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steveporsche

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steveporsche

Re: None

Wednesday, 01/21/2009 5:50:21 PM

Wednesday, January 21, 2009 5:50:21 PM

Post# of 252233
Question for the Board

Can anyone name an instance where the FDA approved a drug application based on two Phase III near misses on p-value on primary endpoint? Such an application would need to be for a life-threatening disease and the drug was not already approved for another indication.

Thanks
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