I want NWBO to succeed and am all for NWBO being able to change their SAP. Not trying to argue, but they clearly had some SAP in mind at the trial outset. That analytic approach would determine the parameters for their power analysis and sample size determination. A company investing so much money in a trial without thought in advance to how the data would be analyzed would just be incredibly sloppy (and hopefully not the case for NWBO). Companies I have worked with for FDA trial design all had a statistician working on the team and had a clear analytic plan before the trial started (and discussed the plan with the FDA). Maybe this is semantics - was the analytic plan they developed ever formalized as a "SAP" they were locked into with the FDA? I don't know.
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