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Items that are out of date will be removed.]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: OCRX.
ABBV/ENTA—ABT-493/ABT-530 pan-genotypic regimen: ph2b data 2H15.
CNAT—Ph2 data from three trials: post-HCV-transplant 2Q15; portal hypertension 3Q15; general cirrhosis 4Q15.
GILD—Harvoni approval in Japan (for GT1) 2H15. (Sovaldi already approved in Japan for GT2.)
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.
GILD—TAF PDUFA date 11/5/15.
MCUR—DFU ph3: final data Oct 2015; VLU ph3: futility test (HR ranges) 2H15, final data 1H16. BLA submission (incl data from both trials) 2H16.
MRK—NDA submission of 2-DAA HCV regimen (PI+ NS5A) 1H15.
OCRX—Ph2b in HE: complete trial (now upsized to 230 patients) 2H16.
RVNC—Phase2 data for RT002 vs Botox in glabellar lines: late 2015.
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”).
“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”
