Monday, October 16, 2017 8:48:21 AM
And it is that interim, the one expected in the summer of 2015 (coincident with the FDA clinical hold) where I am suggesting futility was observed on PFS.
Avii, how did the FDA find out about this futility result on the 2nd IA if the co never released it and kept it secret according to you? So why the hold again? I am not familiar with the broad history of futility recommendations in the past, but I strongly suspect that they did not always get a hold response from the FDA if the co decided to continue with the trial.
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