Biotech Values

[DewDiligence]

>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?<

9902a had an overall-survival HR of 0.79 using the conventional rather than reciprocal way of expressing the metric, which is of course quite good. But the raw p-value was 0.33, which is not good. The totality of the 9902a data does not meet my definition of supportive.

p.s. I’m posting this as a reply to your request in #1141 on the DNDN board.