Monday, January 03, 2022 3:10:22 PM
The control arm crossed over on direction by the FDA because the treatment worked and its a lethal disease.
That's not how trials work. If the treatment worked per the DMC during the IA, the DMC would have recommended the trial be halted for efficacy, the company would have unblinded and submitted a BLA (back in 2016).
There is no harm in the patients crossing over from the control arm placebo to the treatment arm placebo (DCVax) because it does nothing.
One has to be an incredible dirtbag to keep patients in the control arm and have them die
One has to be an incredible dirtbag to avoid submitting a BLA and sitting on a cure for GBM for an extra year plus while patients are dying every day just to synchronize TLD release with a journal publication.
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