Replies to post #122443 on Biotech Values

[Zarathos]

I mean, is this really Steve Kanzer at the 2007 advisory committee?

I'm just hearing this story for the first time. Hard to believe that's really Kanzer being escorted out. Hilarious if it is...

[biomaven0]

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