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Biotech / Medical : InterMune (nasdaq)ITMN

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To: DewDiligence_on_SI who wrote (466)2/3/2009 9:35:53 PM
From: Biomaven1 Recommendation  Read Replies (1) of 508
 
>>much stronger placebo effect than IPF

Granted, but in both cases you are dealing with heterogeneous diseases with variable courses (over the length of a trial at least) and with some variability in endpoint measurement. (Of course depression trials are much larger which helps offset the placebo effect). Thus in both cases "stuff happens" that causes some trials to fail even though the drug might actually work.

But my main point was that ultimately the FDA doesn't seem to hold unsuccessful trials against you if you can come up with two successful trials. Here they have one successful trial and perhaps the Shinogi trial if the FDA will accept that, and certainly the potential for another successful trial at some point if the FDA turns them down now.

Peter
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