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Re: HappyLibrarian post# 366155

Wednesday, 03/31/2021 10:49:46 PM

Wednesday, March 31, 2021 10:49:46 PM

Post# of 828524
Maybe I missed something here. Are you saying because we are now, with the new endpoints and SAP, going to compare to historical controls it’s no longer a “Gold Standard” trial? I don’t think that’s going to be any issue at all. The FDA is the one who put out the guidance that allowed NWBO to do this. The trial is still going to compare internal treatment vs. internal placebo, it’s just going to be adjunct evidence in my opinion. And if it’s consistent with what’s being seen, even with the crossover, this is going to be such news that the pressure will be immense from patients and patient advocacy groups. And Biden being President, and who’s son and good friend and colleague both died of Glios, I don’t think there’s a need to be too worried about the FDA
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