Replies to post #188743 on Biotech Values

[DewDiligence]

MCUR—The clinical-trial change for the VLU phase-3 trial in the previous post is that there will no longer be an interim analysis for efficacy, but rather a futility analysis that will consume no alpha.

[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Items that are out of date will be removed.]

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Edits: CNAT (phase-2 NAFLD data already out—item removed); GILD (Sovaldi approved in Japan for GT2 patients—item removed).


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: futility/size test in early April; complete enrollment end 2015; final data 2016.

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).

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