Biotech Values

[mcbio]

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:

finance.yahoo.com/news/Medivir-Key-News-Ongoing-bw-1350933955.html?x=0&l=1
Quote:
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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.
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This is a pretty big deal, IMO.

Was this brought on at Medivir's request or mandated by the FDA itself? If it's the former, presumably a big deal in a positive way in that it speaks volumes to Medivir's confidence in TMC435? If it's the latter, possibly a big deal in a negative way in that this is a higher hurdle to pass?

Separately, regarding the news of the discontinuation of Medivir's nuke today (#msg-69011104 ), I'm surprised to find out that the nuke in question was apparently a nucleoside. I don't think we knew this before today. Note that today's PR also discloses that Medivir apparently has a nucleotide at the pre-clinical stage (in addition to their prior disclosure that they also have an earlier stage NS5A program).

I see that Medivir closed down over 8% today on the Stockholm Exchange (the ADRs didn't trade but I saw the Ask down below $9.50). All told, what is your reaction with respect to Medivir's shares after today's two news items? Frankly, after how beat up the shares had already been, I'm surprised they're off a good degree after today's news. I don't think the change in the Phase 3 TMC435 design is negative news. And while I understand a negative reaction to the fact that the nuke is being discontinued, it's probably not surprising given that it was a nucleoside. With a nucleotide at the pre-clinical stage, and the fact that the nucleoside was only in Phase 1b itself, I don't view this event as terribly damaging to Medivir. The key to the Medivir story is still TMC435 IMO and while people may question the ability of Medivir/JNJ now having their own in-house HCV cocktail with the setback in the nuke program, there is still the potential to combine TMC435 with PSI-7977 (that trial is supposed to begin shortly) along with the potential still being there down the road to combine TMC435 with the follow-on in-house nucleotide.