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gofishmarko

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gofishmarko

Re: None

Thursday, 05/10/2007 12:51:22 AM

Thursday, May 10, 2007 12:51:22 AM

Post# of 253120
Re : DNDN

I just wish the FDA would provide some quantitative summary of the DNDN efficacy data package , as a basis for comparison to other BLAs and NDAs. Shouldn't they be able to look at any submission and come up with an all-encompassing , single numerical estimate of the probability of Type 1 error for efficacy ? If they can , what is that number for Provenge , so far , and what does it have to be post-02B analysis ?
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