:25
142:2; 144:5,24 188:15,24, 25; 190:18;
190:17,23; 195:3,4; metabolizes 39:22 misconstrue 122:24 193:9;194:8, 18; 195:11;
200:19,21; 207:24;208:4; means 17:4;49:25; methodologkal 188:21 misinterpreted 117:10 1%:4; 199:4,4; 201:13,
209:8, 18;210:13 52:12;67:14;81:7; X5;
methodology 188:13 misinterpreting 117:6 25; 202:3,5
109:2; 150:5, 19; 152:16;
matter 51:17;64:24; methods 181:21 misleading 791; %:16 morning 6:15; 8:24;
178:9; 187:7
105:5;122:2;159:25, Meyers 167:12 13:24; 14:4,8, 18; 23:9;
meant 117:24; 119:13 misquote 83:5
160:4 162:5; 191:18
rrwasure 39:12; 50:19, mke 66:15 missed 49:18, 19;9;!:22;
maximal 20:18 Most 7:l@ 17:16; 18:22,
24, 25; %:1 mkrobial 44:22; 52:22 98:18; 99:1; 120:5,6;
Maximum 35:18; 152:13 25; 20:20; 21:7; 23:3; 41:8,
microbiologicaily 198:19;201:1
maximums 36:14; 50:2; measured 55:5;67:12 24; 42:7; 43:2, 20; 44:9;
52:23; 58:6 missing 175:9
152:18 mS8SUrSIIISIIt 137:24 54:6, 9; 6&20; 63:20, 24;
microgram 33:14;36:15; misunderstanding 64:3; 68:15; 80:6, 7; 83:24;
lllSy 6:10;8:9; 19:7,9; measurements 142:23;
38:15; 133:22; 170:22 141:4
20:6; 24:20; 28:11; 33:5; 143:1 87:21; 94:22; 104:4;
63:2; 65:19; 79:1; 81:18, micrograms 39:10, 10; misunderstood 169:8 116:21; 126:23; 158:3;
measures 50:16
25;82:6,7,9,20, 22; 42:6; 48:22; 51:3; 55:14, modal 138:19; 147:17 174:9; 1%:1, 8; 197:17;
mechanism 8:3; 55:113
83:18;84:5, 13, 18;85:10, 16; 153:6; 165:18; 169:12; medals 93:14 203:9, 11;204:19
56:16; 88:2; 184:15
12;%:3; 99:1; 100:9; 170:13,20 mostly 201:2
mechanis-how moderata 41:25; 44:3;
105:21; 107:12; 115:12; micromolar 17:11, 13;
151:11 46:4, 24; 47:24; 55:1S) motif 16:10,14
124:22,23; 126:5; 128:14; 172:9
129:22,23; 132:9,10 mechanisms 16:5 modtied 13Q” ~; 161C):14; motivated 194:15
micron 1303; 131:13; 180:22
141:4;142:4,13,14’ medial 124:22 132:1 motivatas 193:23
147:16;148:3;154:4,5; modify 15:21,21; 133:19; mountains 166:191
median 30:3, 18;31:1,4; microns 25:13;33:12;
155:19;160:18;162:19; 179:16 mounting 101:18
35:11, 17,22; 36:2,6,12, 82:7, 8; 103:3,4; 128:23,
169:9;174:23;175:3; 18,24, 25; 37:5; 38:6,9 molar 17:15 move 6:12; 12:8; 13:21;
23, 24; 130:8,10
. -181:12;182:3,6,8,9, 17; 146:4; 150:19 152:13; molecular 16:16 28:11; 189:7;201:14
184:2,24, 25; 186:14; microphone 28:11;
153:15,16,17, 20; 154:2; 154:8; 174:1 md?CUiS 17:3,6 moved 37:4; 166:19
4M:7; 194:13)14,16,18,
_- 160:12,14, 15; 161:15
“’98:23;199:12;200:4; microphones 4:8 mOleCUieS15:18; 16:2 fllOViC!S9:20
19;203:8; 206:20 median-who 146:4 mid 166:3 moment 1917; 29:22; Moving 85:17; 132:4,4;
IW3dhIIIS 35:21; 50:1; 32:4; 33:10; 34:22; 35:12; 180:11;189:11,13
/be 4:9; 59:19;69:1, mid-’8Os 149:4
2, 15;70:12;82:9; 102:23; 152:7,15 43:19, 25; 54:20; 56:1 Mr 6:3; 9:2; 11:24;75:18,
mid-400s 145:13
112:25;115:2;122:5; mediators 16:1 momentarily 83:19 21;76:8, 11, 21,24 ;95:10,
mid-third 140:20
133:4;138:21;139:3; Medicaid 199:19;200:7, monetary 9:4 11;%:21; 97:16; 98:9;
143:1o;144:10;146:19; 16 middle 1%:17; 208:13
Monette 9:20 99:4,5, 17; 112:19;113:5,
156:11;161:19;169:9; Medical 4:13, 15; 5:6; might 29:18;49:16; 57:9; 6,11, 14; 114:18,24;
6(k5; 68:12; 84:21; 85:8; monlas 65:7
171:4;173:20;174:2; 70:21; 185:25; 186:2; 116:5; 118:6;120:7, 12;
192:18;198:25;200:5; 86:10; 91:7; 94:14; 95:21; monttor 61:7; 201:7 125:5; 126:13, 14;127:18;
205:6
207:9 98:12, 18; 104:1;107:18; Monitoring 6:5; 22:25; 128:9; 136:8, 13; 137:14,
Medcara 200:7,16 133:8;141:25;142:25;
McGOODWIN 4:21, 21; 165:13; 167:2; 168:9 15; 148:17; 150:23;
medication 68:21; 141:9; 144:11;147:2;148:7; 169:17;201:11
5:8, 10;207:9,10,14 154:10;155:4; 167:5,6;
173:3; 182:5,5 156:25;159:24;162:4,17,
me 9:25; 10:4; 14:18; month 21:7; 166:10; 179:3,4; 185:15, 18;
medications 61:2, 4; 18; 165:7;169:22;173:21, 167:25;170:17;171:1; 189:5,15, 17; 193:24;
23:12; 25:1; 42:3; 50:12; 67:24; 92:8; 99:8; 141:3 22; 179:7;183:10;1%23;
56:3;64:8,24 ;66:1,7; 210:18 198:13, 14;205:22;
medications-l 67:21 187:10, 11; 189:25;190:5; monthly 78:17; 133:22; 206:23; 207:7,7,13, 15;
68:22; 71:22; 75:7; 77:17; 191:9;197:8;204:18
79:20; 83:5; 87:16; 909; medkine 184:12 161:2;165:19 209:8,14
101:3,4;103:14,23; meet 29:12 might-in 147:25 months 9:11; 13:1;34:8; Mrs 177:2; 184:10
105:15; 106:14; 108:19; meeting 4:3; 5:12,14, 19; mike s7: 19 50:9; 55:4, 4; 98:4; 139:17; MS4:11,21; 5:1O;6:15;
113:20,25; 121:11; 122:5; 7:2; 12:11;44:12; 71:8; mild 41:25; 44:3; 46:4, 24; 140:12; 141:24; 150:20; 61:23, 24;62:25;63:8;
123:21; 126:19; 128:5, 18; 10622, 24; 136:3; 195:23 47:24;55:19 - 152:11;153:17,21; 64:8, 24;65:23; 66:7,10,
129:14;137:11,23; meets 178:25 mild-moderstesarious 154:19; 163:3,9,16, “19, 20;67:11,18; 68:17,23;
139:10; 141:11; 146:18; 59:1 21; 168:16 69:1, 22; 101:11, 13;
member 4:12; 22:17, 25;
148:2; 149:14; 158:16; miles 64:23; 65:4 more 13:8; 17:14; 18:13; 103:11, 12; 104:8, 11;
56:4;64:16; 168:15; 187:9
159:21; 162:13; 169:5; 1910; 21:22;25:3,4,5,5, 121:22,23; 122:23;
members 4:7; 14:1,2; mind 45:8; 59:20;61:1;
176:7; 178:9; 181:4,5, 15; 6;26:11;33:11,13,1’5,23; 123:20;124:1,12, 25;
112:16; 204:5, 21,25; 73:4; 83:16; 91:12; %:21;
185:9; 188:12; 199:3; 34:16; 35:22;37:23; 38:9; 125:12; 172:19,21; 173:1,
207:8 97:14; 127:12; 137:18 2; 174:7;177:21, 22;
210:5 42:1, 24;45:7,7, 21,21;
membranes 45:20; 14017; 144:25; 146:12;
_~an 13:7;49:23; 71:10; 46:11;47:14, 24;49:11, 1786,14,17, 25; 188:3,4;
52:18 148:6,6; 160:11,24;
“9;87:2;88:12;90:4,8; 25;507, 8; 54:5;58:11, 190:11, 12; 191:7; 198:5,
179:9; 180:7;185:21;
3; 102:8; 113:16; memory 127:21 18;60:13; 63:15; 65:112; 7; 207:9,10, 14;210:7
187:9; 189:21;201:6
1;124:1,4,7; 125:8; mentioned 24:15; 34:24; 66:8;69:25;77:7;80:16, much 9:25; 11:19; 13:20;
mind-was 142:14
1A:1O; 131:11; 150:9, 18; 52:12, 20; 58:6; 80:3, 25; 20;82:21, 23;84:7;9:2:13; 15:22; 1910, 10;36:5;
152:13;155:10; 161:15; 87:17; 88:22; 98:7; 109:6; minds 122:2,3,3 97:9;98:12; 104:16; 63:5;69:22; 70:18;75:7;
177:25;178:1,2,5, 14; 111:10; 118:8; 120:13; mine 76:25; 107:13; 105:16; 112:17;116:’13; 77:7;86:20; 87:5;88i9, 14; “
183:1,22; 184:14;186:25, 153:2; 162:7;181:23; 116:20; 121:20; 126:10 117:10:123:3:126:5: 91:13; 92:13;98:25;
25:187:1:190:23:192:13: 185:6; 198:9 minitn$l 188:23 13010~ 133:20; 136:i3; 100:9;102:12,17, 20;

matter - much (20~
opthaldc Drugs Subcommittee of the
Dermatologic and Opthalmic Drug Advisory Crete July 22,1998
103;6 10,22, 25; 106:6; 88:9,14, 19;98:1; 100:18; nine 61:1; 163:21; 168:16 19, 21; 104:3, 2!4;105:3; 208:12
10711; 110:21,21; 118:3; 161:5; 194:19; 201:10 no 5:18; 12:Z 17:18; 106:4; 108:8,2,1;109:2, now-what 201:17
‘-- lz4:Iq 142:4, 21; 144:10 203:8 20:20; 26:13; 29:3; 31:4; 15, 18;110:1, 1[,4,21,25;
nuclaase 17:6
147:2; 149:19,22; 164:4; nacassarify-it 125:11 37:21,23; 39:21;41:14, 112:6,9; 113:13; 114:14,
165:4, 19;188:19,24, 25; 20; 115:5,6,7,8,18,23, nuclaotides 16:21
necessary 182:21; 15, 20;47:18; 51:17;
194:14, 16;1%:1, 4; 193:21; 200:24; 201:11; 54:11;55:18; 56:12; 24; 1161, 16; 1.18:9,11, number 7:7; 8:7, 19;
19823; 199:4,4; 201:3,8, 57:25; 58:9,14, 21; 60:1; 18; 119:25; 120:5,~ 12:14,15,19,23, 25;
206:14
13 65:11; 66:4; 73:4; 75:10; 121:12;122:3,6; 124:1,9, 58:13,14,21, 23; 59:9;
need 5:22; 8:19; 15:6,9; 62:7; 71:6, 18;72: 15;
multi 149:15 76:4, 17;77:3; 83:6; 88:1; 23; 125:8,10,1.0, 25;
20:14; 71:11;88:23; 89:7, 73:13,1 T74:I0,11,15,
Multidrug 18:14 90:18, 24; 94:5; 95:8; 126:4, 11; 127:4,11,12,
8; 177:23; 197:8;200:10; 23; 75:25; 76:1, 16;78:8,
multi-predictor 138:19 105:14; 107:7,9; 108:20 15; 128:4,5,19, 20;
203:8; 205:12,13,14,15, 129:13,19, 21; 130:24; 21;79:11;87:15, 17, 20;
113:3,13; 124:1, 12;
multiple 19:1S;46:16; 16210:6 132:4, 19; 134:8; 136:19, 88:7; 89:11; 90:2, 15;
127:4,7; 128:7; 129:5,7,
58:3; 100:15; 155:16; needed 12:18; 1%:15 22; 133:2; 134:12, 15; 20; 137:25;138:4,6; 91:11, 13;94:2; 97798:2,
161:16 needed-caused 44:16 136:6; 137:10; 138:6; 139:19; 14022,24, 25; 11, 19;92, 15, 16;
murky 122:5 139:17; 141:22; 142:20; 142:13, 14; 144:15,21; 101:18,25;103:17;
needle 66:3, 5; 136:20, 104:20;105:5; 108:23,24;
must 122:5; 157:23 21,21 143:8,8; 145:10; 148:25; 146:4; 147:16148:2, 3;
152:1; 153:14; 159:25; 155:1;158:9,11,13,22, 126:3;137:21; 151:18, 19;
fdy6:15; 9:2,3,13,15; needs 20:12, 24; 26:13;
166:11;168:8;169:25; 24; 160:19,22; 161:3,4, 161:15; 162:6, 16;163:9;
10:1,9,14,15,16,23, 25; 61:12; 89:1, 15; 195:5;
1703,5,13, 15;171:1; 18; 164:9, 13; ][65:12; 164:12;171:4; 178:20;
11:1,3; 12:22; 13:12, 15,
201:21 167:4;168:19;170:5; 197:12,19, 25; 200:16;
24; 14:24; 23:12,13, 13; 172:9, 10; 175:6 17622;
NEI 22:18 183:5;195:17; 1%:13; 171:9;172:1,7, 13; 173:5; 203:6;209:6,16,22,25
56:7; 57:2, 14;64:6, 21;
65:23; 70:19; 74:15, 20; neither 7:1; 62:19;90:5 198:1,4; 2(X120;201:8, 174:2;176:21;177:13; number-a 161:15
75:4, 15;77:2; 78:22; neither-one 81:25 22; 202:7,10, 13;203:11, 178:7 17923; 1806,8, numbers 7:22; 13:2;
83:15;87:12; 89:11; nephrotoxicity 186:19 18;204:20, 24; 206:10; 20,21; 181:3, 18;182:3, 24:22,25; 595; 6&1(3
91:11, I&~O;94:20; 207:4 16;1s3.2, 4, 12; 184:2,6, 704; 71:2073:14, 20;
nerva 25:18; 52:11 B,24,25; 185:3,8,11,13, 78:5;7%16, 23, 25;80:18,
%.li i9; 97:14; 101:4,5; no-1 76:16
102:16; 105:19; 106:2; nevar 6:25; 7:6 36:23; 19;186:10,25, 25; 187:2, 19;90:11;92$; 93:13, 20;
no-we 142:19
116:2; 117:16; 118:22; 71:20, 21; 92:24; 99:12; 7;188:21; 1X:19; 191:8, %:5; xO&15, 22 151:5,9;
116:11; 131:4,6; 140:4; non-approval 207:4,21 14,19,20,21, 24; 192:2, 152:5,6, 12, 13; 160:18,
,. 121:13; 123:20; 126:22;
127:11; 129:25; 134:19; 164:15; 182:22; 187:12 non+!xistent 82:25 i, 16, 20; 193:6,17,23, 20; 163:25; 164:2,3;
136:9, 13, 16; 140:8; new8:ll, 12, 13, 17, 19; non-functional 131:1 25;194:19,25; 198:4,20; 176:16; 182:14; 202:18 “
s-. 146:12; 148:6; 153:14; 9:16; 12:1;14:21; 16:12, non-M.D 177:5 199:12;200:4,10,14,15, numerical 79:14
162:5; 165:24; 166:15; 14, 16;19:6;23:11;25:13; non-sampling 100:9 22;201:3, 10;202:20; numerous 121:21
168:18; 169:18; 173:19; 105:9;123:11; 148:22; 203:7;204:13;205:8;
non-voting 207:8 207:13;208:8,11,17, 18;
174:2; 176:5; 177:9, 17; 163:7;164:3; 165:4;
179:9, 14; 180:7; 181:16 172:22; 177:11; 188:5; none 45:14;46:8; 58:2;
138:5
209:1,1,9; 210:15,23 0
184:19; 185:21; 186:3; 193:4;208:20 not~o 169:1
188:12, 14; 189:8; 190:10 nor 60: 15;90:6; 178:8
nawty 14:6;18:6;21:17; not-1 124:1 o’clock 70:14; 135:8
191:14,15, 21; 192:8; 27:21, 25; 28:4;32:22; normel-appeering not-in 1271 rn Dbjedh 171:2
200:17;201:6;204:7; 36:4;38:14;48:21; 54:17; 130:8
not-the 71:14 objectively 6:2
206:8;208:8;209:6, 7; 55:14, 25;56:11; 145:14; North 69:7,11
210:10 not-thare 75:6 objectives 73:15
159:19; 16m13; 161:24; not 5:209:4; 10:10,15,
my-if 121:16 163:4;165:7 25; 12:8;13:1,5,7,7,10, nOHO 178:9 obliterated 87:1
myself lo:ll; ll:15; news 17:23;18:1;19:3 11,14, 15;21:25;28:6; note 6:24; 30:6; 181:23; obsewation 81:24;
14:14;75:25; 82:20; 2912; 30:5, 14;31:6,13, 182:10 152:24
next 8:25; 10:14,20, 21;
94:24; 101:21;111:10 15:14; 16:19;17:9,20; 18;35:13;37:5, 12;40:5, f’IO@d5:24;7:18; 3021; observation-and
19:11;20:1,11,22;21:11, 13;43:6;44:7;45:18, 24; 41:2;46:13 152:18
46:10, 20; 50:21;52:4; nothing 141::20;186:6
N 24; 22:6, 13;24:2,9, 19;
25:8;26:7, 21; 294; 301; 53:2,10, 15;56:25;58:14; 201:25; 202:5,,7
observational 62:15
observations 121:25;
31:8, 22; 32:10; 33:6; 5925; 60:11;61:21; 62:3, notice 31:25; 46:22; 152:19,20
n 51:16; 53:6 34:17, 23;35:7, 15;36:1, 5,5, 9;63:13; 65:19; 67:8, 47:13;84:24; 85:2, 3,4;
16, 16;68:11, 25;69:18; observations-these
neivete 123:20 8;37:1; 3%640:1,10; 86:11 152:19
43:23; 44:4, 25;46:5,21, 71:7,10,15, 15;72:3,9,
name 6:15;9:2; 13:24; noticed 66:1‘1,12, 13; observed 25:22, 25;
90:16; 136:13;174:2 25;495; 50:4;51:2,10, 14,18, 24;73:23;74:10,
198:7 26:2, 19; 28:10, 13; 30:24;
11;52:15;54:3;70:23; 17, 22;75:1, 6; 76:4;
National 4:17, 18;6:21; 77:10,13, 20;78:2, 6; notions 166:13 31:14, 20; 33:18; 36:11;
22:17,20, 22; 199:17 71:4, 17,24 ;72:6, 21;
73:8, 19;74:13; 75:17; 792,15, 24;8&14, 18; notorious 184:11; 51:21; 52:5, 6; 53:8, 10;
Native 69:12 81:1, 17,22; 82:1,11, 15; 185:23 88:8; 90:17; 151:6
~.5, 15,23;78:12,18, 25;
natural 50:22;97:4; 79:9, 19;80:1,5,12,15, 83:1,2,3,7,8,10,11,15, now 5:8; 10:13; 36:17; obstacle 194:4, 18
120:1 22;82:18;84:6; 85:24, 24; 15,21 ;84:1,9, 10,19,21, 57:8; 63:8; 64:20; 65:17; obstacles 199:1I
nature 103:15; 182:1,6 87:10,24 ;88:11,24; 23;85:12; 86:12,17; 87:1, 66:9; 68:12; 70:1, 16; obtain 39:17
.-.. NDA 13:6;23:3;72:12; 89:10, 23; 108:12;110:8; 18;88:4,6,8,13,15, 18; 85:21; 86:6, 8; %2,8;
obtainad 39:12, i3;
73:11;78:21;80:9; 91:19, 111:3, 17; 118:14; 129:22; 89:3,4,8,12,14, 20; 106:10; 12019,24; 134:8;
40:25
19 157:4,20 90:19,22,23, 24;91:1,3, 136:5; 137:9; 138:22;
5,7;92:4,6,11,12,21; 139:14; 140:16; 146:11; obvious 142:24; 174:12;
neer 72:18 nice 105:4,6; 192:14; 177:17
193:5,7; 1%:23 93:15; 94:4,5,6, Z 95:4, 149:23; 152:12;158:25;
nearly 57:24; 166:4 7, 24;%:14, 20;97:14, 24; 162:4; 163:8; 165:21; obviously 58:18;77:3;
necessarily 62: 10; night 10:19 167:3,22; 16$z3;170:14; 98:12; 129:14; 183:18;
98:3,4,6,16,24, 25;
71:10;74:10;79:15; 81:1; night-we 66:12 99:13,21; 10&l, 17,20, 171:22;172:22; 192:12; 193:8
82:22;83:7;84:19;87:2; NIH-sponsorad 130:18 23; 101:9; 102:8; 103:10, 193:2;201:18; 20723; occlusion 52:18

Miller Reporting Company, Inc. Min-u-scritwo
Opthalmic Druge Subcommittee of the
July 22,1998 Dermatologic and Opt.hahmicDrug Advisory Crete

occur 43:4;65:16; 88:7; 23,25; 59:17,18,18,21, 132:9,12, 25; 133:2,23; 210:13,16,17 98:13; 100:16; 101:6;
LEJ 21,23, 24;6@2,4, 5,7,8, 134:3,5,6,9,19, 22; >f-end 69:16 102:24; 103:6; 105:18;
rred 12:16;
83:10; B,10,14, 20,21 ;61:3, 12, 135:4,7; 136:14,14,16, >f-for 97:24 106:20; 107:22; 108:7, 21;
12,18,19, 24; 62:4,5,6, 17, 24; 137:4,6,8,17,21, 109:8,11,13,14,25, 25;
>f-in 72:15
15, 17;63:9,11,22, 25; 23; 138:5,6,7,13, 14; 110:3,13;112:14; 113:1,
o~curring 83:17 >f-these 152:12
64:4,5,11,21,22, 24; 139:10,12,16,18,19 7,25; 114:11, 15;115:2,8,
occurs 20:4; 81:2; 65:6,6,6,7,7,9,11,11, 140:1,3,6,8,10,11,17, >f-whenever 139:23 18;117:23; 118:1,8;
120:17 19,20141:6,19,19,22, >ff 4:6,9 19:5; 26:5; 119:11;121:24; 122:24;
12,14,16, 21,24,25;
ocular 21:3; 23:14; 26:5; 66:5,13,18,18,19,19, 23, 24; 142:10,12,12,18, )5:17; 47:10; 68:13; 125:16;126:3, 16;127:14,
41:1,2,6,10,22,24; 22,23,23, 25;67:3,4,5,9, 18,22, 25; 143:11,12,14, 7610; 91:2~ 101:3; 19;128:21; 129:6, 13;
42:22; 43:3, 24; 44:2; 47:8, 10;68:1,3,4,8, 12;69:4, 16,21,25; 144:13;145:11, 115:9;126:6;13021; 131:25;133:4; 134:3;
16,20,22,22, 25; 48:1; 13,14,16,17, 1A 70:2,5, 13,15, 22; 1464,5,9,12, 139:17;141:19; 142:11; 136:14,18; 137:17,23;
49:19; 53:9,11 ;55:18; 7,19,19, 20;71:1,6,18, 16,17,21,22, 25; 147:2, 1481; 151:7; 189:15; 138:2,5; 139:10, 15;
58:7;63:22; 151:17 20, 22;72:12,13,15,17, 8,9,10,1°,20, 24; 148:4, 197:9;201:24; 208:16 140:4;141:2,14,14,18,
of 4:3,4,6,8, 14, 18,22, 23;73:1,6,7, 11,13,16, 5,10,16,20,22,23, 23; >ff-label 172:21,23; 19,20,21; 142:8,11, 21;
25; 5:2,4,9,11,12,13,13, 16,17,20,21,21, 23; 149:3,6,9,11,13,14, 16; 173:3,6, 13; 184:11; 143:11;144:12; 145:1;
19, 22;6:5,8,18,18, 24; 74:2,15,16,17,18, 23; 150:1,2,5,10,14,17,18, 185:23,24; 186:7, 11; 146:17;14716,21; 148:1,
7:6,7,10,11,12,16,18, 75:15,16, 25;76:1,15,22, 24, 25; 151:2,8,14,19, 188:8 22;149:12,13,14, 20;
22,22, 25;8:1,3,7,14,17, 25;77:6,21,21; 78:5,6,8, 19,23, 24; 152:2,3,4,16, 3ff-study 153:3 150:1,16, 19,20; 151:19;
19,21, 22;97, 13,15,22, 8, 10,21,21 ;79:5, 11, 16; 17,18,18,20, 23; 153:18, 152:13,24; 153:1, 10;
Sffer 8:12; 2017 154:16, 17; 156:20;158:2,
25; 10:1,3,5,23, 24; 11:6, 80:6,7,9,10, 19;81:5,5, 20, 21,23; 154:17,20,21, tffered 2823
23, 23; 155:2,10,14, 19; 14;159:21; 160:6; 161:21,
10,12,16, 24; 12:9,14, 7,8,14,18,20, 24;82:13; Dffice 5:4; 137:10 23;162:2, 12; 163:2, 11;
14,15,16,19, 19,23; 83:2,9,16,16,19,20, 21; 1566,7,8,13,14,14, 17;
Officer 5:6; 14:10 165:14;167:1,2,10, 16;
13:1;14:1,2,5,6,8,9,23, 84:4,10,12,12,16, 17; 157:2,9, 10; 158:25; 168:9,11,17, 25; 171:22;
23, 24; 15:1,2,13,23, 25; 85:3,7,15, 25;86:2,2,7, 159:12, 18;160:2,4,9,16, offker’s 70:22
Ofte- fl .;63:24; l16:7;
174:11,22; 175:2,24, 24;
16:2,5,5,6,11,13,17, 20, 12,19,20,22,23,23, 25; 24; 161:3,6, 15; 162:1,6, 179:14, 16;180:2,3,9,12,
23, 24,25; 17:1,1,5,11, 87:9,9,15,16, 21;88:3,3, 14,16,16,19,21, 24; 12014,19
15; 182:7, 15; 183:14!
17, 22; 18:3,4,6, 14; 19:3, 7,17,19, 20;892, 11; 163:1,3,7,9,13,15,17, Oh 157:2; 158:20; 175:13; 184:4,7; 185:7, 16;187:5,
4,6,7,9,13,19,21,22, W2, 3,10,15, 15;91:2,6, 19,21, 21; 164:12,12, 20; 206:23 14,15, 25; 188:6, 17;
‘23; 20:3,5,8,9,14,15,18, 13,16,2092:2,2,7,7,9, 165:3,4,14, 23; 166:3,10, t)key 58:17;66:1; 67:18; 189:7;190:10; 191:11;
19,25;21:8,21, 22; 22:4, 10,12,12,13,18,22,23, 13,25; 167:1,2,6,11,13, 58:23;691; 76:24; 104:8, 193:17;194:1,12, 19;
= 11,14,16,16,17,17, 24;93:2,4,14,2094:2,8, 19; 168:8,12, 15; 1697,9, 11;112:24;113:4; 136:7, 1%:3, 13;200:2, 15;
‘1, 24, 25;23:1,4, 19, 11,14,15,18, 19,22; 11,12, 15,18,25; 1701, 19;137:15, 16; 138:2,5; 201:14;202:12; 204:3, 13;
$, 25; 24:4,8,13,17, 95:1,4,12,14,17,20,22, 5,10,11,12,13,15,16, 158:12;161:21; 176:11; 205:25;207:4, 24; 209:9,
5;25:3,9,9, 10, 13, 24,25, 25;%:1, 2,4,4,9, 16,19,21,21,23, 25; 178:10;189:13; 191:12; 22,22,24
13,14,14,17, 22;26:2, 5, 10,11,12,18,21, 22,24; 171:1,2,3,4,10,11,15, 201:14,22; 202:2, 11; on-treetmerrt 152:4
16;27:10,16,18, 20; 97:1,3,7,8,13,24, 24; 23; 172:5,6,12,22, 25; 203:14,21; 206:25;
28:14,19,19, 22; 29:5,11, 98:1,3,4,7,7,11,13,13, 173:3,10, 20; 174:3,4,6, once 9:11; 21:7;28:18;
?07:23
15;30:3,7,8, 11,20,21; 15,18,19,20,20, 22; 11,14,15,16,17,18,19, }3:3;35:3;40:19,21, 22;
digonucleotide 14::21; ;1:18;60:23; 111:20
31:2,3,4,5,9,16, 23; 39:2,15,16,18, 20; 100:5, 23,25; 175:3,5,5,10,12, ,5:16; 1620, 21; 17:4;
32:3,5,13,15,16,21,22, 9,10,21, 22; 101:9,15, 15, 17; 176:1,5,5,6,17, me 97, 25; 1024; 11:10,
S:24
23, 25;33:3,9,10,20 17,20, 25; 102:6,25; 21,22; 177:5,11,17, 19; 11,12;13:15; 15:23;
~ligonucleotides 16:14; 1610; 17:15; 19:12,22;
34:3, 13;35:2,2,5,22, 24; 103:1,7,13,13,16,17, 178:2,5,11,12,20, 22;
[7:8 26:10,25; 27:1,3; 29:11;
36:9,17, 22;37:7,9,9,10, 20,21, 21; 104:4,9,20, 179:5,8, ?1,22,23,25,
14,16,18, 25; 38:9,10, 21; 105:4,5,5,5,8,10,21, 25, 25; 180:15,18,19,22, >mit 48:16 50:6;31:2;38:22, 24;
14,15,17,21,21, 23,25; 23; 106:7,8,19,23, 23; 25; 181:9,13,15,21, 24; m 5:15,21 ;6:4, 12, 17; io:16, 20;42:14; 43:12;
39:1,3,4,9,10,11,12, 12, 107:2,7,10,14,22, 24; 182:1, 1,4,6,8; 183:9, 11; 7:14,25;8:12; 10:13, 18; i4:19, 22;45:24;49:12;
15,21,22, 23;403, 10, 108:1,4,4,5,7,9,15,16, 184:5,9,12,15,16,23, 11:10;12:8,23; 13:21; 52:22;53:7,9; 54:18; 55:3,
16,20,22 ;41:1,2,5,6,8, 25; 109:2,10,19,19,22, 24; 185:3,24; 18&19,22, 14:13;15:1,3,4,7, 22; ~;58:11; 59:15;60:13;
14,17,18,19,22,22, 24; 25;1103,7,19111 :1,7, 22; 187:4,4,12,15, 25; 17:4,14, 25; 18:23;2CL13; 51:5;64:21;65:6,21;
42:5, 14,17,18,18,19, 7,11,14,15,24, 25; 188:5,8,17,19,20,20, 21:13;22:1;23:25; 24:3; %.24, 25;67:18; 68:17;
23;43:3,5,9,11,24, 24; 112:3,5,9,14, 14; 113:7, 22,23, 25; 1891,12,20, 25:11,22; 26:1,3,14, 19; 59:25;73:1;74:20; 75:1,
44:1,5,6,9,10, 13,21; 21,22, 25; 114:20,25; 20,23, 23; 15MY4,6,16, 27:9,2Q 28:2,13, 15; 22;77:6; 78:10;79:20;
45:1,5,6,10, 20;46:1,3, 115:2,6,13,16,16,21, 21; 191:1,4,4,5,10,16, 29:6,13, 23; 30:8;31:9; WJ13;81:20,21;82:4, 5;
7,7,8,13,17,19,22,23, 22, 22; 116:9,10,12,18, 17,17,19,22,23, 25; 32:8;33:11,18, 24;3qi:25; 84:22;85:2;87:6;88:20;
23;47:8,8, 11,13,15, 15, 20, 22; 117:4,6,6,7,8,13, 192:1,1,2,4,10,10,11, 3&2~ 40:23; 41:1,9; 42:5, 95:12;%:3, 18;99:5, 8;
21,21,23,25, 25;48:8,9, 16,17,19,19, 21; 118:2, 12, 19; 193:3,11,12, 20; B;44:1048:23, 25;49:15, 100:23;102:1, 23; 103:2,
16, 16,21;49:1, 14,16, 2,4,4,4,9,14,15,21,23, 194:6,24, 25; 195:5,8,8, 23;50:5,11; 51:12;53:12, 3,4; 105:5, 15;106:19;
17,20,21,23 ;50:1,1,5,6, 24, 24; 119:7,7,12,14, 9,11, 17,19; 1%:1,1,7,9, 23;54:4;56:25;57:2; 107:14,25; 108:21;
9,13,22, 23;51:1,8,9, 12, 14,22 ;120:1,4,4,4,8,9, 11,14,22, 22; 197:1,10, 5810, 12;6CL2,6,11,14, 109:10,24; 110:5,25;
15,21,23,23, 24; 52:1,2, 18,23,23, 25; 121:1,4,8, 10,12,14,19,20, 22; 17,20,22, 25;63:2;64:1, 112:9; 117:4; 119:12;
3,8,13,18,21,22, 23; 12,14,14,17, 24; 122:1, 198:2,11, 22,25; 199:2, 5;66:22; 68:1672: lCI,14; 120:7; 126:15,20, 20;
~~5,6, 11,12,13,14,15, 2,4,6,7,10,11,12,12, 11, 19,22,24 ;2~l, 16, 73:22;74:12,15,16, 21; 129:16; 131:24;133:3;
7,20,20,24, 25; 15,17,18, 19;123:4,13, 17;201:6,18, 23; 202:18, 75:8;76:5;79:12, 22; 134:1, 12; 136:13, 14;
6,7,9,9,11,12,13, 18,24, 25; 124:2,3,5,15, 25; 203:4,4,15,22,24, 80:18,1 ~82:3;83:l,3,6, 137:6 138:10; 14021;
8,21,22,22 ;55:1,3, 21, 24; 125:8,17, 21; 25; 204:3,5,9,12,18,21, 8,9; 84:6, 11;85:17; 86:4; 141:18; 143:2;144:13;
3,8,8,9,10,10,13,14, 126:3,16,20,20,20, 23; 22, 24;205:3,24, 25; 87:1,4, 10;88:8,8, 21; 145:7, 13; 150:3,7, 11;
16;56:3,4,7,10,11,12, 127:1,2, 16;128:6,13,14, 206:6, 21; 207:7,8,11,18, 8911,21 ;$M19,24;91:21; 151:21,24;152:8,9;
15,16,17,18,19,24,24, 17,21; 129:1,3,8,15,18, 20,22,23,24, 25; 208:1, 92:2, 10;93:11,16, 2’5; 153:1, 12;155:20; 157:14,
25; 57:1,1,4,23, 25; 58:2, 20,25; 130:1,7,8,11,12, 7,10,12,13,16,20,21, 94:7,7,20,22, 23;95:6, 20; 159:24; 161:21;
3,4,5,9,10,14,15,21, 21,23, 23; 131:4,5, 5,8,9; 24, 24; 209:12,19, 25; I 18,24; %:25; 97:10, 19; 162:17; 166:2, 10;167:9;

nrrllr - nlle (22)
Opthalmic Drugs Subcommittee of the
Dermatologic and Opthalmic Drug Advisory Crete Jdy 22,1998

170:2-7;171:1;174:4; >ptimel 180:2 $9:1 143:17,21; 153:22; 149:20;184:4; 185:7;
180:19;181:23; 182:9; >ption 8:6; 10:10; 194:9 xphan 18:8; 165:25; 154:21;161:13; 164:13; 201:15;202:24
184:21;187:3,6; 189:16, tptions 8:20; 10:4,9; [67:9 i69:21; 180:12,,21; paneliets 137:17; 139:7;
21; 195:22;1%:18; i6:21; 158:8; 203:13, 18 >ther 5:2cl 6:7; 7:12; 185:22;186:18,,19; 189:6; 173:1Z 175:22,23
198:15;199:8,22; 203:18, [1:10,11 ;13:15; 19:20; 190:5;192:23; l~94:13; panoply 142:10
lr 5:20; 6:8,25; 7:1,9,9,
20; 205:14,22; 207:13; ZO:19;21:25; 26:14, !7, 200:13;201:6; 208:7
11,12;13:11, 15;16:1; paper-you 185:10
208:5, 18;209:12; 210:4, [9; 29:13; 30:13; 33:5; wtcome 125::~1; 137:23;
~7:14;18:11; 19:14; papers 26:17
13 }4:9, 10;36:15; 37:3, 25; 138:15;145:21; 170:18;
?0:14;23:11; 24:21; paracentesis 43:15
ones 47:24; 55:20;67:11; !8: 16; 29:2, 19;32:24; 11:19;43:2; 44:17; 45:1,5, 187:22
145:3;164:13; 177:14; ), 20; 46:6; 47:4; 49:3,8, >Utliers 31:25; 145:19 paradoxkal 159:21
}3:21; 36:21, 23; 37:2,10,
201:3 [4; 38:1, 16; 39:10,22, 24; \ 53:4; 59:2, 15;62:3; mtlined 64:7 parameters 134:16;
ongoing 31:3; 165:6, 11; [0:13; 41:8, 16;42:12; 53:25;65:17; 67:18, ?1, 191:1
>utside 117:17; 131:8
193:10;195:10 i3:12, 13;44:13, 14;45:5; 23;68:4, 8; 691o; 70:20; paramount 61:12;
71:11;72:23; 73:1; 74:20; ~ver6:22; 11:2; 12:14,
only 15:4;30:13;40:19, 16:19;48:13; 50:14,17, 188:24
75:15;81:22, 24; 82:1, 5; 15;18:10; 23:7; 28:24;
21;43:21;44:19; 51:18 ?3;51:1,7,9, 18;56:20; Paris 11:6
33:23;85:21;92:7, 24; }1:1; 32:6,8, 17; 38:7;
58:24;68:2;71:15;72:2; j7:l~ 5811; 59:19; 60:8; 3%2,15;40:20, 20; 48:2; part 5:13;43:20;65:ll;
?4:13;97:8; 98: 10;99:15,
73:6;74:23;75:12;77:14; 51:1,5,7, 15,20;62:1, 12, 55:1;59:6, 13;60:10; S8:8;71:22; 92:7, 23;
16;1~23, 25; 101:8,22,
80:9;89:14;90:17, 20; 1$+63:11,25; 66:9; 67:4; 51:13;67:1%75:25; 76:3; 119:12;138:6; 140:19;
22;102:24; 103:22;
93:15; 104:3;106:20; 58:13;71:22; 72:10; 142:17;151:15; 161:7;
106:16;107:7; 113:2; 31:5,19;86:4; 101:6;
119:18;125:8;133:4; 74:18,20, 22;75:1, 2; 172:25;179:23; 187:15;
116:11;121:11; 123:7; 109:8,14; 112:20119:20
134:4;139:19;142:12; 7810, 16;81:2,17, 21; 207:24;208:12
125:17,19; 126:1; 127:3, 120:4;121:21, 21; 126:23;
149:21;150:7;157:17; 32:16,23, 25; 83:%84:13,
$,10; 131:18; 133:3; 141:6,24; 143:15; 145:3, partially 86:25
168:19;180:23;186:3; 15,18;85:24; 87:16;897;
137:19;1397,8, 20; 5,16; 146:23; 1’51:22; participant 5:21
187:16;193:23;199:24; )1:4, 10;92:10; 93:13, 15; 154:17;156:14, 18, 19;
141:21;151:22; 155:21; participants 5:16, 22;
201:1F;207:13;209:11 )4:8, 21; 95:3,3, 17;98:2, 163:12 164:2; 1703;
15712; 158:4,8,9; $2, 7; 7:24; 8:9
ons i, 25; 32:23; Z;100:1,23; 102:16,23; 175:3;177:3; 195:17;
159:12,14; 161:8; 168:5;
37:18; 151:7 103:2,15; 104:16;105:16; 20915 partkipstiorrt 12:12
171:12;172:18; 173:17;
110:21;114:2,9, 14; partkular 71:21;74:15,
onto 107:6;189:13; 174:22;180:5, 18; 181:5, Overall 37:15; 41:24;
200:11 115:5,13;11614; 119:17, 22;75:4; 83:1,7, 12;
.---- 25;182:4,8, 19; 184:3,22; i5:14; 46:1047:6, 17;
20;121:1,8, 14; 122:2,3, 34:21;85:20, 24; 89:19;
opacification 21:1;26:2; 187:1,3,5, 14; 188:17, 18; i8:l;49:10; 51:21;52:l,
[1; 129:16,19 131:19; ?0:16, 18;91:8; 94:23;
30:12,19, 22;32:23; 190:17;191:6,22, 25; 23;61:12;98:11[, 14, 2~
132:4;133:16, 16;134:13; 35:1,5,6; 97:10; 100:21,
36:11, 13;37:19; 171:19 192:3,18; 1%:4, 11; 120:8;139:10; 150:4;
136:21;137:19;140:13; 22; 102:24; 104:22,24;
opacities 43:21; 52:12 20(Y17;201:18,22, 23; 1%:16; 167:19
141:21;142:1;143:2,25; 119:3; 132:13; 179:7,24;
202:16;203:19,20, 20; wercome 186:5
opacity 124:22 146:5;152:21; 153:23,24; 189:20; 1%:14; 198:2;
204:19;205:20 206:9; warestimete 155:19
open 6:12; 12:6;57:11; 154:18,22, 24; 155:6; 206:7;20%21
208:1,10,22
71:25;72:22; 73:9;90:4, 5; 1%.6, 15,18,22, 23; Overestimated 67:1 pafiicularly 79:11;
157:11;158:6; 159:22; Mher-and 102:3
136:7;165:23;206:15 Bvertap 30:5; 35:18; 61:18;82:11;93:15;
161:12;162:25;163:3,9, Mhers 14:14;51:15;
opened 169:11 B1:1O 105:23; 164:18; 187:20,
9, 16; 164:2;166:2; 104:24;209:14,21
opening 136:9 mrerststed 208:25; 22; 188:13
167:23,24; 170:5;171:2, MherS-MSy 177:7
operating 14:9 209:1 partners 173:11
2,4; 172:17;174:2; otherwise 32:1; 104:1;
Ophthalmic 4:3, 4; 5:2; 17915; 180:21;181:2; Dverwhelmin!# 179:11; party 200:10
165:8;187:7 209:12
23:~3; 27:6; 40:24; 99:16 182:4;183:4,20; 184:11; passed 116:3; 182:24
Dur 4:ln; 7:2; 13:7; 14:9; own 101:4; 126:22;
ophthalmologist 14:12; 185:2;187:10,22; 189:14, passing 11:9
22:25; 27:12; 31:8; 41:3, 140:8; 146:12; 183:15
81:4; 174:3;200:22; 22; 191:8; 194:11,11,17, 23; 42:14, 18;43:2, 21; past 96; 22:21;82:14;
210:16 25; 195:1,7; 1%:15; 44:10,21 ;45:2, 13, 16; 98:4; 116:1; 117:15;
ophthalmologists 64:3; 198:18,25;2005,11,16, 48:16; 4917; 52:11; 53:6, P 118:21;119:1; 125:18;
149:3,6 16 201:23;202:15, 18; 14,18, 24; 59:20, 22; 61:2, 1264; 135:6; 191:18;
203:4,5,11,20204:15, 10,17; 62:17; 65:11; 201:17,17
ophthalmologists’-
who 174:19 20,20,22, 24; 205:1,1; 6&12; 6&5,12; 69:17; p32:15; 1381:2, 15; past-l 182:23
207:25, 25; 20&5, 5,18, 168:16
ophthalmology 22:16; 72:14; %:18 103:7; pathologkal 95:22
25; 209:14;210:22,22 111:18;112:11; 114:5; p-vahre 32:18; 35:12;
56:5;63:19 patient 23:20, 21; 24:15;
oral 19:13;34:10,10, 19; 115:10 122:22; 123:4; 54:17; 138:9; 145:1,22,23
opinion 18:22;74:21; 35:4;37:14;53:23;68:4; 26:23; 27:2; 29:9, 11;30:6;
124:17; 13013,15, 2~ p-values 101:6
95:2; 97:20; 99:5, 19; 77:8;999 125:21; 31:2; 4(18; 44:19; 58:6;
101:5; 126:22; 127:25; 131:21; 133:3,9; 141:25; p.m 136:2 61:8, 12;62:10,16, 19;
126:17; 165:9, 10; 167:15 142:4; 144:9; 145:2, 5; pSCkSge 12:25; 13:9;
168:18; 184:19; 191:11; 65:12; 76:9, 16;79:24;
206:8 order 30:11; 72:15, 19; 151:19; 165:13; 166:1,9; 14:19; 15:2; 21:13; 22:8, 81:3,24; 85:17; 86:11;
73:4; 137:11; 186:5; 167:2; 171:5,22, 25; ll;24:14,23; 4i3:22; 90:16,18,19, 24; 91:7;
opinions 183:17 199:15 172:14, 15; 173:11; 175:5, 55:23, 24; %:15; 97:17, 94:8; 97:9; 107:24;
opportunistic 7:5, 12; ordinarily 119:8 8, 14; 181:13;205:5; 18, 19; 100:2; 1,34:4; 108:15; 109:13,14, 23;
8:8, 15; 18:6; 19:4; 139:20 207:11;210:12
organixetion 6:22; 7:3 171:8; 173:15 110:1,2; 115:15,20,23;
.. .. opportunity 8:23; 14:1, ourselves 141:15;
organs 181:25; 182:4,8 packet 7:19; 90:15 116:3, 25; 119:9; 121:7;
3; 23:16; 28:23; 33:4; 67:2; 143:24
twienta 85:2 page 137:17; 175:24 139:23; 143:21; 144:2,4,
69:24;70:13
DUt9:3, 15;15:11; 19:2; paid 7:2; 9:3 7,8; 147:16, 25; 152:24;
OppOSed 62:16;82:8; wientetion 85:4,6, 20;
23:17;32:7;45:18; 46:10; 153:9, 10; 155:9, 17;
104:23; 143:1; 164:21; 6:4, 21; 87:9 painful 136:1!)
597; 63:11;66:12;75:16; 157:15,21;158:17,21,23;
188:15 wientations 122:17 7Z1O;78:23;86:12; pairing 16:12,,15 159:2,2,6,11, 12; 167:22;
opposite 95:18; 185:16 wiginal 73:10 59:20;94:1;%:6; 101:22; panel 14:1;151:16;33:2; 182:17;i84:16; l~:8;
optic 25:18; 33:12; 52:10 wiginaliy 77:7,11, 21; 104:1,2; 105:1; 118:4; 57:9 59:3; 105:13; 127:3; 187:10, 11; 197:12

Miller Reporting Company, InC. Min-u-scridG3 (73) #-tfl@e. --+:4 =-+
Optic Drugs Subcommittee of the
Juiy 22,1998 Dermatologic and Opthaimic Drug Mvisory Crete

patierrt’$ 1h18; 60:21; pay 20:8; 187:20; 199:20, periocular 67:4 photographic 108:20; 8;87:11,24; 88:11,24;
llJ:14; 121:7;144:11 23 period 39:3; 56:17; 83:2; 123:24 89:10; 136:12; 154:8;
—.—
“ret-you i.24:21 payer 186:9 115:16,22,25; 116:21; photographs 25:11; 207:6,19
nts 10:24;12:18,19, payers 187:18; 200:10, 118:9, 14; 139:16;141:22, 26:8, 20; 33:18; 73:21; please?-previously
~.,, ,3:4,8; 18:4,15, 17; 13 24; 151:2,9; 152:2; 76:15, 22; 81:5,6; 83:8, 33:8
20:7, 18;21:9,17,18, 19; 154:17;165:23; 169:11 12, 19;9014,15, 24; 91:3,pleese?-these 24:3
peacemaker 203:23
24:5,16,17, 25;265, 15; periods 91:6; 115:13; 4,13,
17,21;94:15;
27:9,18,21, 23;28:1, 1,
penkillin 44:13
116:6;119:14;141:19; 106:25; 19;108:4;pieesure 14:18
107:10,
Pennsylvania 12:4 109:19111 plenty 10:5; 186:22
:7;112:1,4,5;
16, 18,21; 29:1,10,13, 151:5; 163:13
17;30:16, 17,25; 31”5,9; people 6:23; 7:10,
22;
peripheral 21:18;28:6;
113:8;
114:1%115:10,17,plot 29:23; 31:23; 35:8,
32:3,5,12,13,16, 21; 8:6,8,
19;
23:24;
30:14; 46:10, 18;48:6 55:5; 19,21,
23;117:15;
118:1, 16
33:13, 2Q 34:9,15, 25; 33:1
0;60:22;
61:1;
62:2,5;161:23;169:16;170:14; 2,4,
19;121:5;
123:9; piots 111:6
35:2;36:6,20, 21;37:2, 63:19,20,21,23;
64:11, 171:3,24; 172:17;1%:19, 125:17;
126:17;
1272:3; piugged 205:1
17, 25;38:8,9; 39:8,17, 14,21,
22;
65:4,10,
18; 19; 197:7
128:1
;130:18;
131:13;
143:24;
174:12 plus 51:14; 108:1
24;40:19;41:1,9,19 67:23;
75:2;
78:3;
81:5; Permenente 4:15
82:25;
83:24;
84:10; photography 76:12; pneumonia 9:13
42:6,10,18,20 43:7;
44:10,12, 15;45:22; 85:1
1;89:16; 98:3; permission 112:13,22
92:10; 94:7; 106:15; 107:4; podium 14:17; 23:7; 57:5
46:16;50:2, 17;51:4; 104:2;
131:17,
18;136:9 permits-are 111:23 108:1; 174:25;175:6,;7,16 point 13:10, 2075:1;
52:13,21; 53:14;55:21; 137:5; 150:13; person 11:16;62:2; 81:9,
139:14; photos 25:23; 118:12 76:6; 77:14; 79:6; 87:3;
56:8,11,19, 22; 58:9,21, 153:18;
158:5;
174:8; 25; 103:3,4; 139:22; physician 121:11; 91:19; 102:2; 103:23;
23,25; 59:8,11, 12,21; 178:20; 181:19; 207:10
180:12; 174:13, 16; 186:7, 14; 114:5; 119:9; 127:18,23;
60:6,11, 14;61:17;62:8, 182:2;
184:6;
188:9; personal 56:3; 148:19; 194:7;199:13,21; 200:4 129:21; 131:21; 133:15;
17, 18;63:4, 24;65:10,17, 190:18;
195:6;
197:1~ 166:15; 173:19 physkians 42:1; 173:6; 135:4; 138:7,9; 143:21;
22, 25;68:12, 15;69:4; 201:20;
203:9,10,10,
11; personally 23:4; 73:23; 184:10, 13;185:23 146:20 147:4; 152:9;
70:3;71:2;72:1, 13,15, 204:4;
205:9,14,
15; 102:3; 160:17;201:5; 153:15, 16; 161:13, 22;
pick 4&4; 1u+:42; 143:2;
22,24, 25;73:11, 18,:’”” 210:11 204:19 164:15; 166:2; 168:23;
155:23; 17L.14
74:4,5,5,7,8,10,23, 24; pSOPld518:22 perspective 15:2; 169:18,23, 25; 170:2~
75:7;76:1, 1,2;77:12, 12, picking 103:25
people-1 95:4 128:16; 149:14; 198:16 171:6; 185:22; 191:15;
14, 18,19,2078:5,8,10, picture 86:1 202:24; 203:7, 12; 207:7
19917
~, 20;80:8,8,9, 19; per 60:15 pictures 122:16,19
per$p$dhfe-1 128:9 pOht-8SSUrdng 151:21
‘81:17;83:13,17; 87:15; perceive 182:17 piggybacks 194:17
88:7,13, 15;89:12,17, 18; ph 9:20 point-et 166:2
percent 18:8;30:4,9, 10; pigment 1712; 48:5;
~-=, 91:8;92:24;93:5,14, pharmaceutical 124:11 pointed 18(Y12
35:4,5,5; 37:7;42:18,19, 88:3; 98:8; 198:8
[:19,22;95:20;97:2, 23,23, 24;43:1,1,2,10, Pharmeceutkal’s 6:5 pOhtS 39:16;48:4,9;
22;98:11, 19; pigmentery 1%:22 49:8;83:13;%:6; 177:17
11, 11;44:6,7, 13;45:14, Pharmaceuticals 7:1;
101:17,25; 104:2;4; pilot 71:25 poie 9:23
15;46:7,8,11, 11, 17,18; 13:22; 14:3, 15; 22:23;
105:6;106:23;107:9,16, 47:3,6,10,10, 11;49:14; 23:16; 174:4 pinching 136:22 poIicy 914
22; 108:2,7, 16; 109:5,7, phfote192:16
50:24;51:1,8,8,12,22, pharrnacokinetk 22:5; politics 191:14; 193:17,
11, 17,21; 110:9,19,25; 23, 24; 52:2,3,5,6,7,8,9, pK72:12
08:25;892 19, 21; 2(XY8
111:6,9; 113:12,16, 21; 14,24, 24; 53:1,2,2,5,6, pharmecokinetks place 1915; 34:8; 57:4; polyhalogeneted
116:22,24; 119:8;120:9; B,9, 14,22; 54:2,7; 55:2;
126:3,3,5; 127:20,21, 25; 38:21; 3921 186:1;18922; 199:7; 167:14
57:24;58:4,4,8,11,18, pharrnecologkal 204:9;201X6
128:19;131:3;136:14; 22, 24;69:5,6,7,7, 10; pO~mSraSe 17:18;
137:6;138:3;140:2,3,13, 128:18,21 phced 19:17;198:15 18:24;19:13;20:3,7, 21;
93:4; 111:11;113:14; places 163:8
18, 19;141:3,7,14,18, pharmacology 14:24; 21:10;36:4; 161:17
117:13;133:5; 1507, 8;
24; 142:8,11,15, 19,25; 153:21;154:21; 155:2; 15:17;71:7 plain 123:21 pOOi 36:20
143:11,12,15,17, 17; 156:22; 163:1,17,19, 23; phase 33:25; 34:1; 89:7, plan 22:20165:6 poor 18:20; 116:12;
144:13,19,24; 145:1,12, 170:16,18, 25; 171:25; 8; 133:19; 165:6; 166:25; 156:13
plane 10:18
14, 15;146:3,6, 17;150:1, 19715 18017; 18914,15, 18; planned 73:10; 77:11, population 69:4, 14;
11,15,21 ; 151:1,6,6,14, 190:5; 192:21; 193:9, 12;
percentage 57:25; 5&2, 12, 13;78:19, 20; 80:7,8 101:16; 147:25; 162:3;
19,20,24, 25; 152:3; 194:23; 195:4; 1%:8, 9,
3; 120:8,9; 128:5; lXk25; planned-for 73:14 172:3; 178:21; 183:24;
153:22,22; 155:6;156:3, 21;197:1; 201:12,13;
197:2 193:2
17;158:15;159:1,23,25; 209:23 planning 194:11
160:7, 13;161:9,12,15, percentages 79:14,15, portion 177:5
phenorwnon 116:23; plans 10:9; 194:19;
16, 22; 162:6,9,17,18, 17,21,23,25 208:15 portraying 9:21
131:3
20; 163:1,12,17, 22; percentile 30:5;35:24 plasma 39:13,21, 23; pOSitiOrr 168:7; 183:4;
165:7;166:2,10,13,19 Philadelphia 9:22; 12:3 185:25
Perfectty 173:7;206:15 40:5
167:17;168:1,4; 169:13, philosophizing 181:15 positions %8
perform 174:8, 21; play 8:16; 148:7, 10;
15;170:10,11, 14,16,19, 183:12; 189:19 philosophy 101:16 positive 37:ll; l12:12;
25; 171:3,4,12, 13; 172:2; 187:23; 203:22
performed 69:9, 16; phone 112:2 117:3; 120:15; 158:6
174:14;175:2;182:2,7; piS@ 2616; 145:20
112:17; 113:8;123:13; phosphorothioete 17:3 positiiee 117:13, 19;
183:22;186:5, 12; 187:7, playing 128:10
17 192:1,4; 199:12, 14; 132:24; 140:23,24; phosphorous 17:4 120:8,10129:2,5
164:12; 189:14 please 11:22; 16:19;
=*5; 202:14;210:17 photo 25:11; 45:17; 24:19; 26:7; 32:1(J 34:17; possibilities 103:20;
nt$-85 152:11 performing 122:22; 118:14; 124:20 119:19
39:6; 43:23; 44:4, 25;
174:17 photo-a 90:15 46:21; 49:5; 51:2, 10; possibility 55:8;67:3;
k ,nts-or 127:22 perhaps 18:7;102:4; 78:10; 103:19; 132:25;
patients-thank 166:23 photograph 28:14; 52:15; 54:3; 70:23; 71:4,
110:6;112:13; 116:15; 76:16;82:9; 86:4,12, 17; 17, 24; 72:6, 21;73:8, :19; 133:5; 145:20; 169:21
patients-when 144:23 128:13; 140:1; 194:7,9; 90:17; 94:11; 109:20; 75:17; 77:5,15, 23;78:12, possible 46:15;61:17;
pattern 41:20 195:9;204:22 112:21; 114:3;117:25; 18, 25; 79:9, 19;80:1,5, 78:6;98:17; 103:25;
paui 9:20 perimetry 170:15 118:20; 119:10;124:10 12,15, 22; 82:18; 84:6,,6, 123:22;137:12;140:8;
patient’s - possible (24) Min-u-serimtm
Opthalmic Drug8 Subcommittee of the
Dermatologic and Opthdmlc Dmg Advi80v Crete Juiy 22, 1998

157:22;192:17 11:12;92:22; 100:8; wobabiiity 49:17; 53:6, 165:16;166:25; 171:23; protease-the 138:18
possibly 28:11;41:16; 01:7, 7; 105:20; 106:7,9, ); 55:1 200:2 protect 184:17
-—-. ,3; 122:4; 126:7,8, 10; wobabiy 31:6; 41:16; Jrogram-for 166:9
111.24;203:22 protection 177:23
.33:11; 138:24; 147:11; $3:18;66:25; 69:18, 20; arogram-was 166:10
post-baseline 139:22; Protein 16:6
.52:8 )2:16; 84:3; 97:17; 99:4,
146:10 wograme 14;!:11; 200:7, woteins 15:19,20,25
wesented 7:19; 10:3; 21;103:23; 105:23; [6, 17
post-HAART 60:12 wotocoi 28:17; 30:18;
.4:21;21:25;22:14; 29:5; ~12:20;116:21; 123:3;
post-NDA 152:20 mgreas 13:5,;87:14; Jl:l;33:22; 4020; 46:14;
\3:4; 59:5; 71:22; 86:13; [24:24; 129:4; 144:5;
post-randomization )2:25; 97:6; 115:24; 51:9;103:17; 106:21;
D:12; 93:3; 128:15; ~55:22;179:5; 185:3;
180:13 [27:15; 129:22;160:1 138:6;142:23; 158:24;
129:6;132:18; 134:10, 18; ~90:25;193:9; 195:13,20;
post-treatment 137:25 (40:7; 152:14; 163:14; [%:8; 19824; 201:20; wogressed 82:7; 87:2; 159:4;164:19; 165:5;
[64:24; 165:2, 3; 177:16; ~03:13 109:7,11; 116:4,19, 24; 168:2,24; 169:3
posterior 42:12, 16;43:2;
[81:9; 182:14; 183:2,8; [18:11, 15; 128:7,7; 140:4 protocoi-not 164:19
44:9, 24; 52:1 wobiem 18:22; 19:2,25;
[84:20; 185:9; 187:5; i3:16; 44:8, 16;45:12,18, Progressing !)7:5; protocoidefined 29:6;
postmerketing 180:16;
[90:16; 195:15 z4;46:ll,2q 73:13; 128:23;132:3 133:12
198:20,21; 199:5
tresented-the 93:3 116:18;117:16 137:10; progression 25:9, 16, protocois 47:6; 51:17;
potency 17:16
lresenter 13:22 164:7;169:5; 172:1,2; 12,25; 26:5, 19; 28:10,13, 142:18;169:11; 198:24
potent 17:10, 14; 139:15 23;30.4,9, 25; 31:2>4* 5,
]resenting 6:17 180:7 proven 44:22; 45:3;
potentiai 5:18; 31:8; 14,15,19, 20; 32:21;
xeserved 49:13; 88:15 wobiemetic 87:23; 52:22;55:11; 58:7
78:9; 85:22; 88:3; 89:14; }3:18;35:11, 17,22, 25;
>resident 14:9 )3:19; 127:13,16 Provide 14:10,25; 24:10,
103:19; 106:17; 169:18; 56:3,6,12,19,24, 25;
172:5 wess45:ll; %:24 xobierna 18:19;23:24; 24;122:9; 173:9
}7:5, 11,13, 22;38:10;
(6:16; 6&19 109:20; nrovided 5:16; 23:4;
potentially 59:11, 23; >ressure 43:4,5,12,15, $9:13;75:1;76:4;80:25;
117:14;122:17; 171:3; 107:22;108:6,23; 109:1,
84:18; 148:2; 186:6; [7; 44:6; 48:10; 163:15; 11:2,19,21,23, 25;82:2,
176:17;178:15; 179:1,2;
208:21,25 I98:1O,10 f;84:1;85:8,10, 12;86:9; f; 121:20; 122:13;123:6;
19015; 199:18;205:5, 24;
poten!’ais 10C:12 weasure-and 52:7 Z10:23 17:17;95:17;96:12; 124:9;199:6
xessures 43:7,9; 48:1 103:2;108:10;109:14; provides 17:7;37:16, 18;
power 66:12 >rocedure 63:15; 133:9; 110:4,25; 112:10; 114:2, *
pressuring 200:8 174:21 148:5
practice 137:9; 142:4; 11,12, 15;118:16,22,23;
146:19; 174:19; 184:12 wesumebiy 100:3; ~ROCEEDINGS 4:1 proxma 87:10
,-- 120:25;122:11; 123:5,7;
practiced 63:19 [33:18 xoceds 82:3 127:14;128:11; 129:19, psychological 11:18
practicing 14:11; 174:18 xesume 178:4 Srocess 15:24, 24; 16:7; 21,23; 139:19; 142:9; public 6:1, 12; 136:4;
.—= WSSllti 44:22; 84:18 ;3: 10;95:22; 124:7;204:9 15922; 160:3, 12; 161:11; 184:17;204:5,15
pray 175:11
xettier 79:7 wocess-i 204:8 163:2;170:17, 19; 171:1; publication 120:13;
pre60:ll
>retty 60:22; 156:8,9, 15;
174:10,12, 24; 175:1,5,7, 185:10,11
pre-existing 42:21; ~roduce 110:6 3,12, 17; 178:5,,12;
158:18 165:4;179:9, 11;201:3,8 publkations 134:1o
woducing 15:25 180:10191:2
pre-HAART 59:21;61:20 wevaience 92:18; 156:8, pubiiciy 205:23,23
product 12:13; 16:23,24; progression-he
precedence 61:13 14;162:21 17:1;71:9,10,16, 16; published 117:12; 146:2;
10!X12;111:151;152:17
xevent 16:6; 186:6; $2:15;89:5; 97:25; 98:21; 163:25
precedes 69:15 progressions 75:10;
187:17 ?9:2~ 125:21; 186:23; puil 154:4
preceding 50:10 78:2; 120:9, 14; 127:24;
wevente 177:25 1872,4, 11; 1%:14; 175:9 Pldkd 113:23
precious 182:1 197:22;199:12;200:12;
pWiOUS 6:9; 8916; progressive !54:24; purely 74:12; 132:2
precision 195:11 114:13;
183:23;
184:3; 201:23;202:25;204:5;
151:20 pureat 53:24
preclinicai 38:24; 39:16 208:10;
209:9 206:18
progreesors 128:2 purpose 84:10; 187:16;
preclude 5:13; 144:18; previously 14:7;21:1Z production 16:6; 17:1 189:6
145:19; 173:13 27:22;28:1,5; 34:25; Products 4:25; 5:3, 20; Project 6:16,:19,21, 25;
7:18;8:20; 11::15;13:25 purposes 151:8; 164:25
preciuding87:15 37:17;38:4, 7; 41:6,7; 6:9 74:3; 82:14; 98:10;
99:14,15, 16; 102:21; projected 73:18 pursue 23:ll
predictive 31:13, 19; 42:20;47:1, 3; 48:23;
55:15,25; 72:23; 111:10 186:10187:5, 24; 205:8, projecting 86:13 push 209:14
37:12; 139:19
predictors 137:23 159:23,25; 160:1;162:3 19206:10 projection 84:23 put 15:1; 17:21;36:2,3;
prke 194:20 profeasionai 23:12 promising 139:11 38:3; 42:15; 43:1; 44:6;
predominantly 47:23
primarily 45:19 52:18; profeasionai-i’m 51:14; 53:23;93:12;
preempttvety 44:12; proper 186:2; 195:9;
124:13 10&16; 105:18; 107:6;
48:15 88:16 199:6, 16; 210:19
122:7; 127:1; 136:16;
preface 139:10 prima~ 25:21; 28:9; professoi 22:15 properly 204:3 139:15; 165:8; 168:1;
33:17;61:12; 119:10; profile 2016,16, 17; prophylaxis 167:15 175:13;183:4; 185:3;
prefer 183:9
175:15; 182:25; 184:9, 21; 21:3; 47:17, 19;48:2, 20; 193:25;200:11, 14;
preference 13:8 proportion 1’55:2;
185:2,4; 203:3, 20; 49:1, 11; 54:8; 55:17; 203:24
prepared 106:17; 160:19 193:21
204:23; 208:1,23 161:3; 181:20; 182:12;
proposai 133:17 putting 180:2
preponderance 46:23 prime 88:15 184:7; 197:22
prescribe 187:11 proposed 70:24; 161:25
principal 174:4 profound 18:4, 5; 25:19
____ prescribes 19!):21 principles 204:14 127:16; 140:14 protease 7:8; 18:2, 14;
29:1931 :9,11., 12, 16;
Q
prescribing 186:7 printed 59:7 profoundly 167:21
32:25; 34:19; 37:13; 60:3;
presence 31:16 prior 27:20; 87:22; 89:7; Progam 167:15 qualified 63:15; 65:10,
92:3,3,5,10,112,13, 18;
present 5:18; 14:3,12, 99:12; 106:22, 24; 108:1O; prognostic 37:9, 11; 137:24; 138:8, 15, 18; 13; 107:9
19; 106:4; 133:15; 134:22; 112:10; 113:2; 114:15; 138:14; 141:17; 142:2; 140:14,22; 141:13, 14,18, qualify 1%:15; 198:20
158:22; 171:9; 178:20; 157:5; 161:10, 15; 191:15, 191:2 20; 142:2,7,8, 16; 143:2, quality 20:18; 57:1; .
183:18 16;195:1;203:5 program 15:10;22:19, 2; 146:25; 147:10,15,18, 116:12; 123:24; 124:2,3,
presentation 70:12, 17; privileges 207:12 24; 133:19; 141:21, 22; 20, 24; 148:4,“7,10 4, 23; 137:8; 188:19

Miller Reporting Company, Inc. Mmn-u-sel’hlm {25) rxmsihlv - mlalitv
Optha.lmiC Drugs Subcommittee of the
July22,1998 Dermatologicand Optlmls&c Drug A&Tisory Crnte
quantify 1%15 raise 207:19 readers 100:20;101:1; M!ClaSSifying 78:10 25; 51:3; 55:14, 16;65:7;
quarter 140:20; 154:20 raised 106:16; 174:7; 107:14, 15;111:19, 20; recognize 177:2; 186:1; 78:14,14,14, 16; 104:25;
~estion 1618; 27:13; 205:21 117:16;121:6,8 205:5, 1~ 206:4 105:2; 133:20,21,21, 24;
1;49:6; 53:4; 57:12, random 21:16; 101:9; readity 104:2 rt?COgniZed 119:25; 141:16; 142:1; 143:3;
J8:I; 59:14, 15;60:4; 114:9 reading 25:11, 22; 28:14 166:8 160:5,7, 12, 25; 161:1,2;
62:9; 63:16; 65:23; 66:18; Randomization 28:7, 18; 45:17; 74:15; 101:22; 165:16, 18; 195:6,7
recognizing 185:24
67:19;6&9; 69:25; 702; 33:15; %:3; 134:2,9, 25; 107:4, 10; 108:1,2,2,11, regimens 18:20,21;
75:18;85:14;91:23; 94:1; recollection 60:21;
135:1; 157:16; 159:5, 11; 18,19, 23,24; 110:11, 15; 116:5 34:20; 35:2,13, 23; 36:18;
97:19; 99:5; 101:12,15, 169:24; 170:6; 171:6 111:1,2,5,8,12, 16; 37:22; 80:4; 141:17;
20; 104:13; 105:16; 112:10, 17,21; 113:12,22 recommend 185:11.;
randomized 28:21; 34:2; 154:16; 160:16; 161:4;
118:17; 119:3,5,6,12, 12; 114:20; 115:11; 116:2,11; 19220
63:3; 156:2,3; 157:15, 22; 180:12; 193:11; 195:9
121:4; 127:18; 129:7,9; 117:2, 12,23; 119:17; recommendation 167:1
158:3,5, 18; 171:15; region 117:7,8, 17;
132:8,17, 22; 134:1; 120:5; 121:4;123:3, 15; 2; 189:12
177:11 130:25
138:22; 139:4; 141:5; 126:9; 127 :3; 130:16, 16; recommendations
randomizing 63:4 regions 65:6
14623; 147:12; 148:13; 131:15,21; 174:25; 175:6, 15919161:25
150:11,21,25 ;151:13; randomly 26:24; 27:2 7,8,16 regression 138:14;
recommended 13:1;
153:15; 154:5; 156:5, 10; range 33:9; 50:25; 52:3; 147:10, 17
readings 102:16, 16; 68:13; 168:10
160:21; 162:5; 164:8,9, 55:3; 152:15; 154:2, 21; 113:25 regular 210:15
recommending 22:10;
11, 24; 169:9; 172:25; 157:10; 166:10197:14 192:18;202:25 regulated 5:17
reeds 100:18; 110:12;
173:1; 175:25,25; 177:18; rangee 152:8 117:3;130:17; 131:12 recommends 71:9 raguiations 188:5
178:22; 179:14; 183:18, ranging 72:2 regU!atOr 16:24
red 45:24; 74:19; %:7; reconfirmation 111:11
24; 184:22; 185:8; 188:12;
Ransom 113:24 133:2;174:13; 186:3; reconstitution 68:9; regulatory 14:22;
189:13; 190:9, 24; 191:15, 184:15;186:12; 187:16
rapid 20:14, 25; 32:22; 187:16;200:17; 208:8 95:20
21; 194:21; 197:21;
199:13;201:8, 14; 202:17, 37:18 ‘SSiiti@B12:19 ‘SCOrd5:13, 24; 6:4; reimburse 186:10;
25; 203:2,7,15, 25; rapidly 30:11;36:9; ‘eahty 13:8 [1:2? 200:3,10,15
204:23; 207:25 37:21; 54:21; 160:2 UIization 13:4 ‘eCOrOed25:12; 42:22; reinduction 104 18;
question-1’m 172:24 rare 18:9;48:7; 49:18; [5:1; 81:16; 155:12 105:10
‘ealized 166:11
questionable 84:13; 52:11, 19; 53:5,7,9, 11; wcruit 13:4 ‘einductioned 104’15
‘eai~ 19:5;44:23, 23;
85:16; 105:24;202:16 66:2;166:1, 1; 167:9; ;2:12;67:9; 84:1; 86:15; ‘ecruiting 70:4 ‘einitiate 171:6
@eetioning 124:12
198:19;200:25 M:12; 98:15; 101:15, 25; ‘introduction 105:4
ecurring 73:13
rate 21:4;41:12;42:1; 103:5;104:17; 105:9; ‘eiterate 81:14
questions 7:25; 13:19 ‘SdUCSd169:15
_&*3; 15:11;22:7; 57:9,
i3:18;47:l,21, 21, 25; .16:8; 119:1,15, 18; ‘e[apSe 159:20
52:23;53:17;54:9;55:22; ‘eduction 8:7; 48:18;
9:2,4; 61:24; 69:25; 22:9,25; 125:2, 11;
125:8,18; 166:9 .10:18 ‘elate 152:13
. . ,L4;90:2; 95:12; %:9; .38:11; 144:24;146:~
rates 60:6; 120:1; 180:10 60:17,22; 161:5; 164:16; ‘edundant 134:19 ‘elated 6:6; 26:6; 41:16;
104:20,23; 105:12; 17:12;67:8; 68:7; 127:9;
112:22,25; 113:5; 127:3, rether 32:7; 63:4; 98:11, 79:1; 180:21; 183:3; ‘Emergence 55:8;
92:13, 14;195:6,25; 62:14 [39:8; 144:16; 151:15, 17;
5, 10; 132:10, 11;133:8; 13;102:4; 1%:2
9&22, 24; 201:5;204:1~ kens 6:14,16 .59:15; 162:5,23; 168:25;
137:17,19, 21; 140:6; ratio 24:6; 138:18,20,23, .71:14;188:13; 201:22;
148:6,15; 149:24;151:3; 23;147:6,9,11
!05:18;206:9, 12, 14; efer 24:21
!@:21,23 !08:2
153:1, 13; 157:12;159:14, ‘ationale 104:24 efereed 26:17
eason 67:1; 121:19; elating 149:17
18;160:8;161:20;172:19, ?etonivir 199:22 efSrenCe 132:19
19; 173:18 175:23; 27:24; 133:23;15%25; elation 122:20
paw%:19 65:21; lb6.zu; 199:23; eferred 63:24; 96:22, 23; ‘relationship 67:23;
180:20;181:12; 182:15;
w-evaluate 107:19 !06:11 51:4 ,46:8
198:16,17;201:19;
205:13,16 ‘e-SXaminSd 76:1; 111:7 eason-1 184:14 eferring 165:1; 199:1 ‘eletive 98:19; 187:4
quick 7019; 91:23; ‘e-pre$ent 106:8 eesonable 39:18; 55:8; eflect 69:14 ‘ehtiVe@ 64:6; 65:15;
95:11; 117:23; 120:7; ‘e-randomization 46:1; 178:13;184:2 eflecting 119:11 ‘2:8; 75:9; 78:1, 4; 82:6,8,
156:5; 199:8 L71:11 easons 11:12;73:16, eflection 104:9 t;88:6; 92: 11;97:6; 98: 16;
quickly 72:7, 8; 189:17 w-review 114:17 7; 106:19;117:5;124:20; egard 5:12; 37:22; 00:13; 103:8; 119:7;
quiescent 10:16 51:23; 164:15; 168:17; ,7:17,21, 22; 68:3, 8; 27:13; 171:24; 181:21;
wreviewed 94:19
71:21; 184:17 34:6; 149:10 165:17; 89:11;201:2
quiet 119:22; 128:8 ‘each 133:12; 174:1
Sessure 143:24; 174:20 84:18; 191:15; 206:18 eletively-well 12:15
quite 20:24;95:22; 98:15, cached 36:24; 89:8;
17; 111:24; 124:23; S@ 10$k20;144:8; egarded 170:17 elevance 130:23
[66:6
126:21;128:15; 129:4; :0911 egarding 38:23; 47:2!0; elevant 81:8
‘eSCtSd128:20
145:18; 157:14; 160:6,9; ecelve 49:24;89:14; 7:9; 94: 16;95: 13; 120:7; eliable 147:23
163:19,25;194:4 ‘wsctions 80:16, 17,20 39:7; 193:15, 24; 195:22
07:17; 150:6;195:7 elieve 148:5
‘eactivate-the 146:4 egardleSS 143:25
quitting 9:13 ecelved 6:25;9:6;33:2; e!uctant 6&24
eactivation 139:18; 9:24; 57:10;70:22; egarde 15:8; 18:7;
quoted 120:20 ety 180:9; 1%:3
!10:20 06:21; 124:3; 183:23; 9:15, 17;62:12,12, 22!;
quotes-unquotes 68:9 emein 13:13; 19:24;40:7
ead 5:8; 13:15; 25:10; 89:9197:12 33:24; 134:16; 138:14i;
!6:8; 100:14, 15, 16, 17, 41:7,20 emained 150:6;166:4; “
.———-
.. eceiving 9:4,5; 107:16;
R !0,21; 102:22; 107:14; 50:9 egimen 21:15; 27:20;
70:16
08:3, 21; 109:25; 114:6, 8:24; 33:16, 16,22, 23; emains 8:19;31:15, 20;
ecent 19:1,5, 24; 140:25
2;117:15; 118:5;121:11, 4:3,12, 12;35:8,9,9, 10, 64:4; 167:16
ra~bits 66:15 ecently 146:2
2,12, 13; 123:9, 10; 8,25, 25; 37:23, 24; 38:8, emerks 12:9;14:24;
rabbits-the 38:25 30:19; 131:18; 132:13; eceptors 15:20
,9,16, 17;42:7,8,24, 25; 6:23; 99:6; 100:6; 165:24
racial 69:6 88:7 Iecess 70:15; 135:9 5:15;46:12, 17, 18; emember 8: 18;98:13;
radio 166:21 eader 116:25; 121:12 Classified 110:21 .7: 14;48:2,3, 22; 49:1,2,
— 31:25; 156:18; 167:9;
quant@ - remember (26) Min-u-scz’idal M~er Renortim? Cnmnanv Tnc
Opthal.mic Drugs Subcommittee of the
Dermatologic and Opt.haknic Drug Advhory Crete J& 22, 1998

179:5 !1, 25; 19:23;70:6; ‘etina 39:1,5; 67:7; revisit 24:7 67:21;95:3; 123:1;
remind 4:7; 51:22; [62:11, 14; 163:11, 18,20; 33:16;113:24; 117:8, 18; rid 178:2 126:15, 18;129:23;
n 108:19; 109:21; 11O:23; [64:5; 193:3 130:8,11;131:1,6; right 12:20;42:8; 57:19; 140:11; 142:3,5; 157:15;
152:10; 168:5 ‘esistant 8:4; 17:6, 17; 172:11;1%:24 74:22;81:1; 84:11,17; 165:24; 167:7;179:6;
19:1,9; 21:9; %:19; retinal 17:12; 19:2G 21:3; 101:2; 105:17; 117:17; 190:21; 194:22; 199:9;
reminder 71:5; 109:3
163:21;186:21 25:17;33:12; 34:15; 123:20; 137:9; 138:5; 201:25;205:23; 208:4
remissions 18:4
resolution 42:1; 43:18; 37:14;39:19; 41:12; 45:3, 140:10; 143:6; 145:11; salutary 15:22
removal 41:11 5, 19;47:1, 20; 48:5;
f4:5; 47:25; 54:9; 81:20; 146:11; 152:8; 154:13, 17; salvage 187:13
remove 66:5; 145:1; 52:17,17,18,18, 23; 157:20; 162:1; 164:2;
152:3 same ll:2;29:21; 30:18;
146:22 54:25;55:1, 21;83:12; 167:3; 185:22;205:17;
resolve 41:9; 55:20; 31:17;32:18; 34:4;39:13,
removed 10:7,8; 144:13; 98:3;98:8; 114:18; 207:15 16;43:25;46:3;49:24;
71:13;146:11
145:24; 146:18 117:21; 150:12, 13; rigorously 209:3 SC.18;51:3,5, 14;52:16;
resolved 43:13;44:7, 9;
renal 20:4 151:24; 152:1; 153:3; 55:9;62:2;73:24; 75:14;
71:12; 190:14 rises 32:7; 43:15; 146:6
reopened 171:20 169:1,4;170:1,3,4; 77:25;80:2, 4; 83:14; 85:5,
resolved-1 652:8 172:5, 14; 197:7,10, 14; risk 7:12; 19:119;165:17;
reopening 171:15 181:15; 1%:1 9;86:6,17, 22;87:7;
resolves 82:3 198:8 97:19; 102:10; 108:23;
repair 152:1 risk-to-benefit 24:6
respect 5:25;6:7; retinas 39:17 110:11, 11;113:16; 123:6,
repeat 56:1; 164:3 149:17; 188:14 RNA 16:2,4,9,17,17,18,
retinitis 7:15,21, 23;8:6, 9; 125:24; 130:9,15, 22;
repeated 41:13; 132:19 respectfully 95:12 20;9:12, 18; 12:20; 14:6; 22 134:12; 136:22;145:9;
replace 133:20; 165:17 respectively 30:6; 41:8 15:7; 18:7; 19:9; 20:13; Roche 130:19; 167:14 146:16; 153:15;155:9, 17;
replication 16:25 21:18,20; 25:17, 18; role 26:16; 5923; 68:1~ 157:4;161:1, 21,24;
respond 33:4; 62:3, 6; 164:19, 19; 168:7; 170:22;
report %:16; 134:10; 66:23; 130:5; 191:13 26:14; 27:18, 21; 28:5, 10; 145:~ 148:7,,10; 187:22;
29:17; 3025; 31:14; 203:22 173:12; 17918; 180:24;
148:19;
163:24;
191:23; respond-who 92:25 183:1; 186:20;188:22;
197:17 32:21; 33:9 34:15; 35:24; rollovers 51:18
responded 128:1 37:17, 18;38:14,18,19 201:8;208:9,9,14
repo*@d ‘17;6:1; 19:1, room 7~19; 1.95:8
responder 14o:1 41:5; 45:22; 5022; 54:17; same-within 13o:9
22;2>.Lu;91:10;43:3; roughly 58:8; 140:20;
responders 30:13;93:1; 55:8, 13; 56:7, 11;57:4; 150:20; 154:20 sample 92:l~; 93:7;
46:23;47:18; 53:14; 54:9; 101:24; 104:9; 132:20;
58:5,9; 112:12; 123:7; 110:20; 144:16 65:17;68:2;6913; 707;
round 114:21 138:10; 164:15; 179:24;
133:13;138:9;163:3; responding 116:25 71:2;74:3;81:2;82:14;
,--
83:9,10,17,21, 24;84:15, routine 27:7; 4024; 74:2; 188:14; 192:11; 198:18,
164:1;172:15;175:17; response 12:7;48:13; 146:19
15;86:14,23; 87:2,14; 18; 200:24; 204:11,12
177:20;197:15 62:20; 66:19; 68:20; routinely 140:23
88:17, 18;90:20, 23;91:2; sample-even 179:2
.-= reporting %:17 105:14; 113:3; 127:7; 95:8;97:3, 22;99:8, 14; row 82:23 samples 39:23
reports 43:12; 45:17; 136:6; 146:7; 195:17; 125:21;131:17;139:15;
200:20; 202:10; 203:16 Roy4:19 sampling 100:6; 101:9
58:8;60:8; 156:12; 157:2; 143:22;144:12;148:24;
162:23 responses 62: 10;93:5; RPE 45:10, 1:2;52:19 San 6:16; 146:2; 162:24
151:2q 158:6161:23, 23; 106:17; 16916; 170:2, 15;
represent 19:2;62:2; 140:5, 14; 195:18 162:2,15, 21; 163:5,7; satellite 83:21, 23; 84:1,
171:2, 23; 172!:7,16 2,4, 1%85:11, 19;95:3;
65:3; 152:6; 153:6; 169:22 responsibility 124:17 164:8;165:25; 166:17;
174:9,11,15, 23; 176:3; rule 16921 117:7,14, 17; 120:18,23;
represented 107:19 responsible 22:19;
23:23;144:22; 172:16 178:5,12, 19;185:4; ruled 89:20; 1[86:18, 19 129:9,10,12,16,18,20,
represents 103:5
187:25;195:7;202:14, 16; rules 188:5 24; 130:23
reprieve 56:17 responsibly 173:11
210:14 run 80:13; 92:11 satellite-potentially
reproducibility 123:18 rest 119:22; 175:3
retiring 22:21 runs 197:15 65:19
req. ‘St 209:5 restoration 208:11
retrospect 169:3,19 satellites 116:14; 117:18;
requested 8:25; 106:8 restrict 106:10; 18@14
requeets6:13 restriction 209:9
retrovlral 163:14
return 38:11; 132:12
s 130:7,10, 25; 131:6,9
satisfactori~ 198:12
require 19:14;63:13; restrictions 194:1 satisfy 147:12
reversibility 1%:25
65:18;82:21 resuit 7:11; 8:9; 12:14; Sadeer 12:2 save 19Y1O
109:1%110:11; 160:22; review 12:22; 13:12, 15;
required 34:9; 41:ll; SSfS 7:20 22:9; 24:12;
saw 13:9;39:16; 50:10;
165:14 22:11;23:4; 27:1041:1;
44:20; 146:8; 180:17 40:11;41:5; 97:21; 56:7, 10;67:7;84:22;
48:9; 7019, 22; 75:22,23,
requirement 19:18 resulted 18:5,20; 110:18 171:17; 188:1 87:13;91:9; 95:6;97:3,9,
24; 76:13,19, 22; 77:25;
183:12 resulting 112:6 78:22; 79:8; 87:12;89:11; SSfS~ 97:21 20; 121:9;126:6; 144:15;
requires 63:16; 177:10 results 22:4; 29:8; 67:20; 106:21; 107:17,25; 113:7; safer 88:1 145:9;147:11; 166:8,8;
reread 106:25; 108:4; 72: 17;77:22; 106:12, 15; 125:17; 127:22 Safety 6:4;8:1; 14:4, 12; 169:14;170:12; 171:18
113:24; 114:1,13, 19,23, 10923; 1106; 114:20; reviewed 26:11;73:23; 20:16, 17;21:3;22:2, 25; sayll:12; 13:13;32:19;
24 123:13, 14,25; 130:15,15, 77:4; 9719 114:4; 23:5;24:5;27:5;38:23; 42:15; 47:17;81:25;82:2,
rereading 108:2o 15,20, 20; 133:16; 161:5; 125:20, 23; 126:17 40:11,14, 23;,41:14; 4,5, 5;83:9;87:19, 25;
166:8 47:17, 19;48:2, 20; 491; 95:8;97:16;99:25;
Research 5:18; 11:13, reviewer 81:21,22 ;82:l;
14, 15,25; 12:1; 19:4, 5; resume 116:2; 135:7; 102:5 54:4,8, 12;5!5:17;56:24; 100:17;102:8; 103:3,23;
22:2o; 23:14; 56:6, 13, 18; 136:3 62:12,15,19, 21;73:2, 5, 112:8 122:5; 129:18,20;
reviewers 82:2; 84:5; 131:18;136:8, 15, 18;
117:2; 123:12; 130:18; resumed 116:11;118:12 6;89:4; 91:19; 97:17,18,
102:10; 108:24, 24; 111:8; 154:17;161:8; 166:3;
.—-.
168:2,4; 205:18 resurge 19:9 19;98:9; 127:2; 133:24;
115:1 175:1;180:24; 181:4, 17;
161:3; 165:13, 17; 167:2;
reservations 176:5 resurgence 19:7;70:7 reviewing 81:6; 83:24; 183:3; 187:19;189:17;
168:9 169:1.7;181:2Q
resident 192:4 retain 151:1 185:9 182:12; 184:”7;190:4,9, 193:18; 195:24; 196:21;
resides 35:23 retained 55:20; 113:22; rSVk)WS %: 10; 126:24, 10;193:10, 13; 197:22; 199:23;205:19, 22; 206:7,
residual 15:6; 20:12; 153:23 24 198:16,17, 22; 199:4,5; 20; 208:16, 18;209:1,8,
146:9 retains 17:16 revised 150:3 201:22 24.24:210:1,9,11
Resistance 18:12,14, retention 50:13 revisions 46:14; 185:12 said 15:15;4[8:14;58:22; I say-you 124:5

Miller Reporting Company, Inc. Rlin-u-scril)ti {27) remind . sav..vnv-
Opt.halmic Drugs Subcommittee of the
July 22,1998 Dermatologic and Opthaknic Drug Advkory Crete

saying 9:3; 53:25; 101:5; [02:17; 106:4; 108:25; 108:14; 115:13,16,21,22, 40:4;47:24; 55:15; 60:2; 204:12
122:24; 125:2,6; 139:10; 114:14,18; 116:14; 25; 120:11; 132:1; 146:16; 67:5; 118:14; 121:24; skew 152:17
--:9,10, lJ, 11,204:8 118:11;121:24;126:11; 186:4 122:7; 129:8, i43:5; ddpphg 71:20; 80:6
s 128:11; 149:20 128:22,25; 129:16,20; Bets 100:25; 108:4; 152:10;174:11
sleeping 197:24
. . wring 83:6, 8; 117:10
132:14;134:4; 135:5; 111:7;114:1; 115:14,17; showing 40:11;87:8;
138:21;140:16; 143:9,12, slide 15:14; 16:19; 17:9,
116:1o, 12; 118:4; 126:20 145:22;204:23
scars 95:8; 131:4,5 20,23; 19:11;20:1, 11,13,
14,16;144:19; 145:12; seven 110:15 shown 715; 12:18;
scatter 31:23 148:11;152:15;154:19; 22;21:11,24; 22:1,6,13;
Seventy-three 37:2 15:18;1812;22:1; 54:10; 24:3; 2621; 30:1; 32:14;
scenario 49:16; 51:11; 155:21,22, 25; 163:4; 127:19; 139:12; 160:10;
52:24; 187:10, 15;208:12 166:17;169:10; 170:8; several 6:5; 12:15;25:20; 33:6,8; 37:1; 50:10, 16;
26:17;35:3; 42:13; 43:7; 166:16; 171:8; 182:1?); 56:2;61:25; 64:9 68:22;
scenarios 186:23; 2@7 173:7;174:12; 175:14; 191:2
178:17;181:19;189:6; 49:8;72:18; %:21; 70:23;71:4,17, 24; 72:6,
scenes 9:22 127:20; 141:25; 162:8, 23; shows 27:25; 28:1; 21;73:8, 19;75:17; 77:5,
190:8,9; 191:5; 193:3,6;
schedule 21:22; 33:7 197:1,2;203:6; 209:15; 163:6; 177:10 35:12;74:14; 78:4; 156:6; 15, 23; 78:12,18, 25; 79:9,
scheduled 39:8; 87:22; 210:5 several-some 177:14 163:15; 184:20 19;80:1, 5,12,15, 22;
157:4 shrink 10:22:209:2 B2:18;84:6,21,22, 25;
meing 45:21; 5016; Bevere 41:10; 44:1; 58:7,
schedules 21:21; 22:9 shrinking 101:17 B5:1,22; 87:10, 24; 88:11,
103:20;108:7; 11024; 23;157:6 24;89:10, 23; 108:1~,14;
scheme 28:17; 33:22 125:25;126:2; 144:21 severely 56:7 side 10:5; 18:18; 20:5;
21:4, 13; 188:22,23, 2!4;
110:8, 10; 111:3, 17;
science 103:16; 125:13; wek 182:3,4 severity 43:24;46:2, 22; 138:21,23; 139:1,2,6;
148:25,25; 149:1; 191:14; waking 13:13; 182:7 189:1
i7:15 145:7;147:6,7,8; 150:2,
193:17,19, 22; 205:4; warn 169:5 sight 101,8 19;151:4; 152:7, 10;
sex 29:15; 134:19
206:3,3,21; 209:12,13, seemed 48:17; 145:17; signal 133:25 153:4,12, 16;154:4, 14;
shadow 28:12
14;210:9,11 164:14;169:23; 191:10; ~ignifiiance 88:9 159:21;160:6, 11;169:10
shaking 210:10
SCienCeS 123:10 1%:20 signHicant 29:8, 25; dide-1’m 143:13
shameful 185:19
scientific 13:21;22:22: seemingly 3918 31:15,2~32:z+; ~7:21; slides 24:21; 26:11;
~hameless 193:25; 38:13;54:IJ, 60:1; 72:9;
96:7; 125:1; 179:22 seems 61:6; 147:16; 29:14;42:3,5; 73:21,23;
194:3 79:16;83:25; 88:21;
sclera 66:6 148:2;163:20; 179:8 74:12, 15;76:16; 77:4;
shape 18:3 107:23;151:18; 185:12; BI:4,9; 82:24; 83:24;84:6;
scope 174:18 wan 23:2;45:13;66:1$? share 24:2; 27:14 192:9
58:25;70:8, 24;85:18; 97:3;100:21,22; 113:22,
, _acore 82:3, 16; 115:19; she 6:14; 10:3; 114:1,19, signifkantly 31:19; 23; 114:8,9 115:5,6,8;
118:20,25;121:20 )6:25;97:23;98:6, 23;
100:8;126:1; 138:24; 22 35:14;79:14; 126:5 116:9,10,15, 18; 121:24;
score-any 118:19 she’d 181:16 similar 32:1;34:6; 351:19 122:4,25; 123:10,21, 23;
163:8;164:4; 172:17;
=-%ed 45:17; 116:19; 36:13, 18;39:19; 40:4; 124:23;125:20; 129:8;
184:20;192:3;210:18 ~heet 118:2
10 56:15;62:10, 20; 80:13; 136:14;138:10,24;
Segregated 177:3 sheet-or 118:1 150:16;153:2; 190:13,16
~res 28:15; 33:20; 55:6 ?8:17; 123:13,14, 15;
selected 79:10 sheets 115:8 130:20; 145:19; 156:9, 15; slides-what 190:13
scoring 46:2; 82:12, 13;
118:19;122:12 Sense 30:11;38:22;%:1; short 75:ll;78:l,3; 161:4; 175:15,17 slight 81:15, 19; 156:16
37:18;98:11; 104:17; >8:15;121:3;151:7 5imilarly 44:8
scratch 114:22 slightly 74:24; 86:21;
L1o:6;140:3; 177:18 ~hortcomings 18&21;
se&l15 simply 56:1; 101:9; 122:16; 129:12; 130:2
sense-l 122:1 192:10 118:19,23; 134:13;
Seattle 64:23 slot 136:17
sensitivity 32:2, 11; shorter 110:22; 161:11 147:24;160:4; 189:5;
second 30:24;85: 1; slow 97:14
144:14;145:21 shortly 144:9 190:25;209:15
108:21; 111:8,2~ 113:7, Sent 107:24 SIOWSd97:8
12,17, 19; 114:19; 116:18; should 6:1; 8:5; 11:11; since 7:4; 22:23; 36::18;
SMSi[ 7:18, 22; 12:23;
1393; 157:25; 189:7; sentiments 204:21,25 12:18;19:8;40:12;49:2; 42:13;99:22; 144:14;
63:7;72:4;76:6;77:24; 13:2; 14:23; 15:18; 39:11;
207:5,24 separate 130:11; 133:10; 160:5; 164:18; 171:10;
84:3;89:6; 101:8;104:15; 67:11;70:4; 74:23; 75:9;
181:12; 189:6; 200:12 179:7; 185:16; 1%:3;
second-that 182:13 118:18;124:2Q 125:3; 78:4, 8; 79:22; &l 19;82:7,
separately 99:9; 121:13; 200:21
second-line 99:7 130:6;141:16;148:23; 8; 84:17; 87:15; 89:11;
155:13; 179:1% 181:14; single 36:14;37:19; :39:9; 90:2; 91:13; 92:8, 16;93:7,
Secondary 25:24; 1802; 149:1, 1; 164:20;166:13; 40:6; 62: 1;79:24; 82:!?;
182:16 20 %:6; 97:18, 25; 98:5,
182:25;185:3; 208:23 177:1; 181:12,14, 23; 108:8,21; 118:1; 145:13
sequence 16:22 25; 103:5, 24; 116:22;
Secondly 23:19; 150:12; 182:15,25; 183:3;184:8, sit 103:9; 210:1
Sequenivir(ph 199:22 18; 186:24,25; 187:13,13, 117:8,9; 127:14; 128:25;
160:4 130:2; 132:20; 136:24;
sequentially 107:14 22; 188:2,7; 189:14; sites 1%:5
secret 168:8 138:10 172:3; 176:16;
serial 142:23; 143:4,9 191:9, 17; 193:22,22; sitting 98:13; 124:14,;
section 27:16 181:16;210:10 198:18;200:25
serially 142:15,17 194:2,22; 195:7;1%:7;
sections 88:19 204:5, 14;205:1,9, 25; situation 118:13, 16; smeller 98:23; 101:17;
see 9:7; 11:4,5; 13:9; series 16:5;42:5; 61:24; 146:6; 198:18
208:19 191:3;208:14
21:13, 20; 24:18, 22; 115:13; 132:9
shoulder 35:10, 20; sttuetions 180:24 Smith 9:1,1,2, 2; 136:8,
27:16; 29:5, 13;30:2; 32:6; serious 59:1 13, 13; 137:14, 15; 148:18
16m15 Six 9:8; 43:21; 52:13;
35:9; 38:24; 39:2,2, 14; serve 7:7; 186:4; 187:16; Smith’s 150:23
shouldn’t 187:1;203:12 77:18, 18; 140:12; 152:11;
40:17; 41:4; 42:4; 45:6; 201:21; 206:14,16
show 9:22; 21:8; 26:22; 163:3 smoldering 119:16, 18,
48:17; 51:14; 56:15; 59:7, served 6:4; 125:15; 185:7
297, 21;30:14; 31:12; sizable 8:19; 23:22 24
.-—-~:7, 21; 62:9; 68:22, serves 6:22; 185:21
;9:5,6; 75:11,12; 32:2, 12;33:9; 34:21; SiZa7:18; 24:8,13, 15, 23; Snollen 67:15
; 77:25; 79:13; 80:13, Service 12:3 35:11;36:20;37:1; 41:11; 25:13;53:12;54:5; 55:22; S09:25; 10:1;11:9,9;
.u;81:12; 82:24;83:8,12; session 13:22; 136:1 43:18; 49:11; 52:16; 78:2; 92:16;93:7; 101:24; 13:17; 16:12;29:13;
84:16,16,17, 22; 85:18, Set 22:10; 24:8, 13;42:3; %:25; 152:7; 153:21; 104:9;132:20; 138:10; 38:11;42:3;44:23; 45:5,
19,21,21,22 ;86:7,8,19, 43:25; 49:17; 50:12; 154:14; 172:6; 175:4; 164:15;171:5; 179:24; 24;47:9; 54:4;57:24;
20, 23; 87:3, 5,8; 90:20; 53:12, 19; 54:5, 12; 55:22; 207:20,22 188:14;191:6; 192:11; 60:12,17,18, 23;61:4;
91:1; 94:6; 95:5; 101:24; 68:5; 77:7; 89:22; 103:24; showed 32:14; 39:20; 198:18, 18;200:24; 62:23;63:23; 64:6;66:3,

saying - so (28) Min-u-scl’hm
Opthai.mic Drugs Subcommittee of the
Dermatologic and Opt-halmic Drug Advisory Crete July 22, 1998

15;6?:9, 13;68:5, 10; 102:22,23; 103:1,20; speaking 6:17; 177:9 starting 37:20; 74:8 stratification 134:15
69:18;70:11, 14;73:5; 104:23;106:8; 109:3; special 206:18; 207:11 state 60:25; 65:7,9, 12, streaks 85:21
:—.. 74:23; 76:21; 79:24; 112:1, 14,22; 113:25; specialist 113:25; 15; 124:8; 199:19;200:1 strength 105:20
81:20; 82:8;84:19, 23; 115:2,8, 10; 116:9,15, 20; 114:19 state-or 1901:20
85:6;86:4;87:8;89:1; 117:19; 120:25;121:19; stress 13:14
specialists 63:21 StStSd 40:25;,70:24; strict 61:15
93:7;95:24;%:16, 24; 128:17,20; 129:8,9,10,
specialize 63:21 190:20 strikea 201:6
98:16; 100:18,25; 102:5, 15,20, 23; 133:15, 16;
10, 14; 104:8,25; 108:3, 134:9; 135:3; 136:16; species 66:21,22 statement 5:954: 15; strong 67:6; 147:1
16;111:4; 113:14, 17; 137:22; 141:16,21; spedfk 39:11; 63:14; 60:25; 100:2; 101:4
strongly 54:13; 168:15;
114:5, 16;115:10; 116:4, 142:25;143:2,12, 16; 138:22; 139:2; 141:16; statements 179:16; 185:14
13,15, 17;117:18,22; 146:12; 147:2;148:5,9 153:13; 173:18; 183:2 203:24
struck 9:25; 201:2
118:3,22, 25; 119:1, 18; 151:22;152:18; 156:25; specifically 168:23; Stek!$ 11:7; 1[2:20;64:18;
120:18;122:21, 123:17; 157:24,25; 160:18;163:7, 1%:10 StHJCtUre15:21
162:22; 192:2, 5; 200:9
124:22,23; 125:10,18, 22; 11; 164:17;166:2; 168:8, specknens 163:12 StWggh 205:3
stating 180:4; 181:3
128:9;130:13,20; 131:8; 25; 176:8, 17; 177:17; speculate 202:18 StW@iflg 205:11
statistical 32:13, 16;
133:7;135:3,7; 136:24; 188:5;1891, 10; 191:10; spend 15:3 studied 12:23;89: 17;
93:21; %:14; 100:2;
137:12;138:10;139:21, 192:9, 19; 195:9;1%:9, 133:8; 134:13, 14; 135:1; 166:12; 180:5; 183:22;
spent 160:9
22; 140:2,3, 13,21; 22, 23; 1977; 201:20; 191:22; 204:13 1%:24; 208:9, 11,21
142:16;144:7; 145:2; 203:4,9,10,10,11, 15; spin 208:7
statistically :29:8,20,25; studies 6:6; 7:14, 24; 8:9;
146:5;149:19;150:11; 207:8;208:22 Split 180:23
31:13; 35:13; {37:23; 21:14,25 ;24:21;39:16;
151:8,23; 152:23;153:8 somebody 119:4; spoke 67:20 40:4,9, 21; 43:21; 46:9;
155:16;157:11, 16; 159:5; 38:13; 54:16; 793, 16;
134:11;210:15 sponsor 7:24; 12:16; 47:22; 63:3; 69:9, 16;
160:2,21; 161:2,7,12, 19; 80:14
someone 65:13; 178:1 13:1;71:13;75:25; 87:18; 71:18, 22; 72:8; 73:13;
162:25;163:4;164:1, 15; 903, 12;93:3; 106:3; statistician 101:5; 177:9;
something 9:17; 45:6; 179:4 78:6; 87:21; 88:2; 89:6;
165:11;166:24; 167:19, 126:7,8, 20; 137:19,22;
21,27: 10ZJ.18,21;169:1; 47:13; 54:18; 5919; 60:4; %:2, 10, 22; 104:14;
148:15; 149:24; 180:12; statisticians %:18; 107:3; 121:21; 123:10, 16;
172:13,i74:ll, 13, 19; 63:6;73:20; 75:1; 92:22; 184:8; 190:24; 191:19; 179:7
124:15; 128:22; 131:14; 126:2; 13019; 131:2;
175:8, 16; 176:9;177:17; 209:1 statistics 158:14; 179:6
141:19; 146:5; 150:15; 132:13,18,1$, 22; 133:10,
178:22;179:8;180:16; sponsor’s 77:1; 90:11;
162:20; 167:7; 184:12; status 165:5 20; 134:2, 22; 140:4,18,
182:7,9, 16; 183:1,2,4, 92:21; 100:8; 106:7;
,- 186:7; 187:19; 19014; stayed-was 144:3 23; 141:3; 142:12,22;
13,22, 23; 184:24; 185:2, 179:24
194:10; 198:25; 199:9; 146:20, 23; 161:6; 164:12,
12, 17; 186:11;188:9,15, Stein 26:9
200:11; 201:6; 210:22 sponsor-and 73:15 17, 18,24; 165:2,3,21,
.———.25; 189:1,3,21, 23; 190:6, sponsors 162:13; 178:4;
step 15:23; 54:20; 23; 166:18,20, 24; 167:10,
10, 16;192:17,20, 23; sometime-widespread 187:19; 199:116
59:16 179:12 13, 16; 168:4; 170:7;
193:12;194:12,17, 17,21; stepdown 64:21
spontaneously 43:13 171:20; 180:16, 17;
195:19,24; 196:3,25; sometimes 85:6; 116:12; Stepped 23:10 182:23; 183:1; 189:14,14,
198:19,20; 199:2,21; 121:15;124:19,21; sporadic 157:2
steroids 48:13 15,19,22, 25; 190:6,8;
200:4,25; 201:1, 13; 157:1~ 168:6; 199:15; sporadically 142:20
eticke91:ll 192:16, 18; 193:5,9;
203:5,12, 17;204:22: 205:8 spot 86:23; 115:9 195:4,10, 21; 1%:8, 15,
205:17,17, 21;206:1,4, somewhet 55:ll;6921; still 8:18; 11:1.6;13:12;
spots 122:21 23; 199:1;201:10
11, 18;207:13;209:13, 13, 112:4; 134:23; 152:16; 30:8; 31:3; 65:15; 77:2;
23;210:2,6,12 square 39:2 studies-and 38:24
159:21; 165:17; 180:1 91:8; 92:15; 9:3:6;%:1;
SOCA 55:2; 117:2; Squibb 167:12 105:22; 113:21; 115:19; studies-we 166:24
somewhere 93:4;
120:20;123:12; 130:18; stability 17:7 116:1; 136:22; 137:13; study 10:11, 12; 11:8;
197:15,17,20
189:24 stabilize 163:20 145:2; 146:25; 150:9; 12:21;18:10;21:15, 20;
soon 10:8;142:24 152:24; 154:21; 156:22; 22:5;24:21, 24; 26:5;28:4,
social 205:5 stabilized 67:5; 143:19
sooner 116:19 176:7; 179:18; 180:24; 8; 29:2;32:9;39:7, 12;
society 205:5 sorry 68:24;7920; stagei7:l l;61:18,19; 197:7; 199:4 41:11;42:18; 44:10;
sodium %:25; 97:21; 139:2;143:13; 145:8; 131:7 5023; 51:7,8, 23; 52:11;
stippling 45:10, 12;48:5;
176:2; 179:10 151:13;154:9,20; 155:1; stages 705 53:21, 24; 5920; 60:6;
52:19; 106:17; 169:1,5,
solely 1%:3 158:20;1698; 17024; stand 9:7; 32:7; 136:18; 16; 1702, 15; 171:2, 24; 70:4, 5;71:25;72:1,2,12,
solid 117:7, 11; 161:14 172:24; 173:1;17%7,19; 160:19 172:17; 197:7 14,16,17, 20;76:17;
SO~ 15:22; 17:23, 23; 197:24; 199:10 standard 25:10; 27:8; stop 75:13;l168:15; 77:20; 89:1; 106:25;
18:24; 19:15;27:14; SOrt 38:21; 59:18;65:21; 67:15; 74:1; 93:21;100:3; 178:23 107:2,23; 110:7; 111:12;
30:14; 38:3, 23; 40:1% lo5:a 197:1 105:4; 130:22; 131:11,11, 112:7; 123:8, 13;125:1;
StOppSd 61:4[;87:15;
44:10; 45:5; 47:12; 48:8, sorted 190:5 13,22; 139:16;177:12, 19; 133:4; 142:9; 143:15,22;
97:5; 119:21; 128:7; 144:1,3, 18;145:15;
14,15, 16; 50:2, 10,21; sought 23:11 189:20,23; 191:22; 192:1; 166:24,24; 167:1; 168:12;
51:24; 53:23; 55:5; 56:10, 199:24 149:14; 150:6; 151:7,10,
sound 204:13 1%:22
14;58:11;66:8; 67:4; standards 176:21 11,12,14,19,20,21, 24;
sounded 141:5; 142:5 stopping 168:6,10,18 152:14;153:9,10, 17;
68:12, 20; 69:20, 24; 70:9, standpoint 189:10
11,20;71:7;73:9, 16; sounds 64:24 stored 163 158:19,24;160:13;
74:17,19,25, 25;75:5, 15; stert 4:6,9; 9:3, 10;60:7; stories 80:23 161:13, 14; 164:3,20, 21;
source 116:13
77:9, 9; 80:25;81:7,9,11, 88:25;91:5; 106:19; 165:9, 11,11, 15,19;
sources 100:9; 101:9; story 46:8
_e. 13, 14;82:19,21;83:4, 5, 151:4; 175:24; 189:15; 167:3; 168:6, 12,14,16,
140:8; 162:19; 163:6,7 1%:17; 201:24; 207:24 straight 35:17;75:9;
19,19, 22;84:12, 24;85:3, 84:16; 129:25
18; 171:5, 15; 175:2,4, 18;
South 69:8,10,11 started 44:12; 46:14; 182:24; 188:10, 17;
7, 10,11,11,14,14, 15, straightforward 207:3
18,20,21,21, 22;86:2,9, spans 59:21 48:14; 61:3; 74:7, 11;76:7, 190:21; 191:16; 192:10,
19,19,22,23, 25;87:1,9, speak 4:8; 6:13; 8:23; 18;78:24; 107:1; 114:22; strains 8:4; 17:17; 19:2, 13,14, 21; 194:25; 195:20;
13;88:3;89:2; 92:1, 2; 12:6;60:1; 94:24; 136:5; 120:20;132:23;140:22; 9; 163:22 1%:21; 197:8, 11; 198:21;
94:17, 18;95:3;%:1; 97:5, 173:25; 177:7 143:17;164:21 stranded 16:4 201:12,13
17;98:1,7; 100:23,24, 25; speaker 8:25; 49:12 starters 109:5;140:12 strategy 17:2 ShJdying 101:17; 188:22

Miller Reporting Companv. Inc. lMiss-lJ-SdntUO
Opthalmic Drugs Subcommittee of the
July 22,1998 Dermatologic and OpthalmDicDrug Advisory Crete

stuff 136:lfi 176:1; 178:11; 189:3; 139:17;162:8; 163:12, 17; terribly 161:3; 172:1, :1; 60:1,1,4,6,13,15,16, 19,
style 57:1 202:14; 208:23 184:10; 193:22 179:8 20,22,24, 25;61:1,8,15,
~-hreshold 116:22; SUppOttSd 189:12 takes 74:24; 117:25; tests 27:7; 40:24; 135:1 21;62:1,7,9,9, 14,20,23,
) supporting 189:4 204:9 Texas 19!):19 24;63:2,2,3,6, 16;64:3,
taking 1025; 67:22; 4,6,8,16,17,18, 24;65:3,
S. =ommittee 4:4 Supportive! 105:22 than 17:14; 25:3,4,5, ‘5,
174:13; 201:18 4,17,21, 24;66:2,3,9, 12,
subgroups 92:10 SUppOrtS 48:21; 54:14 7;26:11; 33:11;34:8,9; 19, 24;67:3,6, 14;68:5,7,
subject 11:1s; 202: 2; supposed 10:13 talk 12:13;27:17; 38:20; 36:22,23, 25; 37:5,6, 23; 11,11, 14,15, 19,23;
206:4 49:10; 5012; 51:11; 38:9; 43:7; 49:8, 12; 50:7,
suppression 20:4 69:5,15,18,20, 20;70:5,
63:15; 64:9, 10;74:16; 8,14, 18; 54:5; 58:18;
subjective 169:15; 71:2 SUN 60:22; 62:23; 67:22; 8,9,9,11,13,20; 71:8,9,
83:18; 94:13; 136:9; 62:3; 63:4, 15;65:12;
submission 7:19; 12:25; 82:11, 15;84:9; 88:6, 8; 10,11,15,18, 22;72:2, 3,
140:2; 182:12 69:l~7!118; 80:17,21;
72:13,24 ;73:12;78:21; 95:24; 99:3; 105:17; 4,8,13,14,14,16,16,17,
tslked44:ll;45:ll; 82:22; 88:1, 1;97:4,5;
80:9; 197:20 115:4; 127:11; 128:4; 17, 18,20; 73:3, 3,13,14,
61:25; 176:7, 16; 184:23; 98:11,23,24, 25; 102:4;
submit 13:2 129:13; 144:15; 158:16; 17,18,22, 24;74:2,4,10,
195:23; 190:18;209:3 104:18; 105:10; 110:22;
159:14; 164:23; 180:20; 11,21;75:4,10,21,24;
submitted 5:15; 23:2; talking 15:24;24:25; 116:19; 12025; 121:11;
183:21; 185:8,11, 13; 76:2,6,9,12,14, 17,18,
87:21,22 ;91:18; 92:7; 44:18; 67:20; 93:13; 126:1; 1308, 10; 136:21;
192:16;198:20;200:25 19;77:4,13, 22;78:5,6,8,
123:11; 165:6; 176:1 94:1O,11;104:6, 14; 142:4; 144:4; 149:19;
Surer 57:16 24;79:4,11,17, 22;80:13;
subsequent 75:24; 109:23;11014; 130:2; 152:11; 158:15; 159:1;
Surgeon 12:3
81:1,7,8,13,15,20,23,
90:18; 91:2; 92:4; 115:17; 143:7;147:3; 151:9; 161:1o, 11;182:14, 18;
25;82:5, 11,11,12,13,
164:18 surgeons-scope 152:16;154:11;155:6; 188:18,25; 190:18,20 15,17,20, 25;83:2,6,9,
subsequently 10:7;
174:19 177:17;187:21;210:23 192:18;194:8, 16;201::25; 10, 10,11,13, 25;85:6,9,
91:6; 97:11; 116:4 surgeries 19:19 taped 4:9 208:22 11,18,21,23,24 ;86:3,6,
surgery 19:14, 19;39:11; target 16:15, 16;180:11; Thank 5:10; 6:11, 15; 17, 24;87:2,3,12,14,17,
subset 32:5; 150:14;
43:22; 52:13 181:24 8:23; 11:19,20; 12:10, l~l; 17,19,20,21, 22,25;
195:13
surgery-in 19:18 targeted 181:25 13:20; 14:1. 17;23:8;25:2; 88:16,20,22, 23;89:2,6,
subspedalist 61:21 69:2L, .’./.- 3; 84:6;89:24;
surgically 19:17 taught 149:4 8,14,15,18,19, 22;90:5,
subspecialists 24:1; 90:1;91:22; 104:11;
61:11 SUrpriSe 128:5 teacher 11:13
11,12,16,19, 20;91:4,8,
106:6; 113:6; 118:6; 14,18,18,1992:18, 22;
subspeciatty 65:19 surprised 161:3 teaching 11:14 124:18; 133:14; 137:14, 93:4,10,12,14,16, 18;
substantial 92:17 surprising 50:21 team 23:25 15; 148:16, 17; 151:3; 94:4,18,20, 21,22; 95:1,
substantieta 55:22 surrogate 60:4 technkal 112:14; 153:25; 156:4; 175:20, :21; 6,7,8,9,13,16,19,21,
survival 111:15 124:13,20 192:6 24;%:3, 4,10,13,19,19,
~’-’ ~titution 17:5
survivors 152:17 technique 63:9; 123:18; thanka 56:17 21,22; 97:2,3,4,8,9,12,
s 112:6
\ Susan 4:11; 113:24 131:11 that 5:16, 19;6:4,8,22,, 12,13,15,18,19,20, 23;
ceded 10:22
techniques 63:12 24; 7:14,15,19,20, 24; 98:5,5,6,9,10,11,17, 17,
success 140:17 suspect 29:17 18, 19;99:1,4, 10,12,13,
8:2,4,7,14,18, 21; 9:3,5,
such 5:13, 23; 8:5, 9; suspicion 64:6 television 166:20
6,11, 16,25; 10:10,12, 18,19, 19; 100:6, 10,17,
60:3; 77:1; 115:3; 124:10; sustained 140:5; 143:20 tell 13:12; 18:A 59:25; 17, 23; 11:2,8,8,10,12, 19,20, 22; 101:3,5,8,10,
127:16;130:14; 177:12, symmetric 156:8 75:8; 81:10; 83:1,3,16 17;12:5,13,18,19,20, 19,23, 25; 102:1,3,5,7,9,
13;206:12 9925; 101:2; 108:19; 23;13:1,5,6,7,9,12; 10,11,15, 20; 103:4,5,6,
sympathetic 205:10, 20;
sudden 35:1o 116:6,8; 122:2; 147:9; 14:25;15:10,11, 25; 16:7, 10,13,14,16,18,20,24,
206:1 20923 ;210:19
suffered 177:14 10,10,13, 15;17:1,4,4,7, 25; 104:3,4,8,16,18,21,
syndrome 71:3 ten 54:18; 61:1; 126:23; 17,25, 25; 18:1,25; 19:3, 25; 105:1,3,4,6,20,22,
suffering 19:23 system 82:12, 13; 205:25 149:20 7,7, 21; 20:6,8,10,14,15, 23, 25; 106:10,12,14,16,
suffice 205:2 systemic 19:16; 20:2,3, 17,17,20,23, 25;21:1, 1, 18, 19,20; 107:1,3,13,
tend 15:19; 55:20160:1
sufficient 12:25;54:12; 6,7, 16; 21:4; 29:3; 36:3; tended 43:4, 17;82:21, 2,4,4,8,16,20,25, 25; 13,16,19, 21,24,25;
72:15;81:10; 106:4; 41:14,15 ;47:18;49:21; 25;94:7; 151:6 22:3,9, 12;23:2,2,5, 22; 108:3,8, 19;109:6,6,8,
175:25;198:22;202:13 55:18;99:15; 182:5,5; 24:11,18,23, 24; 25:6,18, 11,15,18,21, 23; 110:23;
184:24;185:1; 208:6 Tennessee 200:1
sufficiently 98:5 24;26:11,19, 24; 27:2,5, 111:6,7,13,18, 22; 112:2,
systems 190:19 term 42:5,9, 11,12, 13; 6,7, 17;28:2,5,21,24, 24; 3, 11;113:8,11,14,15,
suggest 60:13;63:2; 43:20; 44:2; 179:10
95:16, 21;99:1; 112:3; 29:6,7, 21; 30:6,8, 19; 20, 23; 114:5,7,8,12,12,
terminated 164:14,18, 31:1,5,5,12, 25;32:7, [3, 14, 16,21; 115:1,2,8,9,
140:13;160:7; 161:9;
164:5; 193:12
T 21; 165:12 12;33:2,3,5,9, 16;34:7; 18,18,20,22,22, 25;
suggested 82:17; 133:4; terms 208; 25:3,229:5, 35:12,12,20, 21;36:2,6, 116:1,8,12,13, 15,16;
160:11;165:13;171:19; T-cell 9:9 15; 30:21; 37:9; 39:21; 14, 15,23,24, 25; 37:1;!, 117:4,5,10,12,20,22,
193:10,20 T*ells 11:1 40:22; 41:14,17, 22; 19,22;38:6, 18;39:2,7, 23, 24; 118:8,13,16,18,
42:17; 43:24; 44:5; 46:6, 18, 19;404,15,16,17, 22; 119:2,5,6,7,9,13,13,
suggesting 135:2; 146:6 table 30:2; 35:16; 37:1;
22; 47:15, 23; 48:8; 49:1, 24;41:4, 20; 42:3,6,10, 18,19,20,21, 25; 120:4,
suggestion 72:4; %:4; 597; 134:3; 136:18
23; 51:14; 52:1; 53:1,20, 11,13,14, 22;43:3,8,10, 5,17,19,22, 24; 121:6,
165:15 tables 107:5,6; 111:5 24; 54:13; 56:15,24,24, 14,16,17, 25;44:14,16, 12,20, 21; 122:4,10,12,
suggestions 196:9 take 14:1;23:13;35”12, 25; 59:24; 60:5, 14;66:18, 17, 20;45:1,8,9,2046:6, 12,16,18, 21,24; 123:5,
suggestive 185:13 20; 53:24; 56:20;69:24; 19,23; 68:1; 91:16; 92:22; 8, 17;47:3,7, 10;48:16, 6,9,11,14,14,17,17,18,
$--’ests 31:5; 95:19
89:24; %:3; 10Q5, 10; %:10, 11, 12;98:13,20; 18;49:2,2,8, 19;50:13, 22,24, 25; 124:2,4,8,9,
107:3,5; 111:4;117:20; 99:20; 109:22;111:14; 18,19,20,21,23, 25; 10,15,19, 23; 125:4,6,8,
f 17:5 121:4; 122:19;123:4; 138:13; 146:21,25; 152:4; 51:1,4,6,7,15,16,19, 19, 15,25; 126:10,15,18, 18;
s merize 189:8 127:9; 139:3; 146:9; 155:10, 14;157:9;161:6; 22; 53:7,8,9,11,16,21, 127:1,13,18,20,20,23,
summery 24:3, 4; 70:19; 149:1; 165:7; 186:17; 162:21; 165:4;1697; 23; 54:7,14,18, 19;55:2, 24; 128:6,14,18,19, 25;
105:16;111:4; 134:3 199:16;210:17 176:6;183:11; 184:23; 7,12, 16;57:3,3, 12;58:9, 129:2,2,4,6,7,10,19, 21,
SUppOrt 8:21; 24:13; taken 39:23;68:13; 188:20;189:23; 190:21; 10, 12, 17,21, 23,25; 22,23, 24; 130:5,6,14,
68:1 1;89:13; %:8; 106:4; 73:21;81:8;91:18; %:18; 191:4;208:20 59:7,7,11,11, 11,20; I 15,17, 17,21,25; 131:1,

stuff - that (30) Mill-U-S(Xipt@ Miller Rmxmtl.mzComnanv. Inc.
Optha.lmic Drugs Subcommittee of the
Dermatolo$zic and OPthalmic Drug A&80ry Crete July 22, 1998

7, 11-12,13,14, 14,15, 3,6,8,
16;198:7,11,15,19,23, 25; 21:8,8,12,13, 53:4,
s,10,10,15,1s,19, 3,3,3,7, s, s, 10,15,15,
21,25; 132:1,2; 133:5,5, 19,19;
199:1,5,6,9,9,11, [4, 15;22:1,2,4,4,7,7,9, 22,
23;64:4,7,13,17,18, 16,19,21,23, 25; 108:1,
5,8,9,9,18,19,21,23, 12,14,
19;2(X12,6,14, [0, 11,14,16,17,18,19, :S,
18;65:3,5,6,6,7,9, 2,5,6,7,9,10,13,17,17,
23; 134:4,10, 13,17,21, 23,25,
25;201:2,3,3,5,6, [9,20,21, 21,22,24, 24; 10,11,12,20,21,21,25, 18, 18, 1S, 19,22,23,25,
24; 135:1,2,4,4; 136:4,9, 10202:23;203:1,5,6,7, ?3:1,1,2,3,4,4,6,7, 12, 25;66:1,5,5,
11,13,15, 25;109:1,2,3,5,13,14,
9,14,17,18,22,24, 25; 13,19,
23;204:1,2,4,8,[5, 23;24:2,7,8, 13, 13, 15,19,
23;67:3,3,4,7,9, 22,25; 110:2,2,3,6,7,9,
137:1,6,7; 138:16,16,19, 10,13,14,
15;205:2,2,5,[3, 15, 16,16,23,23, 25; 12,
20;68:2,2,2,3,4,5,7, 10,11,11, 11,13,14,15,
21,24; 139:4,8,10,11, 7,7,10,13,14,15,16,17, 15:3,6,9, 10, 12, 16, 18, 3,10,11,14,1’7,18,21, 15,17,17, 1S,20,22, 24;
14, 22; 140:2,3,7,11, 12, 18,21,24
;206:1,4,7,8, ZO,21,21,22,23, 24; 22;
69:3,4,4,5,6,10,13, 111:1,5, s,9,11,13,14,
13,16, 17, 17,21; 141:6, 13,15,16,17,18,24; 26:8,11, 15, 16, 18,23, [4,
14,16,17,19, 19; 15,15,15, 1S,22, 23;
11,13,14, 16; 142:8,11, 207:5,9,
18;208:8,10,12, ~4;27:l,2,5,5,8, 10, 12, 70:2,3,4,5,5,7,
12,12, 112:2,3,6,9,10,10,13,
20, 24,25; 143:4,4,6,11, 15,18,
19;209:1,6,7,9,16,17,17,18,19,22,22, 16,19,20,20,21,22,
24; 14,16,17,17,19, 20,21;
17,17,21, 25; 144:2,3,3, 11,19,
24;2109,13,14, 25;28:3,7, ~, 11,13, 14, 71:1,8,8,9,9,10,12,13, 113:1,5,7,7, 12,14,16,
5,7,11,13,15,15,16,19, 17,23,25 17,19,21, 21)23, 25; 15,20,21,22,
25;72:2,3, 17,19,22, 22,25; 114:1,
20, 21; 145:2,3,18,20, that’s
10:16;11:11;13:8; 29:5,9, 10, 10, 11, 12, 12, i,S,
12,12,12,17, 1S,23, 2,9,12,13,16, 1S,19, 19,
21,22,25, 25; 146:1,3,5, 14:21;
16:7;18:21;59:14; 13,16,18,20,21,23,23, 23;73:1,2,6,1.0,
11,11, 20,24, 25; 115:5,S, 17,
5,10,18, 20; 147:2,4,7, 63:4,
6;65:14;66:25; z4,24;30:2,2,3,4,4,5,6, [3,
15,15,16,17,20,20, 21,23,24, 25; 116:3,3,
10,11,12,16,19,23,23, 75:11,13,
22;76:23,25; ?,7,8,9,10,12,13,16, 22,24,
25;74:1,2,2,5,6, 10,17,18, 1S,20,21, 25;
25; 148:6,7, 10;149:8,11, 78:5;
84:2;
86:2,11,14, 16,17,17,18,18,20, 23; 10,11,14,14,
15,17,20, 117:2,2,4,5,6,6,7,11,
17,24; 150:4,5,8,9,9,10, 18;91:15;92:12;
93:19 )1:1,2,3,5,6,7,8,15,17, ?3;
75:2,5,6,8,9,10,11, 12,14,15,17, 17,17, 18,
13, 15; 151:4,9,18,21, 94:23;
99:17;100:4; ~4;32:l, l,3,8,8, 11, 12, 12,14,15,22,23,
25; 19,23; 11S:S,9, 13,14,
21; 152:5,8, 10,13,14, 102:22;
103:19;107:8; 13,13,14,15,16,16,17, 76:4,6,10,11,12,12,14, 15,21,21,23, 24; 119:1,
15, 15,25; 153:2,2,4,7, 114:16;
116:17,23; U, 22,23,24, 25; 33:2,4, 15,16,17,19,22,
25; 2,2,6,9,9,10,12,14,16,
17,21,22; 154:1,2,5,10, 118:17;
119:23;120:13, ), 10,11,12,15,17,17, 77:3,4,4,6,9,10,11,12, 17,18,21,22, 25; 120:1,
21, 23; 155:3,10,19,21, 24;123:2,
7;126:25; 18,19,22,22,23, 25; 13,17,19,20,20,22,24, [, 5,6, S,S, 12,13,16,18,
24; 1~6:8,W),20, 21; 127:16;
128:17;130:14, !4:1, 2,3,6,7,12,13,13, Z5,
25:7’+1,2,2,3,5,7,8, 19,20,23, 25; 121:4,6,6,
157:i>, AZ,24; 158:3,4,5, 24;134:14;
138:1;13925; 14,16,18, 20;35:1,8,9, 3,9,9,20,21,:21,22,
23; 7,8,10,11,17,20,20,21,
9,15,16,22,23, 24; 143:8,
23;148:10;154:13;11,12,16, 1S,19,21,23, 79:1,8,12,13,16,18,
18; 24;122:2,4, PO,11,12,
1591,6,22,23, 24; 160:8, 158:12;
161:19;162:25; 24;36:3,6,9, 10, 12, 17, 30:2,4,6,8,9,10,11,17, 14,15,16,16,16, 1S,20,
11, 17,20,21,22, 24; 173:23;
175:13;177:15; 19,20, 22; 37:1,3,5,7,7, 17,1
S,21,21,25;S1:3,4, 21;123:3,5,6,6,6,9,11,
161:2,3,5,8,8,9,10,12, 180:19;
182:9;183:19; 7,9,9,13,14,15,20,21, $,5,6,7,
S,9,9,11,11,14, 12,13,14,14,17, 1S,18,
12,12,13,17, 21; 162:6, 184:20;
187:2,5,21; 22,23, 24;3S:1,4,5,6,7, 16,19,20,21,22,24,
24; 23,24; 124:2,3,3,3,9,10,
8,10,15,17,19, 20; 188:1;
190:13;197:1; 3,9,11,12,13,16,16,17, 32:1,3,3,5,
1;!,13,13,
14, 21,21, 23; 125:8,9, 11,
163:4,7,15,16,17,18, 198:9;
200:17,24;201:14;ZO,22, 23; 39:1,1,3,5,5, 24;83:12,
14,:L6,
18,20, 15,16,18, 1S,1S,20,21,
20, 25; 164:1,5,9,9, 20; 206:5;
208:17;209:1,23 7,11,13,14,14,15,16, 20;84:2,3,7,
1.0,11,12,23,25; 126:2,2,4,5,6,7,
165:2,6,11,15,16,18, that-and 140:2; 142:13; 16,18, 1S,21,23,24, 24; 14,14,17,19,22,25,
25; $8,16,17,18,20,23, 25;
23; 166:8,8,11,11,15, 193:24 iO:3,3,4,6,7,8,8,9,10, 35:2,4,5,5,7,9,17,24, 127:1,3,12,15,17,22,
16;167:7,8,8,10,21, 22; that-if 157:21 15,17,18,20,21,22,23, 25,
25;86:1,2,4,7,7,S, 23,24; 12S:4,10,19,20,
168:2,2,6,8,12,14,15, that-it’s 127:11 24;41:1,5,5,7, S,9,12, 11,15,
1s,19,20,20,21,22;129:1,3,5,8,9,15,15,
16,23; 169:2,2,5,6,10, that-Regiman 161:2
17,22,24, 25;42:1,1,7,9, 22,22,23,23,
25;S7:2,2, 17,17, 1S,20, 25; 130:1,
10,14,16, 18,18,20,21, 11,12,14,16, 1S,19,22, 3,7,9,10,12,15,
1s,21, 5,7,9,9,10,13,15,15,
22,23,23, 25; 170:4,7, that-the 87:16 22,23, 24;43:4,18,20, 22,
25;88:2,2,3,5,16,18, 16,16,17,17, 1S,18,20,
12,17,21,23,24, 25; that-you 67:13 21,24, 25;44:6,6,9,17, 20,25,
25;S9:2,5,9,11, 21,22,23,25; 131:5,6, S,
171:3,4,6,6,7,8,12,15, the4:3,4,6,8,9, 11, 17; 1945:7,9,10,11,14,14, 14,
21;!M3,3,9, 10,11, 9,13,21, 25; 132:3,4.12,
17, Iq 19,19,21,21, 23; 5:9,11,11,13,13,15,15, 17,21,23 ;46:2,3, S, 11, 12,14,16,20,
24;91:2,2, 13,15,17,19,21,25;
172:2,7,10,11,13,15, 16,16,17,19,19,21,22, 13;47:1,2,2,3,5,6,8,11, 3,5,7,10,11,17,19,19, 133:3,4,9,12,12,17, 1s,
16, 17; 173:17,19, 25; 22,24 ;6:2,4,4,8, 12,13, 11,12,14,15,17,20,22, 19;
92:2,2,3,6,7,7,8,11, 19,20,20,21,23,23, 23;
174:7,9,13,16,17,20, 18,18, 24;7:3,4,5,6,8, 24;48:2,2,4,5,20,21,22, 15,17,19,21,23,24; 134:3,5,10,10,11,12,
20,22, 24; 175:1,2,5,8, 14,15,16,18,19,19,20, 22,24,25, 25;49:6,6,11, 93:2,7,8,11,
:L3,
14,14, 12,20, 22; 135:2,3,4, 6;
11,13, 14,16,17,17, 24; 22,23,24,25, 25;8:1,7,7, 13,14,17,20,22,23,24, 18,20, 11, 136:3,4,7,14,14,15, 1S,
21;94::2,2,8,
176:7,8,15,17,20,21, 8,10,11,13,14,16,21, 24,25; 50:1,5,5,6,10,12, 14,15,19,22,23,25,25; 19,24, 24; 137:2,6,6,11,
23, 23; 177:2,6,6,10,14, 22,23, 25;9:5,6,6,10,11, 15,15,16,18,21,23,23, 95:1,2,14,17,17,18,20, 13,16,17,19,20,21,23,
18,25; 178:4,8,12,23, 15,16,18,19,19,20,22, 25;51:3,4,4,7,8,8,11, 21,25;
%:2,3,5,10,11,24; 13S:7,7, S,9,10,10,
25, 25; 179:12, 15,22,24, 25; 101,3,4,4,5,7,8,9, 12,12,14,16,21, 23,24; 14,15,15,16,17,22; 12,13, 13,14,15, 1S,18,
24; 1804,5,7,24, 25; 10,11,12,15,17,20,21, 52:3,4,6, S, 12,13,16, 1S, 97:6,8,9,12,’12,13,13, 19,20,22,22,23,24, 25;
181:2,3,5,8,9,12,23, 24, 22, 24; 11:4,5,6,10,12, 19,20, 24; 53:4,4,5,6,8, 15,16,1S,
18,19,20,23, 139:6,7,21,22,23,23,
25; 182:2,6,8,11,16,22, 14,14,16,22,24, 25; 17,20,21, 25;54:4,7,7,9, 25;
9S:2,2,7,’10,11,14, 25; 140:3,7,11,12,17,
24; 183:1,2,5,8,10,10, 12:6,8,13,14,16,19,19, 10,11,12,14,14,14,15, 14,18,20,22,25;99:11, 1S,19,21; 141:2,10, 12,
12,23, 25; 184:8,12,20, 20,23,24, 25; 13:1,2,2,3, 17,17,22,22,23, 25; 11,15,1s,20; s,s, 13, 24; 142:12,12,16, 1S,
100:5,
24; 185:7,11, 13,22; 3,5,6,6,8,9,10,14,15, 55:2,3,8,9,10,13,14, 1S, 11,12,14,16,17,17, 1S, 21, 22; 143:4,9,11,13,
186:1,3,4,4,10,11,13, 17,21,22, 25; 14:1,1,2,2, 19,21,22,23, 24; 56:1,1, 20, S,16,24, 14,14,15,16,22,24, 25;
23;101:2,
24; 187:6, 12,14,14,15, 3,4,4,5,6,8,10,12,16, 4,5,6,10,10,15,18,19, 25;102:1,4,10,10,12, 144:1,3,7,13,14,15,18,
18,20,22, 24; 188:17, 18; 19,20, 24; 15:2,4,6,8,9, 23,23,24, 25;57:4,5, S,9, 14,16,17,21,22, 24; 20, 22; 145:1,1,1,3,7,9,
189:2,3,8,8,9,16, 17,21, 9,11,11,15,17,19,22, 10,11,17, 22;58:4,6,9, 103:1,6,
S,9,13,15,16, 11,13, 13, 15,1S, 19,20,
22, 24; 190:9, 14,17,24, 23,24,24,25, 25; 16:2,3, 10,11,13,14,15,21,23, 17,20,22,23,24;104:4, 22, 23; 146:1,2,3,6, S,S,
25; 191:1,5,6,16,18,21, 4,6,6,6,7,10,11,17,17, 23, 25;59:1,2,5,5,6,7,8, 4,6,9,13,15,18,25; 12,15,19,21,23, 24;
24; 192:1,2,9,9,11, 12, 22,23, 25; 17:1,3,5,6,15, 8,12,14,14,17,17, 1S, 105:5,5,7,
10, 12,1S,18, 147:3,6,9,9,10,11,11,
16;193:2,3,6,6,7,8,12, 17,21,23,24,25, 25; 1S,21, 23;60:2,12,13, 20,20,21,21,23,24,24; 14,15,17, 17,20,21, 24;
13, 16, 18,20, 23; 194:1, 18:3,3,6, 10,12,20, 23; 16, 19,20; 61:8,9, 11, 12, 106:1,3,3,4,4,7,7,8,11, 148:3,4,5,7,7, 15, 23;
4,4,10, 13; 1%:7,8,9, 12, 19:3,3,3,6,13,16,17, 19, 17, 19,21;62:1,3,7, 14, 11,11,14,15,16,16,19, 149:4,6,13, 13,15,16,
18,20,21,23, 24; 197:2, 25; 20:2,2,3,5,8,9,16, 15,16, 16,19,19,21, 22; 19,20,22,25,25;107:2, 24, 25; 150:1,2,3,6,8,8,
Miller Reporting Company, Inc. Min-u-script@ {31) that’s - the
Opthalmic Drugs Subcommittee of the
July 22, 1998 Dermatologic and Opthaknic Drug Advisory Crete

10, 14, 16, 1$19, 19, 20, 193:1,7,9,10, 11,23,25; 57:11;58:8; 59:13;66:16; 90:15;91:1,6,24; 92:8, 65:15, 22;66:2;67:2,15,
24, 25; 151:2,4,5,9,10, 194:2,7,9, 14,18,23,24, 75:2, 2; 76:5; 78:15, 17; 11,13,17; 93:18; 94:1,4, 16, 17;68:15, 16;69:9, 15,
11 12, 14, i7,2c,21,23, 25; 195:5,7,8,9,10,11, 81:20; 82:3; 95:11;%:21; 16;95:7, 8,& 97:2, 15; 18;71:21;72:25; 76:21;
~e ;2:3, 5,6,7,8, 12.12, 16,20; 1%:1,4,8,9, 11, 101:4; 105:9; 108:3; 98:5,12, 17;99:7; 100:19, 78:6, 11;79:2,4,5,22,23,
.6,18,18,23, 25; 17,18,19,20,20,21,22, 109:11; 114:4, 13; 115:19; 25; 101:6,19,21,21,22, 24;80:7;82:4; 84:10;85:3,
1>3:1,2,5,6,8,8,9,9, 10, 24; 197:1,7,9, 10,11, 11, 116:2,23; 118:10, 12; 22; 102:3, 5,9; 103:12, 14, 15, 15;87:7;89:3; 95:25;
10, 10,10,11,15,15, 16, 14,16, 17,19,19,19,20, 119:21; 121:11, 14; 125:2, 19; 104:2~ 105:23; 106:3, %:2; 100:6; 101:18;
17, 17,20,22 ;154:1, 1,7, 22; 198:7,8,,9,9,17, 25; 9; 133:15,22; 134:25; 24; 107:6,13, 23; 108:8; 102:6, 10; 103:2;104:2,5;
16,16,20,23, 24; 155:9, 199:3,6,11,15, 16,18, 143:18, 19; 147:19 109:5, 17; 11010111:6, 106:23; 107:10; 108:9,20;
13,16,20,21.21,22,23, 19,24;200:1, 1,8,11,13, 148:15,25; 150:14, 16; 9,10; 112:1;114:14,14, 109:20,21; 110:5,9, 19,
23; 156:5,7,8,8, 10, ;2, 24; 201:2,4,8,9,14,22, 153:10; 157:22; 158:9; 16; 115:7,9,10,12,13, 24; 113:15; 114:8;117:13;
13, 14,15, 19, 19,20,21; 23;202:13,17,24,24,24, 163:20; 170:10 171:22; 15;116:9,11,15,20; 121:5; 123:9;12623;
157:1,3,4,5,10,10,20, 25, 25; 203:1,9,15,16, 178:6; 187:12; 190:10; ll&8, 25; 1197, 14,19, 127:17; 132:11,13,18,19,
21,25; 158:1,3,7,14,21, 17,22, 24; 204:3,4,5,8,9, 203:1, 20; 204:20, 24; 24; 121:8,16, 16; 122:8; 22; 133:9; 134:2,20;
23,25, 25; 159:3,4,5,10, 11,12, 12,12,15,20,21, 205:2;207:2,4 123:3; 124:19126:4, 10, 135:4; 137:4, 18; 138:23;
12, 12,19,22, 23; 160:3, 21,22,23,25, 25; 205:3, then-new %:6 15; 127:19,25; 128:5,14, 140:4, 17, 18; 141:3,7, 17;
5,5,10,11,12,12,13,13, 4,6,7,8,9,12,12,13,13, 18, 20; 129:5,8,8,9,16, 142:12,18,18,22, 25;
theoretically 87:7
15,16,16,18,19,20,24,
14,15, 16,21,22,24,25,
25, 25; 206:1,2,4,5,8,9, therapeutic 8:6, 19; 15:6, 18, 23; 130:6; 133:2,4,6, 143:12, 16; 145:14, 15;
25; 161:1,1,1,3,8, 13,14, R 20:9,12, 24; 170:18; 8, 14; 134:13, 15; 136:4, 146:14,20; 150:1,11,21,
15, 19,22, 24; 162:2,5,8, 12,13, 21;207:3,6,8, 10, 19;137:1; 139:24; 140:2,
189:20;190:7 22; 151:1,5,6,9; 152:5,
13,23,24, 25; 208:1,9,9, 16; 141:4;142:19,20, ,24; 12,19,20, 22; 153:5, 18;
10, 11,14, 16,16, 19,21, therapeutics 167:12,22
24, 25; 163:1,3, 14,15, 9,10,11,12,13,14,16, 146:16; 147:18; 150:7;
16,19,24,24, 24; 209:1, therapies 7:7,10, 17;8:4, 151:13; 154:19;1566,16,
155:7; 157:6;161:5;
21;164:2, 13, 15, 15, 19, 2,5,6,9,10,10,12,12, 163:22,25; 164:2,3, 17;
11,12, 13,17; 11:10; 15:4; 19,20, 25; 157:2,23, 25;
19,20, 24,24; 165:1,4,5, 12,13,14, 14,15,16, 18, 19:12;28:2; 35:1; 36:7, 16; 165:3,23; 166:18,19,23,
6,6,8,9,11,14,14,15, 158:4,8, 14; 15Q”l,7,1.0, 24,24; 167:10; 170:14;
19,19,20,20,22, 24; 57:4;38:1, 19;45:9; 47:4; 23; 160:18: I62:1o, 18,,19, 171:12;176:6; 177:13;
15, 16, 19,21,21,22,2- 210:8,8,9,11,13,47,25 i8:24; 56:12;61:8; 70:7;
166:3,6,8,10,12,12,14, I the-1 113:16153:2 23;163:8, 19;164:1,4,12 180:15;181:12; 182:15;
3913,14, 17; 105:5,8;
16,22, 25; 167:1,2,3,9, 167:15,16, 22; 168:10; 193:11; 1%:16; 198:fO;
the-in 97:11 140:5; 141:13; 142:16,24; 169:15; 170:4, 13; 172:9,
11, 19,20; 168:5,5,7,8,9, 18&~ 187:2,3; 190:2 199:18;201:19; 205:3;
9,11,12,13,13,16,19, the-some 188:2o 10, 18;173:24; 174:24; 206:6;209:25
therapy 8:l; 13:17, 17; 176:22;179:6; 180:8,25;
,23,24, 24; 169:2,2,4,10, the-there’s 205:13 thes~since 132:17
12,12,17,18,20,21, 24; 16:16; 18:1,2,13,14,16, 181:24; 182:6; 186:6,8;
their 5:23;6:23; 10:6,6,8; 16; 19:8;21:17; 29:3; 34:9; 1891, 10; 191:10,25; they 6:8, 10; 10:8; 13:1;
170:7,12,19,20,21,21, 15:4,21, 21; 18:5;30:24; 15:20; 16:4,6, 14, 16;
~—>, 23, 23, 25; 171:4, 5912,16, 23; 60:2,12,15, 192:9; 194:19;195:5;
32:8; 41:19, 19; 50:24; 15, 23; 62:23; 68:10, 16; 19:14, 15;20:8,10, 19;
,8,8,10,10,13, 14, 51:5; 56:16; 57:1,1 ;61:18,
1%:7, 13; 197:16; 198:2,
703; 8913; 90:693:1; 26:1o; 28:20; 29:15;
1-,15,16,20,23, 23; 20; 63:12; 89:3; 92:16; 17, 19;200:23, 25; 201:16,
99:7, 7; 104:14, 14; 24;203:2, 10,11,12,19, 31:12; 32:8; 34:10; 36:5;
172:2,4,7,8,11,15,16, 104:5; 108:22; 117:9; 44:2,12, 14;48:16; 56:22,
16,17,19,21,22,24,24, 105:25; 1097,9, 17; 23;204:11, 14;205:5;
121:15; 123:10; 133:10; 110:9; 113:18; 138:8; 23, 23; 61:2,3,19, 19;
25; 173:10,12,14,17,18, .40:4; 141:8; 148:17; 208:22;209:2;210:22
139:13,15, 17; 14015; 62:6; 63:12, 20;64:1, 5;
20, 22; 174:1,3,4,6,8,9, 151:1,8, 15; 152:3; 165:4; there’d 190:24 65:19, 20; 66:22; 67:6, 9;
141:8,21, 25; 142:20;
10, 12,13,13, 14,17, 18, 167:13; 179:16; 180:13; There’s 11:6; 20:14; @15,19; 71:19; 72:5,9;
1463, 17; 1%:21; 18(Y2,
20,22, 23; 175:1,2,2,3,3, 182:7,9, 17; 183:14; 56:21; 57:19; 59:8;65:15; 73:17; 75:14,15; 76:5)6,
4, 14; 181:2,4; 183:19;
4,5, 10,11,12,13,15,15, 186:8, 13; 192:19; 197:12; 67:13, 13;69:20, 25;79:4; 17, 187915 ;80:14, 19;
186:6,13,15, 24; 187:7,
16,18,18,18,22,23,23, 200:15;201:21 82:2, 4; 83:22; 89:12; 81:4,6,10, 23; 83:22;
24,25; 176:1,9,16, 17, 13; 1%:3; 203:3; 208:6,
them 11:22; 35:2; 46:3, 23, 24; 210:18 95:15; 97:17; 102:19; 86:20 8&6, 7,9; 897, &
20,21, 23,24; 177:1,5,5, 24; 48:9, 18; 54:6; 56:8, 113:1;115:4; 117:8; 90:7,17, 20; 93:6; 100:23;
6,7,8,10,14,15,16,18, therapy-had 144:9 119:12; 129:7,24; 130::24;
20, 24;64:5;65:16; 68:13, 106:8; 107:15; 108:21;
18,19,19, 25; 178:4,5,5, there 5:25; 613; 818 131:3; 135:3; 152:7; 110:25; 112:3; 113:16, 24;
16;72:7, 10;81:7; 82:16;
6,8,11,11,12,15,16,20, 12:5,17, 24; 13:4, 12; 155:8; 159:1; 163:18; 114:9; 116:7; 118:5, 10;
84:24; 88:5,1090:23, 24;
21,22,22,23, 24; 179:1, 17:5, 18; 19:2,18 2012; 180:25; 193:19; 195:8; 120:25; 122:5; 123:11;
91:3, 5;95:1,4,5; %:16, 22:3; 29:2, 11;30:14, 25;
2,2,5,11,11,12,18,22, 17; 100:18;102:23;104:3; 1%:25; 197:6; 198:17; 126:6,21; 127:15, 20;
23,24,25, 25; 180:2,2,3, 106:10;107:6; 112:9; 31:25;32635:1; 37:21; 199:3;201:18; 206:11; 128:20,21; 129:13, 14;
7, 10, 11, 18,19,22, 24; 38:22; 40:16, 19;41:18, 208:6 130:21; 132:23, 24; 135:3;
114:4,23, 24; 118:12;
181:3,8,15,16,24,25, 20; 43:10,14, 25; 44:19, there-are 103:14 137:10; 138:4; 141:20, 21;
121:11,12,12 ;128:3,6;
25; 182:1,4,5,6, 11,12, 20, 23; 45:4, 6; 47:13,18, 144:21; 145:15,20,22,23;
130:8;131:20; 133:1,7, thereafter 48:19
14,17,23, 23; 183:1,1,3, 19, 21; 50:18 53:11; 54:8, 150:14,22; 151:7,10,11,
18 138:5; 140:24; 142:20; Therefore 8:2; 13:6;
7,8, 10,14,14,17,23, 24; 11;55:5,7, 18;57:19; 21; 152:21;153:6; 155:12;
145:21;151:24; 154:21, 17:2, 13; 124:25; 177:6;
184:6,7,8,9,11,16,16, 24; 158:8; 163:17;164:13; 58:8;59:9, 11;60:1, 23; 157:4,7,8,9, 21; 158:2,6;
16,17,19,21,24,25, 25; 63:9;65:18; 66:4,13,14, 204:12; 208:18; 209:15
165:8; 181:14;183:13; 159:25; 161:24;163:2,4;
185:7,8,9,16,19, 23; 21;68:20; 69:7, 24;70:6; these 7:10,10, 24; 8:9, 164:14, 16; 165:14;
190:15;191:3; 194:16
186:3,9,10, 13,14, 19; 71:5,6,11,18, 20;72:13, 11,13, 17; 10:9; 17:7; 167:11;173:7; 177:25;
200:14, 15;207:12;
187:2,4,5,14, 15,15,16, 14,18, 24;73:4,12,13, 18:21; 19:22; 2023; 182:8;186:8; 187:12;
209:10 21:17; 22:7; 26:9; 29:20,
17, 18,21, 22,25; 188:5, 16,21;74:4,6,7,7,8,9,9, 194:15; 198:23; 199:23;
them-1’m 154:20 9,15,19, 21;75:5,7, 10, 21;32:3, 11;33:9, 13, 20;
8, 13,14, 15,17, 17,19, 205:1,9,15, 17;210:9, 18
‘=A x 22,22,23,23,24, themselves 4:7; 5:23; 13,14, 24;76:2,9; 77:14, 34:21, 24; 35:13, 23; 36:4,
}:1,1,2,4,4,6,7,8, 11:22; 100:7 17, 17;78:19;79:5,6,12, 7, 18;39:17; 40:14; 41:12, they’ll 200:2
9, i ,,12,20, 24; 190:2,3, then 8:16; 10:20;24:4; 17, 17;80:10,20,24 ;81:1, 18;42:3, 15,20, 21;43:1, they’re 20:13;56:22;
6,8,17,21,24 ;191:1,3,4, 27:14; 28:14, 23; 32:19; 13, 18;82:19; 83:6,15,23, 4, 24; 44:1,15, 18;45:7; 62:11;63:11; 64:12;
5,7,9,11,14,14,17,18, 33:25; 34:4; 35:10; 37:9; 25;84:1,4, 17;85:8, 10, 46:23; 47:12, 16;48:9; 107:14; 130:9;138:25;
18, 18,20,22,22, 23; 38:7; 39:10; 40:2; 41:1; 14, 14;86:14;87:12; 49:14; 50:12; 53:1, 2; 54:4; 139:4, 5; 161:6;210:15
192:1,2,4, 10,10, 12; 47:5:48:1849:2053:1.
.-, .,, 2: 88:13,21, 22;89:18; 61:1; 63:23;64:1,14; they’ve 57:9, 10;183:12;

the--I - they’ve (32) Min-u-seridm
OLXIMI.MicDrug8 Subcomdttee of the
July 22, 1998
D&matologic &d Opt-hdmic Drug Advisory Crete
13,20;188:9,
11; 189:22, ‘9:7 tissue 172:8
210:2.2 hink-1 140:10; 190:23
hink-the 179:21 25;191:15,
18; 192:2; hreehold 115:25; 116:2, tissues 17:8
thin 663,3
hink-while 95:14
193:18,
20;194:7,14,15, };118:21; 119:1,21 tissues-is 66:19
.—% thing il:ll; 17:25;44:17; 18,2Q 195:19,23,24; :hrough 14:23; 15:17; titers 140:23
73:24; 75:15; 76:19; hinking 70:I; 103:6; 196:14;197:22;198:1,11,
83:14; 137:8; 146:1;
[1:4;42:4; 49:8; 56:13; to 4:2, 3,6,7,8,9; 5:12,
60:9 21;199:12,13,14,15; $6:5;69:17; 70:19, 21; 13,22, 25;6:1,2,3,6,7,
156:20; 161:8; 165:22; bird 25:24; 49:6; 83:18; 200:5,6,12;
202:9,12,23; ?2:7,8; 80:24; 86:19;
168:5,20; 173:12; 174:10,
10,12,13, 24;7:2,10,16,
.02:22; 154:21; 163:23; 203:7,7,12,15,15,25; )7:11; 100:14; 102:21; 25;8:1,4,4, 10,12, 12,15,
20, 22; 190:17; 1%:18; !00:9 204:5,5,10,
14; 206:7,8, 103:1;104:6 107:X; 16,16,18,20, 23;9:3,4,9,
197:1;203:9; 205:22 bird-party 186:9; 10,11,17,17;207:25; 131:7;137:2; 139:16 10,15,16,17, 24; 10:4,6,
things 9:16; 23:11, 12; 187:18;200:13 8:3.8,12,13,20;209:9,14925; 153:7, 12; 156:15; 7,13,14,19,20,22, 23;
33:9; 42:14; 45:20; 46:23; birds 98:4 ;2io:i,21 179:17;182:4, 24; 184:15; 11:4,4,5,10,17,22, 22;
58:2;60:7, 21; 65:17; is--1194:1 Z01:19 12:6,8,11,11, 13; 13:1,3,
:his 4:3,3,8; 5:12,14, 19;
67:17; 82:12; 84:11;85:2; is-these 153:21 8,21; 14:1,1,3,3,16,16,
T:2,17;8:1, 22, 23; 10:17, rhroughmt 24:10; 27:8;
97:8; 100:14,15,16, 17; tomes 179:5 17,19,19,19, 22; 15:1, 1,
23;11:7,7,9; 12:11, 16, 59:18;%:9; 109:9;
103:8,9, 25; 116:13; 24;13:10,11, 16; 14:1,4, 6,7,8,16,17,19,19, 20;
122:18; 127:2; 135:2; rxough 172:4 142:12;151:1
16:4,9,10,14,15,22, 22;
136:8; 139:13; 140:11,21; j, 8, 16; 15:1,2, 16; 16:23; Dse 15:20; 19:16;31:7; throw 104:1 17:6,6,8,14,17, 21; 18:7,
17:5,21, 22; 18:3,5,8, 10; :2,8, 21; 36:22,23, 24; thrown 104:2; 205:25
147:3; 183:5; 187:25; 8,10,12,15,16,23, 25;
20:13,15; 21:10, 14; 22:1, :4;40:21; 44:24; 45:4,8, 19:1,6,8,14,16,17,23,
190:4; 198:7; 199:3; thrust 100:5
3,14; 23:3, 19; 24:1~ ; 46:17; 47:25; 49:8, 16;
210:13 thus 116:3; 18:2:9 24; 20:2,6,18, 20;21:9,
26:23;27:13,1628:4,8, :19)20, 25; 51:6,7,19, 16, 17;22:1,10,18, 23;
think 11:8; 19:2; 55:7, 12; 16 29:2; 30.1~ 31:1,4, I,23, 24; 52:3,8; 56:19; tied 88:16
58:22;60:15; 64:4, 16; 23:3,7,7,11,13,15, 16,
25;32:19; 35:22; 37:1, 4; :24;64:21; 65:11;67:5; time9:14,22, 24; 10:23; 17,20,21,21,22 ;24:4,
65:14;69:20, 23; 70:9; 38:21;40:16; 41:4; 42:15; :6;71:13;73:23;74:21, 11:2;13:3,6; 14:16; 18:24; 10,13, 21,21; 25:3,4,5,
74:18; 80:23; 81:22; f3:17, 20; 44:11; 45:16, ‘;80 10;82:6; 83:17; .:21, 25;261,4, 15,18 J,18.21,25; 26:1,4,&
89:21;93.7,21; 95:15; !3; 46:2, 13, 16, 22; 50:24; ):17; 90:12; 91:8; 93:17; 7:9;28:10, 13;30:3,7,
96:6; y7:17; 99:17; 1,13,18,22, 24; 27:2,
il:18; 52:4;53:3, 12, 17; L6, 18;%:7,8; 97: 10; 3,24; 31:1,2,:3,4,5,13, 2,12, 13;28:10, 13,21,
100:13,19, 25; 101:6; ;6:11;57:3;59:22;60:2, 3:1,3,4; 102:13, 15; f, 19, 19;32:6,8, 17; 3,24; 29:12,18, 23;30:3,
102:7,12,17,20,21, 24; !0;61:15; 62:13; 63:13, )3:8; 107:5, 5; 109:1O; 3:17;35:11, 2:2;36:3,6,
103:5; 106:1, 14; 107:12;
1,18,18,23,24 ;31:1,1,
,7, 20;65:8;66:4,15, 24; 13:23;115:12; 116:6,24; ), 12,22,24, 25; 37:5, ,11,13,14, 19,20; 32:6;
111:22:112:19;115:4; ;7:19,23;68:25;69:3, 17, 17:3,9, 19; 1184, 25; 1,12, 22;38:6, 10;39:11,
117:24;119:12:23, 23; 3:4,18;34:2,6, 24;
!3;70:2,3, 10;71:8, 14, 19:7,19, 22; 120:10; 3, 16;44:9;46:13;60:2,
120:16,19,22, 23; 121:23 5:11,11,17, 19,20; 36:2,
.. 16;73:12,23, 24;74:1, 10, 22:4,17,19,20, 25; ,10, 12;69:24; 72:12, 23; ,5,9,11,12,19,20,24,
=— 25; 122:23;123:17,24; 11;75:4, 12;76:19;77:20, 23:15,21; 127:2, 21,22; 3:11;75:1,10,11,16;
124:8, 19;125:5,6, 12; !4, 24;78:4; 80:8;82:14; 5;37:4,5,6,11,13,20,
28:1,6; 131:5; 133:6; 6:12, 14;77:4;78:2, 21; 2,22, 24; 38:3,10,11,
126:6, 18,22,25, 25; 34:9,21,25, 25;85:5,9, 34:15,22; 140:6; 141:14; ~:9,25;81:5, 1,6,24;
127:13,16;128:11,12; 6,18,20, 21;39:12, 18,
17,19, 23;86:3,6,12, 17; 44:19,23, 24; 145:3; 3:1,2,12, 13;!?1:6,8; 9;40:4,10,13,16,19,
129:24;130:5,14, 21; 37:6;89:17;90:11;97:24, 51:3, 23; 152:2, 19; 2:11;%.12, 15;9813,
135:7;140:7;141:3; 0;41:15, 17,21, 25;42:4,
24;98:14; 100:1,2,20, 25; 58:4; 160:8,17, 2~ 5, 20; 1o(Y2O;103:21; ;43:4,16, 17;44:3,17,
142:14;144:21; 145:3; 101:6,15,16,20, 20; 61:4, 11,20; 163:10; 0&5; l@k14, :17,25;
14616,20, 22; 14819,21 9, 22;45:1,7, 18;46:4,7,
103:23;104:7,18,21,24, 66:7; 169:14; 170:16; 10:3,18,22, 25; 111:8, 0,13, 24;47:7,12, 12,
152:5,25; 154:1;160:3; 25;105:8,9; 106:22,24; 71:2o; 176:8; 190:4,6, 1,15,20 ;112:7; 113:12,
161:19:162:18,19164:1 9,22, 24;48:4,4,13,13,
107:2;108:14,14, 17; 8, 19; 192:2; 195:16, 17; 7, 19; 114:2,7, 19; 7,17, 18;49:6, 15;50:5,
3,4, 9;165:22; 168:2,7, 109:1,2,4,13 ;11O:1,2, 98:11, 22; 199:2,23 15:16,22; 117:25; 118:9,
22, 23;169:6; 171:22; ‘,8, 12;51:22;52:7,12,
13;111:12,23; 112:7,15; 00:13; 201:3; 207:18 4,15; 120:5; 121:11; 6, 20; 53:16, 22; 54:12,
173:13, 21;174:9,13, 16; 114:16;117:4,5, 16; bough 99:1; 113:15; 22:11; 123:4, 5,7;
175:8, 13;176:4,10,12,119:5;12011, 18,23; 9; 55:1,1,4,19,20, 22;
41:5; 172:14;181:12; 25:15;128:11; 140:21; 16:8,18,19,23, 23;57:5,
15,17,20,22, 23;177:22;122:1;123:4, 21; 124:7, 82:5; 184:1~ 191:10 41:19, 22; 142:16;
178:25;179:11,22; 180:2 17;125:12, 15; 127:% ),8,8, 13, 14, 14, 17, 21,
bough-end 79:10 43:16; 145:5; :146:4; !2;59:1, 10, 10, 10, 14,
16; 181:11,13; 182:15,2? 133:16 134:a 13616 51:7; 152:18; :154:18;
24; 183:4,8,10,13,19, bought 40:12; 46:6; !2,23;60:2,4,7, 13, 13,
137:5, 12; 138:6; 139:1O, 56:14,18, 20; 159:22; .6,24, 25;61:4,7,8,14,
25; 184:1,14,16,17, 19; 11; 14022; 141:12;142:3 ,1:15;60:5,67:21; 69.1;
‘0:11;73:14;79:11; 85:8; 60:9, 12;161:”11;162:4; .7, 25;62:8,8, 12,12,14,
185:2,13, 17,21,22, 23; 9, 10; 143:14,21; 144:7,8 .63:13; 164:2;:L6523;
186:1,22; 187:14,20, 24; 6:16; 103:3,4, 21; 124:9 [6,20,21,22, 23;63:1, 3,
145:5,9, 17; 146:9,22; ,66:17; 167:11; 170:7; [0, 11, 14, 17,20; 64:12,
188:1,7,9, 17;189:2,8, 147:4,4; 148:19, 19; 43:7
,71:21; 183:18;185:7; [2, 13, 14,24 ;65:5, 12,
18, 21; 190:3,8,13,20, 149:2,6,10,12,15,16, houghts 204:7,19 ,95:23, 24; 197:16,20;
24; 191:3,9, 16; 192:8,9, [3, 14;66:16; 67:1, 2,5,8,
17,20,20, 23; 150:3,5, LhOUSalld54:18 199:18;201:17; 209:13 8, 23;68:3,7,14,18, 18,
11,22; 193:1,4,6,9,18, 11; 152:8;153:12, 14; threat 10:1
19;194:1,2,4,6,8,23; tirw+and 145:3 20;69:24, 24;70:1,2,2,3,
154:15; 155:16; 156:6,12 thrae9:l l;18:ll;23:ll; 6,6,8,10,13, 18,21 ;71:5,
195:4,8,13,19,20, 25; 158:13; 15915; 162:5,7, tirnsAhe 169:11
196:2,11, 25; 197:4; 28:19;33:24;44:13,23; time-dependent 5%1% 12,12,12,13,14, 22;
12, 14; 163:13,24; 164:9: 46:6; 50:11;53:1;74:7; 72:4,7,10,15,17,19, 19;
198:8,14, 15,17, 20; 166:9,9,11,15, 22; 167:? @.18; 147:19
199:2,5,9, 15;201:8,9, $ 78:15;81:21;93:13,16; 73:1,2,3,4,4,14,15,17,
8, 17; 169:21; 170:3,5; 98:4; 106:22; 109:17; timely 192:23 22;74:2,4, 11, 17, 22;
11, 19;202:17; 203:12, 1, 171:25; 173:3,10, 11; times 35:3;36:1944:13
16, 17;204:19; 205:1, 2,( 134:5,5, 5,6,7; 149:12, 75:7,8,12,22, 24;7611;
174:5,7,8,20175:4, 10; 21; 153:23; 161:1O,15; 7817; 100:15; 103:23; 77:3,7,8,13, 22;78:2,7,
9, 12,14, 24; 206:2,4,12 178:11; 179:6,8,14, 21; 121:14;13223; 141:18,
14, 21;207:8, 15;208:15. 163:16,19; 165:18; 19;79:12; 80:13,20, 25;
180:14,18, 22; 181:19; 197:20;199:20,20,21,2 25; 142:9; 152:13;160:3; 81:2,6,10,10,12,14, 15,
19,25;209:2,7,19,23, 182:2,7,17, 22; 183:11, 194:17
25; 210:1,6,14,25 24;207:11 23;82:8,9, 15, 16,21,21,
16;184:2,4,6,15, 18; tion...yo11ll 851:3 23,24, 25;83:5, 11, 16,
think-did 68:23 185:3,6,7,7, 19; 186:3, three-dimensional 79:
three-dimensionally tip 54:22 16, 20;84:9, 10, 10, 11,
think-for 169:4 14, 23,25; 187:2,4,6,11 [,

{%4> thin - tn
Miller Reporting Company, Inc. ‘ hin-u-scf’ium
Opthalmic Drugs Subcommittee of the
July 22, 1998 Dermatologic and Opthalmic Drug Advisory Crete

15,18, 22;85:7,7,8,17, 25; 166:2,4,4, 10,14,17, together 10:9; 16:11; 2;141:3,7; 151:18; 152:2, tried 10:22;73:22; 144:19
20, 23;87:3,3,13,14,19, 19,19,22, 25; 167:3,6,7, 38:3; 42:15; 43:1; 44:7; 11; 158:8,23; 159:3,23, triviai 130:24
*-’ 22;M:9, 9, 10, 13,13, 7,9,9,21,23,23, 24; 51:19; 65:8; 121:13 25; 160:1;161:24; 162:3; troubie 210:16
1,23; 89:1,3,5,7,7, 168:1,3,4,5,8,8,15,20, told 48:8; 65:20; 155:13 163:12; 170:13; 187:8, 12;
-, 15;90:6, 19;91:4,9, troubied 205:7,7
24, 25; 169:1,2,3,5,5,7, tolerated 21:6 205:9,17
17, 23;92:9, 25;93:1,4,8, 24; 170:2,2,6,20,20, 22; troubiing 103:I4
Tom 923 treated-right-it 169:13
16,16,18,20,21, 25; 171:5,9,13,14, 16;172:7, trUC!19:3;35:22; 53:5,8;
tomorrow 71:ll treating 8:14; 27:22;
94:1,7,13, 23;95:6,9, 12, 11,11, 19; 173:2,5,7,9, 65:14;76:25; 81:18;
tonight-is 181:19
42:1;44:12;61:20; 68:14;
15;96:6,7,8,12,15, 16, 10,13,14,17,23,25,25, 92:12;99:17; 140:21;
81:4
23, 24;97:6,14,15, 25; 25; 174:6,7,8,12,13,20, tonight-today- 167:8;209:10
98:1,7,15, 20;99:24; 21, 22; 175:1,3,5,14,15, hopefuliy 181:18 treatmant 6:21;8:22;
truly 59:20; 60:1
100:1,2,10, 17; 101:2,13, 17, 23; 176:1; 177:15,16, 10:4;14:6;21:8;26:4,23,
too 15:22;75:7;82:24, truth 122:2
16,23; 102:14,24; 103:7, 17,22; 178:11, 14; 179:13, 24;27:18, 19,20; 28:7,8,
24;91:4, 4; 92:8;97:25; try 60:4; 83:18; %:7;
9,15,18, 24,24; 104:4,5, 16;180:3,5,6,11,17,17, 147:17 9,18,22,24, 25; 29:19,
24, 25; 30:7,8, 17;31:4,6, 103:22; 146:22; 166:19;
21,23, 23; 105:1,4,9, 17; 17,18,19,21, 22; 181:1, took 10:23;40:18;61:13; 189:19, 22; 190:2; 198:24;
106:3,8,9, 10,10,11,15, 5,5,9,18,19, 21; 182:4, 7, 24;32:15, 18, 24; 33:14;
118:3 206:6, 23; 209:24
15,18,19,20,22,24,24, 12,13,18,21, 22; 183:3, 35:13; 38:14, 17;40:3;
top 17:23;19:3;50:15; 41:1,5,10; 45:13; 47:14; trying 9:15; 103:24;
24; 107:1,3,12, 15,19, 4,9,10,12, 13; 184:1,12, 84:14; 108:19;1096;
12,13,16, 18; 185:8,9, 50:13;54:17;55:13; 104:4; 124:6,13, 15;
22; 108:10,13, 14,14, 17, 197:10
15, 15, 18, 19,19,20, 22; 59:17;61:15, 16;65:7; 131:21; 141:15; 143:1;
19, 19,25; 109:15,21; top-the 84:14 148:21,24, 25; 149:23,25;
110:13,15,15, 16,16, 16, 186:4,5,5,6,10, 21; 67:20;68:3, 13;71:1;74:6;
187:1,1,3,5,11, 17; topic 159:16 76:5,7,11,18, 18;92:23; 152:5; 159:12; 164:20,23;
18,20,22,23,25 ;111:11, 168:1; 177:15; 180:21;
15,23, 25; 112:2,3,7,8, 188:4,4,9,9,11,13,14, topicai 43:13; 48:11,12, 94:3; 107:16;113:9, 19;
15; 189:6,7,15,18,19, 14;67:3 114:6;121:7; 133:3,6; 181:18; 194:6
10,17,22,22, 25; 113:1,
22, 25; 1901,2,8,13,14, Iotai 24:17,23; 25:7; 134:6,7; 135:3; 136:16; Tuesday 10:14,18,19,
2,5,8,18, 18;114:1,2,5,
14,14, 25; 191:2,8,13, 35:1; 38:9; 4016; 90:11; 138:1>;1V:21, 22; 20
13;115:12,24;116:12, 13,
14,25; 117:9,14,16,24, 14,14,15,16,19,21, 21; 108:4; 111:7; 160:24; 144:.,, A(J,22; 145:6,:20; Tuesday-a 10:20
25; 118:2,3,5,7,10,20, 192:3,10,12,13,14,15, 161:1; 172:2 146:10, 13;147:1,2,21; turn 23:7; 24:4; 27:le;
22, 25; 119:2,2,2,4,6,9, 22,23, 23; 193:2,3,4,5,5, tOtSiiy 10:16;176:9 148:4,8, 23; 151:8,22; 31:8;4O:1O;49:6; 53:4;
J3, 24; 120:3, 10;121:4,4, 6,7,9,13,18,19,23,25, 152:25; 158:2,3; 159:22; 137:16; 204:1; 206:20
toward 40:17; 45:6;
6,7,9,18,19,23,24,25, 25;194:6,7,7,8,10,11, 160:18; 161:2;162:7; tUrIVSd23:17;45:18;
47:13;48:25; 156:17;
25; 122:2,5,10,11,13, 13,18, 19,25, 25; 195:5, 163:15,21; 176:9,24; 46:10; 124:10
183:19
~p .25;123:4,5,7, 14; 15, 17; 1%:2, 4,10,10, 177:12, 13;180:1; 181:22;
.— toxic 10:5;67:8; 172:7,9, twice-a 167:24
;,7,8, 10, 13, 15,23; 13,15,20,23, 24; 197:1, 182:3,4,7,8,11,16, 1:6;
3, 21; 198:5,22,24,24, 11; 182:6;1%:24 184:9;185:25; 186:2; tWO6:13;9:6,10, 13;
~O;126:2, 14,20,21; 1012,17, 19,24; 11:1,21;
25;199:1,4,6,8,10,15, toxicities 15:23;20:2; 188:24; 189:1;195:10,11,
127:1,8,9,10,12, 18,25; 18:10;21:13,20; 23:11;
128:11,22; 129:6,18,21, 16,23,23, 24; 200:5,6,9, 160:5 16;203:20, 20; 208:1, 16,
10,11,14, 14,15,20, 25; kmicity 20:8;54:11; 25 24:1;25:10, 15,23; 27:14;
22; 130:5,9,17,20, 25; 28:20;29:16, 20; 30:20,
131:8,13,21,23,24,25; 201:7,7,13,14,20, 22; 170:1,3,4; 172:5 treatments 27:23;41:2q
202:3,5,8,8,12,13,15, 20;31:25; 32:3,7,13, 16;
132:10,12,12,20, 25; toxicology 71:7 56:14, 15;7815; 161:16;
18,19, 23; 203:5,6,6,13, 33:19;34:1, 12, 16,20;
133:10,15,16,16,16, 17, tOXh 172:14 162:11; 182:19; 183:23; 35:1,13,19, 23;36:18;
20, 24; 134:6,10, 16; 16, 23;204:3,3,5,10,10, 188:16; 193:12; 1%:1 1;
15,15, 22;205:4,9,10, track 115:6;158:25; 37:21; 38:22;43:8, 12;
135:1;136:5,7,8,10, 15; 198:22 202:16, 18;203:19, 21; 44:13, 20;49:3; 50:10;
137:2,5,6,11,12,16,17, 11,14,15,15,16,16,16, 205:15;207:25; 208:1
18,18,20,20, 22; 206:1, tract 66:! 52:3,8, 21; 58:1;65:20;
19, 19,22; 138:11,12,14, tremendous 75:3; 66:25;67:2;68:6;76:2;
17, 19;139:3,6,8, 25; 2,4,6,6,7,13,15,16,17, Traditional 15:18
167:17 78:6,10,16, 17;79:5;
140:2,8,13, 14, 16,25; 18,21, 23;207:2, 5, 18; traditionally 187:24
208:2,3,9,14, 23; 209:1, tremendous-and 81:21;82:1, 2,4,7, 23;
141:4,7,12,15,19,20, train 117:16 167:16 85:2,13, 24;93:13, 15;
23; 142:1,6,8,9, 14; 5,6,8,10,14,21,23,24,
trained 149:4 tremendously 79:23; 94:1O,15;98:3; 103:3;
143:1,2,3,13, 16,21,24; 24;2101, 2,8,15,19
training 11:13;63:14, 17; 167:25 105:21;107:13; 108:1,23,
144:12,14,16,16,19,19, tO-25 163:22
65:19; 149:6 trand 45:6; 47:13; 48:2, 24; 109:5;110:12; 111:8,
19; 145:7,13,17, 19,23; to-and %:23 9, 19,20; 115:4; 119:18;
transcribed 16:3 25;79:17; 80:20; 133:2,
146:1,8,8,18,19,22, 22; tO-1 68:8 121:8, 17;123:15; 125:9;
147:1,5,17,20, 23; 148:2, transiant 43:18; 48:10 23; 156:16;164:9
to-if 105:7 156:25;201:3
126:19;129:16; 132:19,
3,5,9,14,15,16,17,19, triai 23:13; 28:16;32: 19;
to-okay 210:6 22; 133:6;136:17; 137:11;
21,23,24,24, 25; 149:6, transition 60:11 36:22; 37:4;44:21;45:2; 140:21;143:17; 144:13,
7,9,17,20,23,24, 25; to-perhaps 180:17 transiete 107:5 5918; 61:7,14 ;63:5; 16,23, 24; 145:19; 150:20;
150:3,6,15,17,22, 24; to-sorry 141:10 travei 7:2; 9:3; 10:9; 11:5
73:10; 75:4;77:13; 80:9; 153:17,20; 154:16;
151:1,4,6,15, 17,22,24; to-thank 175:22 92:17, 19;104:23,24; 157:11, 16; 160:16; 161:4,
traveiing9:15 105:6; 120:20;133:5;
152:3,5,7,10,13, 14; to-that 209:10 12,20; 164:1,24; 166:10;
153:1,22; 154:3, 14,15, treat 8:20; 26:22; 29:12, 158:7;167:23; 191:5
to-the 203:8 24; 56:8; 205:9 181:12;182:15; 187:25;
15,25; 155:2,5,14,21, triais 24:3; 27:14; 42:21; 189:6;190:2;200:2;
23; 156:5;157:5, 12; to-thay %:18; 202:24 treetabie 43:13 45:13; 46:9; 48:16; 55:2; 201:18; 203:18, 20; 207:3;
:-x-% 5,7,12, 23; 159:3, to-we 204:2 treeted 14:7;20:7; 21:19; 56:13;68:4; 72:4, 23; 73:1; 208:5,18
5,21, 22; 160:1,3, today 6:17, 20; 7:20, 23; 27:22; 28:1; 33:8; 34:25; 77:6; 89:3; 92:12; %:1;
two-of 157:10
2,15,19, 25; 161:8, 9:7; 12:14; 15:3, 12; 17:22; 35:3, 6; 37:17; 38:7; 41:7, 101:18; 104:5; 120:15;
9,11,20, 25; 162:4,5,6,9, 18:5; 20:25; 22:8; 23:5; 7; 42:6, 20; 47:2,4,5; 121:1; 125:2,17, 19; Twodimensionai 79:7
11, 16,23; 163:4,8,11, 24:2; 26:22; 90:13; 48:21,23; 51:17,19, 2Q 130:19; 131:18; 167:20; two-month 152:15;
20,20, 23; 164:4,5,5,8, 148:21; 152:20, 23; 54:6; 55:15, 21; 59:8, 13; 177:11, 19; 178:8;17S1:1; 154:2
10, 13,15,20,21, 23; 162:22; 164:4,8; 187:6; 61:25; 62:11; 67:23; 76:3; 180:15;195:14;209:19, two-thirds 58:5;98:3;
165:1,6, 16, 17,22,24, \ 188:2;210:24 95:4; 98:3; 108:16; 120:2, 20 154:23:155:2
-r --

to--25 - two-thirde (34) Min-U-Scrin@
Optha.kic Drugs Subcommittee of the
Dermatologic and Opthaknic Drug Advisory Crete July 22,1998

typeA6:19; 97:24, 24; 15:4;56:14; 151:18 !9:19;31:12, 13;32:25; ery 7:16; 9:9; 11:19; risual 25:19; 46:14, 15;
122:11, 12; 182:6;203:4 mgradable 94:2 }4:11,19, 20; 37:13, 14; 3:20;23:17; 32:1;36:7; [8:7;49:11, 13; 50:13, 15,
‘-’- types 63:25; 192:4; ;3:24;59:16, 18;60:3, 1;, 7:20; 42:2;45:16, 25; 9, 25; 51:1, 5,9; 55:2,6,
mgradables 125:9
193:12 ;7:3;92:5,7, 12, 13, 18; 6:9;47:25; 54:21;60:24; !0 67:12, 16;88:3, 12, 14,
miform 100:23 [03:25;123:19; 124:25; 1:5,14, 14;62:8,13,14, 5,19, 22; 150:17,18, 22;
typical 29:1, 16;34:14 mileteral 28:5; 53:21; 8; 64:3;65:8, 13;66:2,3, 53:1,2,6,8,8,18, 23;
[25:3;131:15; 138:15;
typically 126:1; 157:7,9 51:25; 157:17 [42:7;146:25;147:9,18, 1;68:6;69:22; 70:18; 54:6,11, 18; 155:10,12,
mimaginable 159:13 !5; 148:2;154:7;172:21, 5:23;78:3;80:13; 82:6; !0;156:5,12, 14; 157:3,
Irrinfected 117:8,18 !3; 173:3,6,7, 10, 13; 3:22; 85:23; 89:21; 2; 190:4; 1%:19
u
minterrupted 152:24 [75:10;180:23; 184:11, 11:13;92:16; 93:8, 22; Iisual-subject ive
!2; 185:23,24; 188:8, 15; 6:6; 99:14; 100:7; 102:6; %:19
UC-San 95:18 mit62:15
L94:7,8,9, 11;208:23 03:4; 106:6 109:22; fiiravene 6:6; 70:25;
Jnited 11:6; 12:2(3
UCLA 111:18; 113:22 Jse-the 147:18 11:24; 116:2!1;117:16, 77:12; 191:17
M:18; 162:21; 192:2,4
ultimate 148:3 lSd 22:1;25:10;30:12; :3;119:23; 120:19,25; dtreei 38:25; 39:14;
mlverse 100:18 22:21, 25; 123:5,13, 14,
uttimeteiy %:19; 133:1; (2:10, 11, 13;48:13; 74:2; i5:24
University 4:2o, 22; 10:3; 5; 124:15,16, 18; 125:12;
175:10 12:13;88:16;92:4;99:20 dtreal-the 65:23
!2:16, 17; 56:4; 162:24; 26:24; 128:2!4;130:6,13,
unable 73:17;82:23; [74:3 ~04:25;115:9; 118:15; dtractomy 44:20
~25:3,6,7; 142:25; 169:2; q 131:7,22; 133:2;
88:20; 115:9; 142:8 mknown 100:2 dtr-us 39:4, 12;40:3,6,
~73:20;175:1!+184:9; 39:11, 13; 141:13,25; ‘;42:14; 45:23;46:1;
unacceptable 170:18 Jnlees 112:25; 122:24; 42:10,19, 21; 144:7;
186:11;205:8,19 i3:lq 137:3
unapprovedhrew 188:6 [87:19;191:3 47:1, 1; 14910,22, 22;
JSefUl7:16; 13:17, 18; dtri-retinal 63:21
uncertain 180:1; 181:1 miess-there’s 193:2 70:10;98:12;99:20; 50:17, 23; ltn8; 162:9
67:11; 168:15; 1699,19, dtritia 42:13
uncertainties 188:13, 14 Jnlike 150:23 107:12;173:21; 183:10,
9; 173:9,12, 14;175:15, dtro 172:7
uncertainty 146:12; mlikeiy 89:21; 119:24; 13;185:21;1%6; 187:22;
180:25; 189:10;204:4 K)15:16 7; 1764; 180:11; 184:10 IOICE 151:12
~72:16
/38:8:~Q3:5,8; 194:1; roluntary 151:14
uric; -* p ;:7 mlucky 134:16 Jser 186:16 95:14; 1%:1; 197:2,3,
uncomfortable %:13; repopulated 65:15 Jses 188:6 !1;20(klq 206:1; 208:19;
208:5 using 16:9;46:15, 19; !)9:25; 210:14 ::;?; :e9;:9;;
,mresponsive 38:18
!10:2
uncommon 48:6, 6; mtil 28:22; 66:11; 137:2, i8:14; 123:8;125:1; rery-1 61:4
,/ rotad 210:5
171:25 5 166:12,12; 170:24 Fessel 85:2CI,21,25;
usually 35:3; 43:12; Totes 204:20; 207:3
uncommonly 46:23 mtreeted 28:5; 38:5; 16:3,6,18,22, 24;87:3
_—___ fl:7; 47:2; 54:25; 184:21 i8:ll; 157:10 fOting 207:12, 13
uncontrolled 21:20; !essals 84:1.7;85:3,22;
27:23; 28:2; 33:8; 34:25; wmsual 73:24; 97:24 uveitis 42:10,10, 12,16, 16:19,25; 12:2:20,21
37:17; 42:20; 47:4; 48:23;
55:15
unwilling 83:11; 95:9
19,23; 43:2; 44:8,9,18,
24;51:21; 52:1; 63:23;
Rated 11:9 w
Up 9:23; 10:2; 42:3; 48:4; fish 170:23
unconvinced 147:23; 124:22; 149:9
5012;57:23;
63:2;
68:5; uveitishitritis 44:19
riew 69:18;79:24; 83:15; ~alked 153:12
160:17 77:7,
13;
79:20;
86:18; 14:9;89:4;97:25; 134:19; walking 9:23
under 36:10; 37:20; 37:3;
93:25;
94:5;
103:25; [41:25;144:1LO; 145:2,5;
163:15; 179:23; 194:24
under-reporting 53:11,
108:15;
119:2;
112:25;
122:7;
118:2,7;
129:2,9,17,
v [69:19;172:15; 173:19
uant 6:24; 43:16; 44:17;
jl:22; 53:22; 56:23, 23;
[79:14, 18; 1B5:16;189:8, ;1:4; 62:23;70:2; 81:14;
18 21;
132:2;
134:5,7; !; 191:14,16 33:2;95:12; 100:1;
undergo 117:9 136:14; 143:10, v 5:5
138:21; /iew-even 172:14
19;
145:13; 155:1; vacuum 122:2; 206:3
154:5; 102:14;105:9, 16; 1iO:13;
underlying 41:19 /iewed 98:5; 128:6; 118:7;121:4; 124:23;
161:13;
173:23;
175:13; value 37:9; 122:24; 133:24
underrepresented 179:13;
180:23;
184:3,
3; 138:13,14, 16; 168:17 126:14;127:25; 132:12;
69:21 186:4;
187:13;
188:11; variability 75:7; 100:19, tiews 81:7; 83:14; 129:6; 136:15;137:16; 154:3;
underscore 43:16; 52:21 191:18;
194:25;
203:8; 19; 101:1 177:6;188:1:2;207:24 156:18;167:6;170:1;
understand 62:24; 204:202096 tiral 11:2; lti18; 92:20; 173:17;175:3; 178:14;
variable 92:3; 137:24 179:13;185:20; 187:11;
94:24, 25;95:14; 121:6; up-well 94:5 23:1,5;95:13, 14,16,19,
128:12; 130:6; 131:1~ variation 101:9,9; 23,25; %:5; 138:2; 139:7, 188:4;189:15; 193:18;
upon 6:10; 17:15;64:13; 197:16 198:5;199:8,21; 202:8,
145:25; 146:7; 147:14; 18; 140:5, 23; 146:8;
95:16; 101:24; 141:12; 17;205:22;206:7,21
153:14,25; 156:10; varies 178:22 191:1; 195:16
171:10 wanted 9:16; 10:19;
158:13; 164:23; 177:24, variety 16:5;73:16; Virginia 4:14
24; 187:6; 190:2; 198:25; upper 49:13; 51:12; 52:2, 77:21; 162:19 23:21;57:13; 60:18;
5,8, 14; 53:14; 54:7; Virtually 35:2; 66:4
199:15; 202:20; 205:18 various 13:12; 32:11; 61:17;71:14;85:7;94:1;
58:12,15 virus 16:25;19:9;40:8; 137:22; 138:17; 158:12;
210:12 34:13; 36:17; 44:1; 49:14;
upswing 60:7, 11 171:18,20 168:5; 174:6,20; 209:14
understand-and 66:17 61:4; 6622; 164:14
upteka 39:1,4, 19 Vision ‘7:1;22:20;46:7, wants 154:14
understanding 77:2; vary 79:23; 84:5,13 10;48:6; 50:24;55:5;
94:20; 105:19; 127:1; US46:8; 57:10; 59:22; vascuiitis 85:22; 87:1 was9:3,8, 10,14,17,18,
151:1; 154:22;156:6,7,
177:10; 180:25; 190:7 62:14; 67:1,2,6, 9; 70:10 24; 10:2,10,11,12,12,
Vermeer 11:5 14,17, 25; 1(59:16;170:14;
understood 158:17 98:22; 102:19; 107:22; 17; 12:25;13:4,5; 22:17;
.—.. version 150:3 171:3,24; 172:17; 173:12;
115:2, 2; 116:6; 121:17, 23:13, 17;24:23; 25:19,
undue 101:6 versus 21:22; 28:3;
182:1,8 21; 26:3, 24; 27:2, 2;28:5,
24; 122:1; 124:5; 126:16;
unduly 56:25 133:25; 138:9; 145:18; 32:20; 35:8; 36:22; 122:7; visions 9: 1!3 6,7,8,10, 24;29:3, 11;
unevaluable 95:5; 164:17; 169:24; 174:11; 127:14; 128:23; 130:23; ViSit 25:16; 26:25; 27:3,7; 30:5,9, 19,21;31:2, 13,
115:10,13,14,22, 25; 177:16; 182:22; 183:12; 133:3; 159:19; 179:17; 45:18; 85:24; 91:10; 18;33:11, 13,15, 16, 17;
116:1o, 11, 16, 17; 118:8 193:23; 201:24; 202:17; 180:23; 190:19; 193:19; 114:13, 15; 1[18:2;150:19; 34:11,16,19, 20;36:11,
unexpected 127:12 205:2; 209:23; 210:1 208:1,6 154:25; 157:4 13,16,22, 25; 37:5, 23;
unfortunately 6:2o; use 8:1:16:14.16:22:10: versus-730 128:23 visits 43:12;82:23;90:19 38:1,6, 18;41:20,20;

Miller Reporting Company, Inc. Min-u-scriSBt@ (4<1 Iwfie. =70C
Opthaknic Driug8 Subcommittee of the
Jdy 22, 1998 Dermatologic and OpthalmiC -g Advisory Crete

42:2, 14;43:3, 10, 15; Watson-Crick 16:11,15 13, 14, 15,17,22, 23; 23; 79:13,13, 18;80:10, 91:2,4,6,8,12,18, 20;
44:7, 19;45:4, 13,16,16, way 4:10; 13:15; 15:23; 143:1,4,7,11,13,15,17, 17,21 ;88:2 92:8,10, 17;94:10, 11, 16,
_e=74; 46:5,16, 20;47:3, 47:12; 48:5; 53:4, 15;61:5, 23; 144:1,13,15,18,19, WGdCS 10:15,19, 24; 18;95:8;%:12, 24;98:12;
:5,6, 12;49:19; 22; 64:18, 18;74:20; 20, 21; 145:3,7,10,12, 28:19, 21;34:2, 5;78:15, 103:9,12,18,20, 25;
.7, 18,22; 52:4,5, 11, 77:10, 20; 80:2; 82:3, 16; 17, 21; 146:7,15,20,22, 16;81:19;85:13,24; 104:20;105:7; 107:18,23;
19,22; 53:14; 54:8; 56:4, 87:3; 93:14; 100:16,17, 25; 147:3,4,8, 22; 148:24; 103:3; 106:22; 127:15; 108:3,4; 109:6,8,8, 18;
5; 59:6,7,16,16, 23; 60:6, 18; 102:10,11,16, 17; 149:1,10; 15016; 151:16; 136:17; 137:11; 165:18 111:9;113:8, 12,14,16,
23;62:21;66:13, 14, 19; 103:7; 104:6; 107:7; 153:1;154:10; 155:6 weight 148:20 16,18,21,23,23, 24;
67:12,19 ;68:2,4; 70:21; 112:17; 121:10; 124:12; 156:21; 157:11,24; 114:8,9;115:5,6,7,7,8,
158:25; 160:9; 161:9,13, welcome 4:2; 12:11;
71:20,21,25 .25;72:1,3, 127:17; 128:20; 129:3,5, 10; 116:7,9,10,11, 12;
17, 17;162:1; 163:11; 13:19
14,22;73:1,9, 11,24, 17; 133:12;141:10, 12; 118:5,9, 10;119:7; 121:6,
74:4,6,9, 11;75:4,5,7,8, 164:10, 24; 165:13,15, 16; well 20:16, 24; 21:6; 7; 122:5,21; 123:14,25;
142:12;145:10, 13;
24;76:9,9, 19;77:4,6,8, 166:6,8,10,17,19,20, 25:12; 45:9; 56:22;62:1, 126:15; 127:19,25; 129:5,
147:19,23; 148:3; 153:22;
11, 11, 12,21,25 ;78:13, 20,21, 24; 167:1;168:7; 18;66:10; 68:1; 69:1,:11; 13, 14; 130:2; 132:2,3,17,
154:15;155:23; 156:8;
19,19, 22;80:2,2,3, 7,8; 169:14,20,24, 25; 170:2, 84:9; 95:11; %:3; 101:3; 18,18,23, 24; 134:9;
159:12;160:21; 161:25;
82:23;83:1,3,6,11,15, 3,4,5,12,14,17,20,23, 106:18; 112:19; 113:20; 138:2,4; 139:14, 15;
170:5; 175:18; 176:20;
17;84:11;85:18;86:3, 13; 25; 171:1,6,9,12,17,17, 116:25; 120:16; 122:9; 14018,22, 23; 141:7,14,
180:3;183:1;203:16, 23;
87:14,19, 22;88:14,20, 18,19,20, 22; 172:4,6, 123:20; 125:5; 131:16; 20, 21; 142:8,10,11, 24;
204:3; 205:6,8,9; 209:15, 13, 19;173:9,10,14, 18;
20, 21;90:23;91:1, 19, 24; 134:23; 139:5,9, 25; 143:7, 17; 144:20,21;
19,19,20 174:24; 175:17;176:16;
92:3,9,11,11,13; 94:1,4, 144:16; 147:14; 151:10; 145:18,23; 146:3, 15,20;
ways 47:15; 103:12; 177:13; 178:16;179:17, 155:19,21,22,22,24;
25;95:6,7,8, 9; %:16; 199:6 147:5;149:4;150:1,3,7,
18; 180:7,22; 181:12, 14; 156:9, 12; 173:2,6;
97:12, 15;98:15, 23; 182:15, 16; 183:2,5,11,
9, 14,21; 151:23;152:1;
ways-disappeared 176:20; 177:10;178:6,10,
103:13,24; 104:25,25; 153:2; 154:19,21; 156:3,
166:23 18;184:4,8,17,20, 23; 25; 179:9,20; 180:5;
105:18,22; 106:16,16, 24; 186:1,21, 24; 187:19,21; 22; 157:2,4,6,7,9,21, 25;
107:10;108:8;109:15,15, ways-things 103:18 182:25;183:6:184:5, 10, 158:2,4,6, 19; 159:3,7,
188:1; 189:19;193:2,7, 19;185:6, 18;188:11;
24;110:1,2,4; 111:11 “z; we 4:9; 6:1,7; 7:4 7, 14, 13, 25; 163:4,25; 164:13,
12; 195:6, 14; 1%:18; 189:17; 190:3; 191:13;
112:1; 113:15,17,21; 19,24;8:2,7, 11,14, 15; 14, 18; 165:3,23; 167:10,
197:25; 198:23;199:5,6, 193:13;195:4; 1%:6, :25;
114:14,17,20 ; 115:9,13, 12:13;13:9,13,14, 15,20; 11,15, 22; 168:8; 16$11,
15, 18;200:11,12,12,13, 197:11;198:7, 14;204:1,
15,22; 116:21;118:8,15, 14:22;15:5, 11; 17:25; 13;170:14,24, 25; 171:13,
14,15, 19;201:19;202:23; 7; 206:23; 207:15;20$:4,
, -18,18,25; 119:1, 13,19, 19:6;20:12,13, 23;27:5; 14, 19; 172:9; 180:8,8, 22;
203:1,14, 17;204:23, 24; 16,23
20,21, 25; 120:20,20; 28:11,11 ;29:17;30:12, 183:2,22; 184:5; 185:16;
205:2,5,8,9,12,14,17,
121:8,10,16,16,20, 23; 23; 32:5,5, 19;33:2,4,5; well-and 155:1 195:14;196:9; 198:8;
20206:4,4,5,6, 20;
s~-14, 14, 17,25; 123:5, 34:20; 35:21;36:5,19, 21; 207:23; 208:15;209:6, 22; well-being 11:18 199:1;202:25;203:1;
24:2, 12;126:9, 10; 38:24; 39:7, 17;40:4,17, well-known 20:2; 93:4; 204:11,13, 13;208:11;
210:1,6,17
.14; 129:2,5, 23; 18;41:23;42:10, 11, 13; 210:21
We’d 57:8; 173:25 139:14
130:1;132:1, 1,2,5; 43:6, 8; 44:17; 45:20; were-l 126:6
46:13,14, 17;47:17; 49:1, We’ll 6:12; 12:8; 13:21; WG1l-pt)wered 192:13
133:9,24; 134:15;136:14; were-which 113:11
8,12,18, 19;50:21; 52:21; 2024; 21:7; 24:4, 6,7; want 9:17; 66:12; 94:19,
138:9,10,22, 22; 139:6,7, were-who 161:22
$3:10,15,23; 54:1,5, 13, 49:7,10,13, 17; 51:11; 21; 103:1,3,4,6; 107::21;
23,25; 140:9,21; 141:12;
14, 24; 55:2,7,7; 56:14, 112:25; 133:18; 135:7; 108:5; 114:13; 138:21; weren’t 67:22; 104:17;
142:4,6,7,19, 20; 143:4,
17, 18;57:2,8, 11;60:1,3, 136:3,7; 154:4; 173:14; 141:18, l% 143:19, 23; 129:13; 136:9; 144:20;
6, 25; 144:5,13,15, 19;
7,19, 19;61:17, 21;62:9, 175:24;206:21, 23; 207:4 144:12; 151:7; 153:7, :22; 158:4,8
145:11,25; 146:1,5, 20;
13,13, 17,21,23 ;63:18; we’re 22:9 24:25; 27:12; 154:25; 161:1o; 165:25; what 12:18; 13:17; 15:5,
149:24;150:2,12, 13, 18;
64:16; 65:10, 10;66:8,10, 98:16; 101:17, 18; 102:20; 167:8; 168:17; 171:22; 7; 27:16; 29:5,13, 18;
151:13,18,21,24; 152:8;
24;67:4,7, 16;68:5,5,13, 103:24; 104:4, 14; 10620; 179:17 30:24; 31:12; 32:19; 39:2;
153:3,9, 11;156:1,6,7,
14,24, 24; 157:15,15, 20; 13,23, 24;69:20; 70:10 109:23; 110:14; 124:14; were 9:19; 10:6,8; 12:23, 40:11;41 :4; 47:7, 17;
158:9,11,17,17,22,23, 71:7;72:10,16, 17;73:14, 128:10; 130:2; 139:3, 12; 24; 13:2; 23:2; 25:10, 1~5, 49:11, 16;53:18, 25;
24; 159:3,5,11,11,22, 22;82:3, 14;84:7;85:25; 148:21; 151:9; 160:22; 16,20,25, 25; 26:8,9,10, 54:23, 24; 55:24; 56:15;
23; 160:13,15; 163:13; 88:20; 89:2, 22;92:20; 161:3; 173:5; 181:18; 11, 11;27:6,7,9; 28:2,16, 57:9,10, 25; 58:2, 2; 59:8,
166:11, 18;167:12,13,14, 94:17,20,22, 22;%:1; 182:12; 183:4, 16; 184:1; 21,22, 23;29:17;30:14, 22,25; 60:5; 61:13;63:12;
16, 19,20; 168:9, 10,11, 98:6;99:1,2,9,10,12,13, 190:13, 14;193:6, 16; 25;31:6,6,11, 17;32:5,8; 64:15;66:19; 67:14, 25;
12,14,17,23, 24; 169:3, 14, 22; 1W1O; 101:8; 194:6;205:6,7,10,10 34:2,6,8,10,18,24, 25; 75:8;77:25; 81:6, 8; 82:6;
6,13,15,16,19,20,20, 102:21;103:1,9,25, 25; 210:23 35:1, 21; 36:15,23,23, 24; 83:1, 3; 86:13; 87:8,16,
21; 170:4,5, 13; 171:4,5, 104:1,2,3,4,6,21, 24; We’ve 11:21;22:12; 37:4, 12;38:1;39:23; 19, 20; 88:6, 8; 89:4; 90:3,
16, 18; 172:25;174:20; 105:1;106:21; 107:2,17, 48:22;62:17; 65:8;82:13; 40:19, 19,25; 41:1, 10,14, 6,8,9; 91:9,21 ;93:2,11;
175:5,6,9, 14;176:21,22; 18,21, 24; 108:1,3,5,15, 88:16;99:12, 18;100:8, 15,18, 25;42:6, 22;43:6, 94:13; 95:3; %:17, 25;
178:22;179:20;181:16; 15, 17;109:23; 111:20,22; 22; 108:14;111:4; 126:1; 8,14, 25;44:1,3,20, 23; 98:7, 23; 99:25; 100:16;
182:24,24; 183:1;185:9; 112:2,8, 12; 113:21,21, 146:21,21,24; 147:4; 45:1;47:3,12,18, 23; 101:2, 5,7; 102:8; 103:20;
189:12;191:10,20,21; 23; 114:6,11, 12;115:9, 155:13,24; 163:6;166:16; 48:7,10, 10;49:25; 501:1; 106:2; 107:2; 111:4;
195:16;196:9,18, 21; 14, 19; 116:11,12,13, 14; 171:8; 172:11,15, 17; 51:1, 19;58:8; 59:12, ’13; 114:5,6; 115:14; 118:15;
197:11,15,20, 24; 202:23, 117:20,21; 118:1,3,4, 20; 177:14;187:24;190:15; 60:6;61:12,19, 19;62:13; 119:8; 120:9; 121:9, 24;
24, 25;204:10, 10, 14; 120:14, 17; 121:10,12,15, 191:13;198:19;207:12; 65:4;67:7,15, 16;68: 16; 122:7,7, 14,23, 25; 124:2,
206:11;208:12,13; 17,17, 19; 122:18,18, 21; 209:2 69:9,10, 16;71:18, 22; 6; 125:18; 126:1, 14; ~
----- 11,12 123:4, 18; 124:6;126:3; weak 74:25;204:16 72:5, 13,14, 18,24, 25; 127:19; 130:7; 133:13;
-a 159:2 127:1,9, 17; 128:11; 73:12,14,14,17,18, 2!1; 136:15; 138:9,12, 18,22;
130:14,21;131:1,2; week 10:13,20; 33:25; 74:5,7,8,9, 20;75:6, 10; 139:6,9; 140:16; 141:7;
..aS-yOU 84:21 132:3,25; 133:5,7,7,13, 49:3, 4; 81:20;82:1,2,4, 76:2, 11,17 ;77:1,4, 14, 142:6; 145:11; 146:6,8,
Washington 56:5;65:8, 17; 134:11, 16;137:18; 5,7; 84:22; 85:24; 103:2; 17,18;78:21;79:11; 20; 147:4; 148:21; 149:1;
9, 13 138:20,23; 140:3,12,22, 107:25 80:10;82:24;84:2; 85:11, 150:1,2, 18,24, 25;
wasn’t 65:24;67:22; 24, 25; 141:2,5,6,8,10, week-to-week 108:7 22;87:12, 21, 21;88:81,13, 151:11; 152:4; 153:15;
118:22;157:14 12, 15, 16; 142:3,6,7,10, weekly 28:18;78:15,22, 22;89:17;90:6,7, 17; 155:8,25; 156:1, 13,24;

was--a - what (36) Mill-u-scrhtfa
Opthal.mic Drugs Subcommittee of the
Dermatologic and Opt.halmic Drug Advisory Crete Jtiy 22, 1998

157:L5; 158:12, 13; whether-again 150:24 94:25;
101:21;
120:24; 8,11, 22; 203:1.4;207:2, 24; 208:5, 10; 209:6, 18;
159:25; 161:23; 169:10, whether-as 95:3 123:3;
124:20;
128:17; 18,21, 23; 209:4, 17; 210:16,19
.- 19, 23; 170:2, 12; 177:25; 130:14,
15;
132:17,
18; 210:3,5,25
which 5:21; 6:1;7:3; with-i 172:25
178:2, 22; 180:10,12, 13, 11:17; 16:3; 21:15; 24:21; 134:11;
139:24,
25; Wisconsin 22:16 with-or 67:16
20; 181:17; 183:9,24; 26:4; 32:5; 45:4; 50:21; 151:10;
160:6164:17,
20; wish 6:1o
184:11;188:1; 189:13; 169:7;
185:20;
191:21; withdrawal 44:16; 146:5;
52:22; 54:14; 67:24,24, wished 126:16 151:15
190:21;193:10;194:6,21; 24;6?:25; 70:22; 71:7; 194:10;
206:13
195:16; 197:10, 11, 15; with 5:12, 25; ~5:7,9, 23; withdrawn 140:15;
72:1; 74:18;78:22; 84:11, why-194:24 7:6, 22; 8:2,6,8,13, 16;
201:25;202:20; 203:1, 11; 18;89:16;93:14; 95:21;
146:3; 210:18
wide 93:22; 100:8 9:8,10,11,18,21, 23;
204:19,21, 25; 206:14,16, 98:12; 99:2, 3; 100:3; within 30:20; 43:4, 10;
21; 207:2;208:17;209:23; widely 131:17 10:2;12:24; 13:3;15:8, 13;
108:9; 110:10;114:16; 81:11;93:14; 95:25;
210:1,23 wider 100:9 17:11; 18:7,17,18, 21;
118:9,11, 15;120:1, 17, 19:6,7,9,13,15,17,20 140:12; 174:18; 178:21;
what’s 15:2;17:22; 20; 126:9,20, 21; 128:11, Wife 65:5; 181:16 184:17; 185:25; 186:1,9
20:7, 19;21:2,5,18, 19;
58:11;64:13; 107:8; 11;133:13; 136:20; 141:5; Wiky 5:1; 105:15; 127:8; 23:6, 25; 24:2; 25:19, 25; within-between 101:1
126:12;128:15 149:14;151:21; 152:4; 129:1; 178:17; 182:21; 26:15,25; 27:14,18,21, without 11:7,7; 15:22;
whet-how 183:11 162:25;163:25; 165:9; 183:16 23; 29:1,17, 21.;31:4; 21:4; 32:24; 43:16; 44:15;
whet-1 202:20 167:10,21; 168:1; 169:15; Wiiey’s 101:20; 106:9 32:13,17,21, 2!4;33:5,14, 56:8; 65:4; %:7, 17; 110:3;
whatever 61:18, 19; 174:7, 18; 175:3, 18; wiit 5:8, 23; 6:3; 7:16 17;34:7, 15;35:3,6; 119:16185 :11;201:13
87:18; 126:22;156:18; 182:3; 184:23;186:12,23; 5:15, 15,21; 10:14; 14:10, 36:13;37:2,4,17, 22; Won’t 56:1; 172:5;
183:17;190:16;208:2 187:10,21; 189:19; 12, 13,22; 21:12, 25;22:3, 38:8;39:11;42:3,10,18, 187:20;200:5
whatsoever 58:22 1%:14; 197:24; 198:2; 3, 14;24:2,10,11,18,22, 21;43:9, 13;44:13, 18,23;
45:12,22, 24;46:9, 16; wondered 6712
200:8, 12;203:3; 206:5,6, 24; 26:22; 27:5, 16; 29:5,
When 9:16; 10:13; 23:10, 47:4, 11,14;48:11, 12,22, wonderful 9:21; 23:18;
10;207:5,11,25 7,13, 21; 32:2; 33:9;
19;31:15,20; 38:1, 5; 24;49:7, 22;50:3,7,8,9, 65:2; 124:5
40:17; 42:11; 44:6 46:13; whichever 57:20 34:21;35:11;38:22,23;
While 7:18; 39:17; 40:25; 40:11,16;41:4,11; 42:4, 23;51:7, 24; 5;!:4,10,12, wondering 98:16
48:17; 56.-1,61:3; 62:10; 21;53:14,17, :!1;54:13,
41:9; 56:17;79:21; 82:2, B;43:18; 48:9; 57:11; 124:16; 160:2; 162:13
81.2; c3:20;8+:3; 86:20; 14;55:9,9, 21; 56:9,11,
90:14;92:11;93:13; %:2; 17;97:7, 13;98:1; 110:5; 63:19;64:5,7; 65:22; word 178:6,8,15, 16;
126:5; 128:6; 138:25; 69:24;70:16; 71:10, 11; 12,22; 57:3,17,21, 22; 191:7, 11; 194:23
113:23; 114:18; 115:13, 58:6,24;60:14; 61:11,21;
16, 19; 116:3; 120:15; 139:4,5; 143:19; 154:10; 74:16;79:13; 81:13; words 30:14; 34:10;
,/ 68:18,23;%:19; 99:20; 62:11,12, 22;63:24;
123:11; 129:10; 141:20; 158:2; 162:8; 167:8, 19; 81:25;92:24; 171:12; ,
106:2~ 117:21; 126:11; 64:20,21;65:4:,9, 17;
142:5,16, 18; 143:1O; 180:1;200:4 178:14; 179:5;208:1
133:19;137:4;146:16, 19; 662, 4; 67:20, 23;68:3,8,
-~ 144:23; 145:14, 17,23; White 50:18; 117:8,9, 10; 9, 19;71:2, 13,16, 16; work 4:9; 15:23; 23:13,
- 158:8,17, 21; 159:2; 122:21; 131:4; 186:18 155:22;162:10;173:12; 16; 57:3;71:13; 77:22;
174:2,8; 175:12,18, 18; 73:13;75:15; 76:19; 77:9,
166:6; 167:11; 168:11,13, whiteness 117:7; 122:16 22;78:9; 79:23;80:3; 120:14; 128:4; 130:21;
18; 184:4;194:9; 195:9; 178:4;179:5;186:4,5; 137:7; 171:16; 195:19;
who 6:3,18, 19;7:8, 9,9; 187:19;194:4; 195:10,11, B2:11,19;83:14, 19, 20;
200:11;204:22 8:19; 10:5, 24; 14:9, 11; 90:16;91:9,1$$93:1,7, 206:22
when-and 199:10 19; 199:5,20; 200:12; worked 61:10; 135:1
23:24;26:5, 24;27:3; 201:20;206:14, 15;207:6; 10, 22;94:13; !?5:13;
when-1 209:11 29:12; 3014; 34:2, 25; 209:2 %:13, 21;97:8, 9; 99:2,3, working 23:25; 56:22;
when-you 180:9 36:7, 22;37:3;39:8,8, 24; 4; 100:3, 16; 101:10; 137:9
4019; 4419, 21; 52:13; wiliing 95:6; 173:25; 102:15,23, 23; 103:7;
where 10:19;35:22; 175:19 works 185:13
41:23;42:5; 54:1;64:1; 5619; 58:11;59:12,12; 104:16,18, 22; 106:15,19, workshops 166:21
60:11, 17;62:1963:19, Wii!S 12:3 25; 107:2,8; 111:6, 13;
65:10;74:9;80:16; 81:10, world 64:18;65:ll
11, 18;83:3,17,20, 25; 21,21, 23;64:13, 14; WILSON 4:2,19, 19; 5:8, 112:13,21; 114:8; 117:14,
65:18; 67:19;76:2;92:24; 10;6:12; 8:25; 11:20; 12:5, 23, 24; 120:1,16, 18; worldwide 191:16
84:2, 3;85:3,8, 21;86:15;
87:13;90:22;91:2, 7; 97:22; 109:7;113:1,17, B,10; 13:21;57:11, 19; 122:10; 125:18,21; 1262, worries 64:8
92:13;94:17;95:2; 103:3; 17,25; 116:22,25; 119:5; 59:2;61:23; 63:1;69:23; 12,14 ;12810; 1294,15; WOrry8:14
115:12; 116:9,20; 122:20, 120:9;126:16; 127:25; 70:16;89:25; 91:25; 131:17;133:18,21,24; worse 10:15;50:14, 17;
20; 124:16;129:8,10,16, 131:17; 137:5;139:14, 15; 93:24;95:10; 9923; 134:6, 16; 138:14,23; 74:18; 155:23;156:15,18
20,23, 25; 130:13; 131:3, 140:4; 149:4; 150:6, 13; 101:11, 14; 103:11; 139:3,13,14, 17; 140:11, worst 155:23; 156:7
19; 139:13;141:24; 151:25; 152:24;154:18; 104:12;105:12, 15; 106:6; 19; 141:7,12, 20; 142:3;
156:22;157:25; 161:16, 112:16,24; 113:4;118:7; 144:24; 145:12;147:4; worst-case 49:15; 51:11;
153:18; 158:14; 163:8; 52:24
164:15; 178:17; 180:8; 22; 162:17,21; 165:7; 119:4, 11; 121:2,22; 148:21;154:5; 158:6,23;
171:13; 173:20,24; 124:19; 125:14; 126:13; 160:1,7,10161:9,14, 16; worth 80:24; 107:1;
188:19,22; 189:25;190:7;
174:16; 179:5;182:2; 127:3, 5,8; 129:1; 130:4; 163:15; 165:17,18, 19; 126:22
193:11;202:24
184:6;187:7, 11;190:19; 131:10,23; 132:7;135:6 166:21; 167:25; 168:23; wouid 63; 8:11; 9:12;
whereas 169:6 136:3,7, 11;137:14, 16;
191:9; 192:4; 194:7; 169:11, 16; 17’0:18,23; 10:18, 18; 11:21; 12:5,10,
whereby 116:24 195:16, 18; 198:11; 138:25;139:5;147:5, 12; 172:8,21, 22; 173:22; 18; 13:7,16, 18; 33:4;
whether 12:24; 13:11, 201:20;202:14; 210:17 148:12; 154:7;157:12; 174:14; 175:18,24; 176:8, 36:10; 39:19; 46:6; 50:21;
16;40:12;76:18; 82:24; who’s 11:16;63:14; 159:5,11,14, 17; 162:4; 16, 17; 177:16)19; 178:7, 51:15; 52:6,9, 24; 53:7,
88:21; 89:6, 7; 92:10; 93:9; 113:24; 191:8 164:11; 165:1;167:5; 8, 15; 179:1,2, 20; 181:2, 10; 54:1; 58:25;60:7, 21;
100:1;101:24; 102:1,19; 168:22; 172:18; 173:16, 11, 20; 182:2; 184:3,3,6; 61:7, 14;63:5; 65:12; 66:9;
whole 39:17;9716
105:1,9; 114:8,9, 14; 24; 175:21; 176:11,14,19, 188:13,20; 189:5,15, 21; 68:18; 70:9,9, 25;78:9;
102:25; 166:9,9; 184:24;
.F—’=.. 115:5; 121:9; 127:14; 208:7 25; 177:21; 178:4,10, 16; 190:13;191:61,15,15,20; 80:18; 81:8,12, 23; 82:4,
130:24; 132:5; 139:7; 179:3, 13;180:19;181:7, 192:15, 18; 193:10, 16; 16;87:14; 90:15;92:25;
142:6; 143:25; 148:22; whom 23:25; 107:22,25; [0, 14; 182:20; 183:8 194:4,21; 195:6; 1%:12, 93:12;95:17; 97:4, 5; 99:1,
156:25; 160:2; 164:2,3,7; 108:2 [85:5, 15; 188:3, 11; 17,20; 197:6; 198:18,25; 4; 101:25; 102:1, 5,7;
170:5; 178:21; 180:21; whose 6:9; 36:21; 43:7; [90:11; 191:12; 192:7,20, 199:13,18;200:5,6; 104:2,21; 105:6; 106:1;
182:13; 183:3,19, 20; 146:17; 190:18 15;193:14,20; 195:1,3; 201:14;202:14; 203:1,2, 112:16; 113:1,5; 115:14,
184:21; 185:2; 194:22,23, why 11:12;38:22;71:20; ~%:6;197:5, 23; 198:1,5, i;204:18; 205:3,6,11,11, 19; 116:16, 16; 118:13, 19,
24; 195:6; 1%:25; 205:1 74:i7, 20; 80:24; 84:12; ~3;200:19, 23; 202:2,4,6, 14;206:9,13, 22; 207:5, 20;119:1,8,9; 120:3, 5,6;
Miller Reporting Company, Inc. Ihm-u-scridm
optha.lmic Drugs Subcommittee of the
July 22, 1998 Dermatologic and Opthahmic Drug Advisory Crete

121:15,17,17,25; 122:19; 9:7; 11:19,20; 12:10, 11; 165:24; 166:16; 167:21, zero-at 163:18
1278, 15;128:5,20; 13:9,11, 20; 14:4,17, 19; 24, 25; 168:14, 18; 169:1, Zone 28:6; 33:11; 161.:23;
:-3; 131:12,14,15,15, 15:1,5,7; 18:9;20:24; 2,4, 7; 171:8,9; 172:6, 22; 162:2
33:6; 136:4, 11; 21:8, 12;22:3, 10;23:8, 173:6,16,17,17, 23; Zyloten 184:5,5; 194:11
5; 147:16,23; 148:9; 19,20, 20; 24:10,11,18, 175:13,20,21, 22; 177:17;
149:24;15017; 153:4; 20,22,23, 24; 25:2,6; 178:17; 179:18, 20; 180:7,
154:7;155:10;157:4; 26:13, 22; 27:14, 16;29:5, 9, 13,24; 181:1,2,4;
160:1,21; 161:13,24; 7,13, 17,21 ;30:2; 31:25; 182:23; 183:7,9,13,17,
164:3;165:7;166:3; 32:2,6, 14;33:9;34:21; 19,25; 184:5, 14; 185:9,9,
168:7,22; 169:23; 173:25; 35:9, 11;38:3, 21;39:2,2, 12,14, 16; 186:11, 15,16,
176:15;179:16, 17; 14, 16,20 ;40:11; 41:4, 11; 17,17,21, 22; 187:9, 16;
180:10,22,24; 181:1, 14; 42:3,4, 15;43:1, 18;44:6, 189:15; 190:20,20,21, 25;
183:9;184:22,22; 185:3, 8,17, 24;45:2,6,7, 10; 191:3;192:6,17,20,22,
11; 189:22,24; 190:6,8, 46:7;47:9, 25;48:8;49:11, 23; 193:8”194:2,4;
12, 24; 191:6; 192:14,20; 15,24; 50:10,12, 16; 1%:21, 24; 197:9; 198:5,
193:1,4,5,6, 12; 195:15, 51:15,22; 52:12,16; 11, 15;191,12,14,17,
21;1%:11,22; 197:1,3; 53:24;54:10,20, 22; 19,20; 200:4,6; 201:24;
198:24;199:2;201:21; 55:15;56:1Q 57:5,12,12, 202:17;203:8; 204:8;
203:3,5,6,15,18, 19, 19; 20,23, 24; 59:17, 25;60:2, 205:21, 22;206:14, 21,23;
204:1, 2,7; 205:2;207:5; 17,18,18,21, 25;61:6,7, 207:19;208:5,7; 209:22;
208:18;209:18,25; 13,25;62:9, 24;63:2,3, 210:5,13,22
210:22 11;64:7,8,9,10,17, 20; you’d 106:18
wouldn’t 104:6, 16; 65:14,20,21 ;66:3,5,8,9;
yOU’li 15:10;21:13, 16,
105:3; 125:7; 133:10; 67:21,21, 24;68:12, 25;
20;23:5; 40:17;51:14;
192:17 69:5,6, 22;70:1, 11,18,
70:12; 84:24; 85:2, 4; 87:3>
24;72:2;73:3, 5,9; 74:17,
wouldn’t-1 79:24 5; 102:12, 1~ 143:12;
18;75:11,12,19; 76:11,
wrap 188:11 191:5
12;77:25; 79:3, 13;80:13,
written 26:17;70:25; 16;81:10,11; 83:20;84:3, you’re 19:21;42:4; 61:6;
,305:23 7,12,15,16,16,22, 23; 80:23; 93:13; 103:20;
85:7,8,18,19,20,20,21, 122:23; 125:1,2, 10;
wrong 9:17; 74:22; 81:2;
171:4,4 22;86:6,8,11,19,20, 23; 126:2; 1294; 147:3;
87:8,8,17, 25;88:4,17, 152:5, 15; 154:10; 166:17;
--~-ng-there 126:19
18;89:24; 9Q1, 8,9, 12; 168:1; 173:3; 185:1;
91:12, 22;92:1, 15;93:7, 193:3,3; 209:24
Y 10,12,15,22, 23;94:10, YOU’W3 23:2; 73:15, 20;
11,12,13,14,15 ;%:11, 78:13;8(Y6;%:25; 98:1;
12,22,23, 24;97:16,19, 106:2; 142:3; 187:19;
Yeah 190:23
20;99:3, 11,21,25, 25; 199:22;2(M 1
year6:23; 22:2o; 55:1;
69:17; 150:7; 162:25; 100:1;101:2,3,11,21,
102:14;103:15,16, 22;
24; yOU-if 129:16
163:9 you-it’s 66:3
104:11,15,17,17, 22; yOU-nlSy 24:2
Year’s 9:17 105:7,7,9,10,17, 19;
years 9:6,8,10; 10:12, 106:6, 14; 107:1, 17; you-one 174:6
17;11:1; 12:15 ;18:11; 108:19,25;109:21; your 12:,2; 14:5, 13;
191,5,24 ;22:18,23:11, 110:23;112:24,25; 113:5, 24:21;42:5,8;4913;52:1;
13,14;40 -’30.11; 6,8,11,11,12,14,15,16, 58:1;61:25; 64:9, 15;
69:15; 112.20; 117:15; 17, 17;115:1,3; 116:5,6, 66:11, 18;68:8, 18;70:1,
121:21; 126:24; 149:12, 8; 117:23,24; 118:6,8,10, 4,5; 75:22; !XllO;%:4,
20, 21;162:9; 164:1 12, 13; 1192; 120:3, 12; 10,22,23, 24;97:20; 99:6,
yellow 50:20; 51:6; 121:4,9122:2,6,9, 14; 19;100:2,6, 10;101:7;
156:19 123:21; 124:4,13,16,18, 105:19,22; 106:10, 12;
yes24:11,11,12, 13; 23, 25; 125:2,10, 25; 113:8; 114:20;116:5;
121:25;124:12; 127:21,
38:12, 14;54:4, 15;55:4; 126:6, 11; 127:8,10,20, 25; 129:6;131:12; 134:3,
58:19; 61:24;66:20; 22,22, 23; 128:17,22, 25;
21; 135:1;136:20,21, 22;
76:14 ;93:25; 112:18; 129:2,10,16,17,20, 20; 137:1, 17;142:14;147:12;
113:10; 114:22; 119:6; 132:2,7; 133:14; 134:25, 154:5,16, 17; 157:16,17,
132:9, 21;138:17; 148:14;25; 135:2, 2; 136:11,25;
154:12, 13;155:4; 157:14;137:1,2,14,15, 22; 138:8, 17; 161:25;169:6,9;
158:20; 165:1; 168:22; 9,19, 24; 139:9,21; 1407, 172:25; 175:21; 18&20,
169:8; 170:9; 176:4,4,12; 7, 11; 142:5;143:5,5, 14; 21; 183:9, 14; 186:20;
177:22; 178:19; 181.7; 144:5,23, 23; 145:9; 187:9; 188:4;197:10;
183:16; 199:3; 202:22; 146:1,10, 13; 147:3,5,7, 199:21;200:5, 19;206:22;
.e-<:20, 24;207:4,10 9,10,19, 19; 148:12; 207:19,24
150:3; 151:3,4, 16; yourself 136:11;199:23
mo 207:3
152:10,10,14, 14; 153:7,
11:3;
96:20; 101:19; 12,12, 25; 154:3,7, 18;
134:2,
14;
18;157:16;
206:16,17
204:11,155:3,3,10,13,20,20, z
22, 25; 156:4, 11, 18, 18;
York 12:1 157:15>15,16,17, 22; zero 11:1; 43:9; 166:4,5;
YOU 5:10;6:11, 15;8:23; 16(k2,&9, 11; 164:17,20; 167:4

wouldn’t - zylotan (38) Min-U-Sciipt@ Miller Reoortimz (%mnanv. TmC