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I think the prevailing negative perspective on the

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iwasadiver Member Level  Tuesday, 11/12/19 09:14:24 PM
Re: exwannabe post# 251210
Post # of 254699 
I think the prevailing negative perspective on the trial, that began when there was no interim efficacy analysis, is over thought. I think what happened is that Germany started doing something different and outside of what the FDA, a much more stodgy enterprise (good or bad), was comfortable with allowing in the US. I think the FDA put the hold on to prevent whatever was happening in Germany to happen in the US portion of the trial. I even think it may come out to have been a really absurd thing in the final analysis of what happened, and that’s why NWBO implied the hold might actually turn out to be a good thing. Given that, NWBO voluntarily put the same hold on Europe to prevent any complaints of unfair advantage to European trial participants over US ones. I think it had absolutely nothing to do with PFS, although that is what emerged as the popular theory about a failed trial.

Even though PFS may have been a difficult issue I think the final results will show that the long survivors indeed had the expected long PFS. How the SAP shows who did what, what tumor characteristics benefitted most, etc. is most likely a highly educated and much thought out guess, which is part of my life in the ER daily; hunches, experience, gestalt, etc. actually tend to be good predictors in actual practice even if that idea is poo poo’d by those not in the game.

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