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Post# of 252484
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Alias Born 04/28/2004

Re: DewDiligence post# 4554

Thursday, 11/04/2004 1:23:06 PM

Thursday, November 04, 2004 1:23:06 PM

Post# of 252484
I agree and I definitely painted with a wide brush there. I think it was one of the FDA transcripts with Bob Temple that influenced me. He waxed on and on about considerations for non-inferiority trials that made my head spin, especially when he started quoting patients numbers of about 1000 for appropriate trials.

I also think that it places a difficult marketing burden on a small biotech when they have to go out and compete with Lilly / Aventis et al based on non-inferiority rather than superiority.

fwiw...

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