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Biotech / Medical : InterMune (nasdaq)ITMN -- Ignore unavailable to you. Want to Upgrade?


To: Biomaven who wrote (467)2/3/2009 10:25:16 PM
From: DewDiligence_on_SI1 Recommendation  Respond to of 508
 
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.

Agreed—the FDA historically has not imposed a penalty for missed trials (although perhaps they ought to figure out a way to do this objectively). Hence, I’m inclined to agree that ITMN’s chances for eventual approval are very good even if they come up short on this review cycle.

As far as I know, the EMEA’s M.O. on this matter is similar to the FDA’s.