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theorysuit

12/15/25 6:23 AM

#802945 RE: Survivor2012 #802938

The FDA directed NWBO to change the primary endpoint from Progression Free Survival (a statistical extrapolation) to Overall Survival (The gold standard for survival, i.e., patients are actually still alive).



The fda did not direct nwbo to do this. In fact. Nwbo shockingly never revealed meeting notes with the fda. . So Don't make up BS. No RA would recommend shifting endpoints when the primary failed miserably. What nwbo did in this trial is straight up BS no one ever does......blasphemy....what they should have done was REVEAL the results of post FDA meeting minutes and posted the original results which they have to date NEVER done and designed a proper trial with OS. What they did was create a laughingstock of trial and tried to justify it with this gold standard OS and Jama to try and explain/justify this madness. Run a new trial....plain and simple. Stop trying to feed thsi same company excuse.....jama, os gold standard and fda said so BS for this blasphemy NWBO is trying. It is going to fail and I'll be the first to tell you I told you so.

Total scam of company. 100 % scam. Even worse that cvm.