Biotech Values

[DewDiligence]

Re: The changing efficacy metrics on HCV

Following up on the discussion in #msg-68709472, I see in today’s PR from Medivir that the FDA agreed to change the primary endpoint from SVR24 to SVR12 in the phase-3 trials for TMC435:

http://finance.yahoo.com/news/Medivir-Key-News-Ongoing-bw-1350933955.html?x=0&l=1

SVR12 - new endpoint

In the ongoing phase III studies in naïve and patients that have relapsed following previous treatment, the primary endpoint has been changed from SVR24 to SVR12 following recent discussions with the FDA. These studies (QUEST 1 &2 and PROMISE) were all fully recruited in August.

This is a pretty big deal, IMO.