p3analyze:
Assuming, as I will, that your statistics are accurate wrt stopping at 98 deaths in the TAX 327 docetaxel trial yielding a calculated p value of 0.20, IMO, that statement would have stopped Hussein and Scher cold at the Advisory Committee meeting, especially if DNDN would have followed up with a Petrylak type analyis of how powerful the combination of Provenge and docetaxel are. The argument would have gone over to trial numbers then, but your statement regarding what would have been a comparison to the standard of care, IMO, would have made a strong impression.
Unfortunately, as you know, IMO, the failed February preapproval manufacturing inspection would ultimately have produced the same result. The results of DNDN's Motion to Dismiss are still not known in the court case. If DNDN loses, discovery should provide a definitive answer to my belief; if not, no one but some at the FDA and a few insiders will ever know for sure. JMHO.