Image should not include company name, page no.

and arrow symbols

Entinostat: Interim OS analysis from P3 E2112 trial (NCT02115282) in combination with

exemestane for advanced HR+ breast cancer in Q4 2019

Non-prem drug should be in summary (in combinaton with non-prem drug)

Trial should be before NCTID

Indication should be in lowercase.. For Alzhiemers, Parkinson’s indications, we use initial capital

Use HR+

Entinostat: NDA submission for HR+ metastatic breast cancer in 2021

We donot write filing in summary.. Use submission
Only timeline after indication..Anticipated not req
Use HR+ in this form.. Non prem drug is not required in filing timeline, incase of clinical
milestones non-prem drug should be in summary before the indication

We do write Initiation of – Incase of trial initiation

Another set

Repotrectinib: Initiation of P2 portion of P1/2 TRIDENT-1 trial (NCT03093116) for ROS-1 positive
NSCLC and NTRK-positive solid tumors in H2 2019

Initiation of trial for pediatric advanced solid tumors in H2 2019

If we have data at any conferences in slide, pls do check the conference dates and mention in the
summary as below

Arrow symbol shouldnot be there in slide

Repotrectinib: Presentation of data from P1 portion of P1/2 TRIDENT-1 trial (NCT03093116) for ROS1
NSCLC at ASCO (May 31- June 4, 2019)

Interim data from P2 portion of P1/2 TRIDENT-1 trial (NCT03093116) for ROS1 NSCLC in H2 2020

3letter indication we can use abbreviated form, If the indication is new or not used much please
expand the indication in summary
Milciclib: Top line data from P2a trial (NCT03109886) in HCC in Q2 2019.
Sitravatinib: Initiation of P3 (NCT03906071) trial in second line NSCLC in H1 2019.

Trial before NCTID

Secondline – should be 2L

Sitravatinib + Nivolumab: Interim ORR analysis data from P3 trial (NCT03906071) for 2L NSCLC by
end of 2020

Primary OS data from P3 trial for 2L NSCLC by end of 2021

Sitravatinib + Opdivo: Initiation of P3 trial (NCT03906071) in patients with advanced non-squamous

NSCLC in H1 2019

Sitravatinib + Opdivo: Initial proof of concept data from P2 trial (NCT03606174) in urothelial cancer
in H2 2019

Sitravatinib + nivolumab: Initial mechanism of data from P2 trial (NCT03680521) for pre-surgical
clear cell renal cell carcinoma in H2 2019

Initial mechanism of action data from P1 SNOW trial (NCT03575598) in HNSCC in H2 2019

Pls check the summaries

In image we have sitravatinib + opdivo combination..So, we use both drugs as both are premium

Indoximod: Updated data from P1 trial (NCT02502708) in pediatric patients with front-line DIPG in
H2 2019

Completion of global P3 trial (NCT) for r/r AML

Vadadustat: Completion of P3 INNO2VATE trial (NCT02892149) for maintenance treatment of

anemia in DD-CKD in March 2020
Completion of P3 PRO2TECT trial (NCT02648347) for anemia in NDD-CKD in August 2020
Advancement means initiation of trial

Brexpiprazole: Advancement to P3 (Didn’t get NCT ID) trial in US and Europe in PTSD in FY 2019.
Rexulti: Initiation of P3 trial in US and EU for post traumatic stress disorder in 2019

Patents --- not patent

Can use Jan, Aug, Dec

From------ in

of---------for

CHS-1420: Launch for Psoriasis in July 2023 or later

PFS update, Os update

Completing UPMS we don’t cover; will complete or completion we should cover.

Ongoing UPMS we don’t cover

PDFUA date for approval of disease on sep 27, 2029

If NDA mentioned we take, otherwise we write as
Regulatory submission in US

Regulatory submissions in US, Europe and Japan etc

No need to mention as patient enrolment, Just write as Enrollment

Provide guidance means -------------company will update on initial analysis of trial.

Entries:

Should not mix regulatory and clinical milestones

Shouild the drug be mentioned in the SSF format in Title.

Patent expiry in US in 2029

Expiry of patents related to methods for making/folding gastroretentive drug delivery system in US
in 2028

Ensifentrine: One-week dosing data from P2 trial with DPI formulation for COPD in Q3 2019

Single dose data from P2 trial with MDI formulation for COPD in Q3 2019

One-week data from P2 trial with MDI formulation for COPD in early Q1 2020

LentiGlobin: Regulatory submission in US for transfusion-dependent β-Thalassemia by end of 2019

GCA: Giant cell arteritis

Tag enrolment status, if summary as enrolment until 2020

Regulatory submission in US------------------Tag NDA

Regulatory submission in EU------------------MAA Tag Europe Regulatory

Title:

URL:

Summary:

Trial ID:

Trial Name:

New source:

Topic Tag:

Product:

Area:

Above entries in Larvol