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Re: BTH post# 102719

Friday, 08/27/2010 1:30:41 PM

Friday, August 27, 2010 1:30:41 PM

Post# of 257271

they delay (like Provenge which showed clear evidence of efficacy).



I am a big suporter of Provenge. However, to say it had clear evidece of efficacy in original BLA is a stretch. Remember, it failed its primary endpoint. The efficacy you stated was from post hoc analysis. FDA should NEVER approve a drug from a study that failed its primary endpoint. They need to run a better trial. They did, and it got approved.

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