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Re: DewDiligence post# 122443

Monday, 06/27/2011 6:16:46 PM

Monday, June 27, 2011 6:16:46 PM

Post# of 257375
Here's the text of where he tries to interject at the meeting:

http://www.google.com/url?sa=t&source=web&cd=2&ved=0CCUQFjAB&url=http%3A%2F%2Fwww.fda.gov%2Fohrms%2Fdockets%2Fac%2F07%2Ftranscripts%2F2007-4301t1-Errata-Part4-Page-299-to-303.pdf&ei=RP8ITvLZLc7TgQe7loG8DQ&usg=AFQjCNG-hO6Sq3h1f6AKcYYpBP3GWPU5Bg&sig2=rE-Mqg1hKkY6_pzCAe1HPw

In that transcript he claims to "work with the University of Michigan" and his beef seems to be some sort of accusation of conflict of interest. So does that cast doubt on whether this is in fact the right Kanzer?

(I've always wondered if that the rejection was the FDA statisticians being pig-headed. Missed the primary endpoint at 40 days, but hit it at 80 days and had a mortality benefit to boot. But the FDA did say there was some sort of imbalance between the arms, so maybe I don't have the full story).

Peter

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