Getting tired of reposting this but people seem to have amnesia
Dr. Liau Verbatim (2 and a half minutes of the exact verbatim quote from her video) where she explains why the FDA insisted on it:
19:03
We restarted the trial again in 2010 as a phase-2. Got some good initial data and went on to currently a phase-3 trial. This time its blinded, randomized and controlled. So now we are making vaccine for everybody ahhh and that was a way to retain the patients on the trial. The caveat here, then though so now the blinded trial, is comparing these are all newly diagnosed glioblastoma patients and patients either get standard treatment plus vaccine or standard treatment alone and plus placebo. We actually give them just PVMCs as placebo, but the issue is because we have vaccine made for everyone and we are kind of doing a somewhat invasive procedure on these patients the FDA actually required us to have a cross over arm so we have a crossover arm when patients progress. So interestingly the whole cohort actually has not yet reached I guess its yes predetermined event, umm ay yay how would you say it the predetermined number of events and it seems like everyone is living longer than we would have been expecting so in reality I think what we are really comparing now is early DC vaccination vs later DC vaccination and and I guess it is a good thing patients are living longer but it is not really helping our study because if the patents didn't get anything hopefully the differences would be bigger . . .
20:40
