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iwasadiver

03/31/21 10:49 PM

#366159 RE: HappyLibrarian #366155

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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X Master

03/31/21 10:56 PM

#366164 RE: HappyLibrarian #366155

First of all, I must believe the FDA wants to move the ball down the field with GBM. Second, I believe potus will carry the ball to the goal line like the refrigerator. I’m confident he will roll some heads given the cause.