Biotech Values

[gofishmarko]

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 ?