Replies to post #72630 on Biotech Values

[DewDiligence]

ITMN – One thing we can say for sure is that the FDA advisory panel won’t be dull!

Would’ve been a good short at 18+ in the pre-market.

[DewDiligence]

ITMN – Here’s a technical error by Adam Feuerstein (the kind of error he makes quite often):

http://www.thestreet.com/print/story/10461565.html

On its conference call Tuesday, InterMune executives spent a lot of time discussing various analyses of the phase III studies, both individually and pooled, to make the case that IPF patients were benefiting from pirfenidone treatment. Some of these cuts at the data were prospectively laid out in the studies' statistical analysis plan, but others were what the company deemed "exploratory," which means they were done after the data had been collected and, as such, may not carry as much weight with regulators in the U.S. and Europe.

No, Adam. The secondary endpoints were deemed to be exploratory not because they were post hoc, but rather because the primary endpoint was not hit in both studies. This is a standard tenet of biostatistics when the secondary endpoints from two trials were designed to be pooled, as was the case with pirfenidone.

If you don’t know what you’re talking about, ask someone who does before you go to press.