thurly, your interpretation of the company's vision of early FDA approval seems about right. You said, "I would not be surprised if we missed stat[istical] sig[nificance] for some reason that was not clear from the earlier work."
In some ways PPHM DID miss statistical significance, by reporting data that was only good at the 05% confidence level. Any number less than that is a wasted trial. So we can say the India venture paid off handsomely. Huge! After the numbers are in, statisticians take over to determine the statistical significance of the generated numbers, and their formulae will push the confidence level as high as the numbers will permit. An order of magnitude greater than .05 would definitely do it. So would .01%. But .05% was it. No higher level of significanc was possible from that set of data. That's what they had to go public with. That's what we live with. 05% is acceptable evidence for me because I am gambling here, but it is not acceptable to the hardened realists at FDA (and BP and Wall St.).
A repeat of that number (or better) under US testing and reporting conditions would probably do it. Most important, overall survival number is not in, and as CJ and others have observed here, the longer that information takes to generate, the better it looks unless the number is known already and not divulged. If that number is spectacular the other numbers won't matter.
As mentioned here before, the DNDN denouement was actually good for PPHM because if DNDN can get Provenge approved on the piddling numbers they came up with, PPHM can get Bavi through on its results, India or no.
