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DewDiligence

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DewDiligence

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Re: iwfal post# 44572

Sunday, 04/08/2007 11:33:08 AM

Sunday, April 08, 2007 11:33:08 AM

Post# of 257443
>it isn't clear what the FDA's ability to repeal Provenge will be if it doesn't get p<0.05 on the Phase IV? This appears to be a gray area? Better than a true Accelerated Approval. Less final than with no mandated phase IV.<

Or they could simply issue an approvable letter and request that a CU program be set up until the results of 9902b are known.

“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”

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