The HR is not nearly as good in 9902A as it was in 9901, but if you flip the numerator and denominator and measure it the same way as most biopharmas do, you get an HR of 0.77, which represents a 23% lowering of the risk of death. For a 98-patient trial, I'm betting that the FDA sees this result as sufficiently supportive for approval, especially with Provenge's very mild toxicity profile.
As for 9901, off the top of my head DNDN measured the HR as 1.7, or 0.59 as most companies measure it. So the question is, how will CBER view a BLA which had the primary Phase III come back with an HR of 0.59 and the supportive Phase III with a score of 0.77, plus a very mild toxicity profile, plus the fact it's for a terminal oncology indication?
We already know how much the prespecified, secondary Cox regression analysis improved the HR and the p value in both trials.
