Saturday, February 06, 2016 11:53:19 AM
I agree with your opinion that the company and investigators are not blinded to much of the trial. I will go ahead and speculate that whatever the reason for re-sizing the trial and PFS threshold, it had something to do with their ability to analyze certain trial data. I'll leave it at that.
The possible "problem" with the pseudos is that they might be contributing to events when in reality their progression isn't valid and shouldn't be counted. Why would this be any more of a safety concern than true progression? I don't believe it would be. Both would be marked as an event and the patients crossed over. There wouldn't be any safety concerns flagged by these events.
The prior DMC review had nothing to do with efficacy. The 1st IA (which likely occurred last summer) was the first opportunity for an in depth review of efficacy. The trial was halted by NWBO shortly thereafter. My opinion, as idiotic as it may seem, is that the trial complications were identified at the 1st IA.
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