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Re: biomanbaba post# 2

Saturday, 01/29/2005 12:03:18 PM

Saturday, January 29, 2005 12:03:18 PM

Post# of 208
MY concern with Introgen is simple.

Survival data is the strongest type of data for cancer trials. INGN has a phase III that measured survival.

If the phase III was successful in improving survival, surely they would use it as the pivotal trial and not go through the accelerated approval route using surrogates of survival. If the phase III wasn't successful and they're trying to apply based on surrogates, won't the FDA see that their surrogate endpoints were not validated by improved survival?

I read, but initially did not believe, a post on yahoo about the company having over 1 PR per week over the last year. So I checked up on it and it's true... that's a lot of publicity for a scant amount of data. A bit of a red flag for me as well.
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