steve ..............
<<<<<"My desire was to bring up a quote I found by an FDA reviewer said cox should not be considered a substitute for a failed log rank.">>>>>>
Two things:
if 9902a had hit survival by log-rank, would there even be a Panel ? I don't think so - by the standards the FDA has previously used, the BLA would have been submitted earlier and provenge would be on the market by now.
also, you are applying a standard for a pivotal trial to what is instead a supporting trial - i dont know the words off by heart, but the FDA describes the single-trial paradigm was one with an extremely good trial supported by "other data" or vague words to that effect.
"....on the biotech battle-field, you need some élan...."
