BrainO Tech Inc.

CTD Module 1
BrainO

Cover Letter


February 20, 2003

Robert Meyer, MD, Director ORIGINAL NDA
Division of Dermatology CTD No. 999999
Drug Products/HFD-500 BrainO (brainoxyin)
Office of Drug Evaluation II X-ray Vision
Attn: Document Control Room 10B-03
Center for Drug Evaluation and Research
5600 Fishers Lane
Rockville, Maryland 20857


ORIGINAL BLA or NDA
CTD No 999999
BrainO (brainoxyin)
BrainO Tech

Dear Dr. _________:
We are submitting this New Drug Application (00-1234) forBrainO for
the treatment and prevention of all skin diseases .

We are submitting this NDA in accordance with PDUFA Appendix E, for a new
indication while the original application is pending review. The size of the electronic
portion of this NDA submission is 735 MB on two CD-ROMs. The virus scanning
software used for this submission is Network Associates VirusScan version 4.0.3A
(formerly known as McAfee VirusScan).

The majority of NDA Items 2, 4 and 5 are cross-referenced, rendering the approval of
this NDA (12-3456) contingent on the approval of NDA 65-4321 In reply to the FDAs
request at the June 9, 2000 pre-NDA meeting, all patient case report forms (CRFs)
required for filing to 12-3456 are reproduced in hardcopy in this NDA, with the
exception of those required CRFs from patients in the clinical trials, whose CRFs are
provided electronically in NDA Item 12.
In addition, we will provide within 60 days of this NDA filing, patient profiles for the
pivotal trials (056 and 058) as described during the January 27, 2003 telephone
conference call with Dr. Image and Ms. Solutions of your Division.


If you have any questions concerning this submission, please contact me at (973) 292-
6444.

Sincerely,
xxxxxxxxxxxxx, PhD
Associate Director
Drug Regulatory Affairs