My point is that halting recruitment, not the trial, but recruitment (new screening), seems to be the thread in this trial, because that is what you are suppose to do if the evidence is sufficient to reach a conclusion. Not that it had sufficiently yet reached that conclusion, but that it had evidence sufficient to reach that conclusion. Fraunhofer's statement that 331 (perhaps 300) recruitment is all that is statistically necessary for the study, means recruiting more would be unethical. Your point is certainly valid that Fraunhofer seem to attribute the early recruitment freeze to their manufacturing and testing efforts as well. It's a good additional point.
Particularly when the Germans, like UCLA, were able to develop independent assays showing why/how/when/by how much the immune system was boosted with DC therapy and not by SOC alone.
I mean, let's think about it. What they were likely seeing is that people that had immune responses -- meaning exponential CTL multiplication, reduction of T-regs, etc -- were living longer and the others weren't, at some point it is simply unethical to keep placing people on a placebo arm where you know they will have no immune improvement, 97% (historically) will not have a chance to beat GBM long term, and you know this without a doubt (hypothetically) because you know the immune responders to vaccination are being provided an immune boost and the chance to beat GBM or at least live considerably longer. They are also likely seeing what they learned earlier, that vaccination of progressing tumors without second surgery is far less likely to give crossovers any significant boost -- although probably more than peptide vaccines did.
Whether they had IAs or not, it would be obvious to the researchers looking at immune response and survival.
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