Replies to post #182709 on Biotech Values

[DewDiligence]

Clinical / Regulatory / Litigation Calendar

[Please keep these entries up to date! See
the updating procedure at the end of this post.
Items that are out of date will be removed.]

NOTE: ANYONE MAY UPDATE THIS FILE


Edits: ABBV/ENTA, CNAT, GILD, MCRX, MRK, OCRX, XOMA.


ABBV/ENTA—Viekira (w/o ABT-333) NDA submission in Japan for GT2/GT1b: 1H15.
ABBV/ENTA—ABT-493/ABT-530 pan-genotypic regimen: ph2b data 2H15.

CNAT—Ph2 data from four trials: NAFLD/NASH 1Q15; post-HCV-transplant 2Q15; portal hypertension 3Q15; general cirrhosis 4Q15.

GILD—Harvoni approvals in Japan for GT2/GT1b expected 2H15 (separate submissions made in June2015 & Sep2014, respectively).
GILD—Ph2 data from 3-DAA HCV regimen (Sovaldi + GS-5816 + GS-8857) w 4-6-week durations: interim data at EASL Apr 2015; final data 2H15.
GILD—Ph3 data for Sovaldi + GS-5816: 4Q15.

MCRX—Data from 1st ph3 in foot ulcers: mid 2015.

MRK—NDA submission of 2-DAA HCV regimen (PI+ NS5A) 1H15.

OCRX—Ph2b in HE: futility/size test 1H15; final data late 2015 (maybe).

XOMA—EYEGUARD-B ph3 in Behçet’s uveitis: top-line data soon (was expected 2014).

--
Procedure for Updating Calendar

When adding or modifying entries, please follow these steps:

1. Copy the complete text from the old calendar.

2. Make your additions or modifications, inserting new items in alphabetical order.

3. Near the top of the message, list the ticker symbols of the entries you changed (e.g. “Edits: GILD MNTA”).

[DewDiligence]

Clinical / Regulatory / Litigation Calendar

[Please keep these entries up to date! See
the updating procedure at the end of this post.
Items that are out of date will be removed.]

NOTE: ANYONE MAY UPDATE THIS FILE


Edits: ABBV/ENTA, CNAT, GILD, MCUR, MRK, OCRX, XOMA.


ABBV/ENTA—Viekira (w/o ABT-333) NDA submission in Japan for GT2/GT1b: 1H15.
ABBV/ENTA—ABT-493/ABT-530 pan-genotypic regimen: ph2b data 2H15.

CNAT—Ph2 data from four trials: NAFLD/NASH 1Q15; post-HCV-transplant 2Q15; portal hypertension 3Q15; general cirrhosis 4Q15.

GILD—Harvoni approvals in Japan for GT2/GT1b expected 2H15 (separate submissions made in June2015 & Sep2014, respectively).
GILD—Ph2 data from 3-DAA HCV regimen (Sovaldi + GS-5816 + GS-8857) w 4-6-week durations: interim data at EASL Apr 2015; final data 2H15.
GILD—Ph3 data for Sovaldi + GS-5816: 4Q15.

MCUR—Final data from 1st ph3 & interim data from 2nd ph3 2H15.

MRK—NDA submission of 2-DAA HCV regimen (PI+ NS5A) 1H15.

OCRX—Ph2b in HE: futility/size test 1H15; final data late 2015 (maybe).

XOMA—EYEGUARD-B ph3 in Behçet’s uveitis: top-line data soon (was expected 2014).

--
Procedure for Updating Calendar

When adding or modifying entries, please follow these steps:

1. Copy the complete text from the old calendar.

2. Make your additions or modifications, inserting new items in alphabetical order.

3. Near the top of the message, list the ticker symbols of the entries you changed (e.g. “Edits: ENTA GILD”).