before somebody else steps in to correct me.. I would like to clarify my post - as I have incorrectly merged two data sets in my post, which should be looked at separately.
So to clarify ...
The primary end-point for the phase III trial is response at 28 days which using the expanded access program + phase 2 placebo controlled trial data (in combination) met the primary endpoint with a p-value of 0.0014, that is 99.86% confidence.
The 82% vs 39% result (with p=0.0001) was the 100 day survival rate when comparing responders vs non-responders, which is actually a secondary endpoint in the phase III trial.
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