Good stuff coming out of this discussion, Flip. Got to wait a while for her reply. It is only 4:20 am in California. I am up because of my interest in the Australian Open. Need to go back to bed.
I think we can lay to rest the speculations regarding the 2015 trial halt.
Yesterday. My response post to ex was initially going to be about the DMC having been unblinded every meeting they had (amongst each other) as us specified in the protocol; and that they may have suggested to management that the trial be halted due to issues we now know to be pseudoprogression… and I was using the command F tool to lookup “DMC” on the protocol (I don’t think I’d looked at the protocol in over a year). So when I read the text I cited earlier about requiring an SAP on hand in order to down IA; and knowing there never was an earlier SAP… I knew for certain, then, that no efficacy interim analysis could have ever been done.
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