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Re: iwfal post# 2323

Tuesday, 03/27/2007 11:59:30 AM

Tuesday, March 27, 2007 11:59:30 AM

Post# of 12660
Basically then it boils down to one trial with unimpeachable Significance and a smaller one with an unimpeachable Trend.

And the smaller one seems to have some population bias.

Substantial Evidence for Clinical Benefit ? I think Yes on balance.

Ergo .............. I think we will enjoy both the Dance and the Party too.


One Caveat - the Questions - the Votes are almost a footnote; I would say the FDA is reserving its Rights if the vote can be termed inconclusive at all. But what's on their mind ?


"....on the biotech battle-field, you need some élan...."

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