If the women didn't benefit at all, then the response rate on men must have been 32%, this assuming that half the paitients were men and half women. When you take out over 65, then the men under 65 must have had even higher response rate than even 32%. Any thoughts on this? The results of the trials were known some time ago, to sell out at last minuite due weak stomach makes no sense. Rooster
Sorry to bust your bubble, but 75% of the patients in the study were male and the genasense arm had a 20% response rate. Of course ODAC is unlikely to care about retrospectively designed sub-group analysis. To get approved on a single, open-label, phase III trial, you need consistency across multiple endpoints and highly significant p values, GNTA has none of these.
It just ain't there folks, any objective person can see it. This will be very ugly.