To be very clear. An elevated OS in the control group that uses live DC's unexposed to antigen means that the therapy is not getting a fair test. It means that the DC therapies are better than these tests are indicating. It means some number should be agreed upon for reduction of the efficacy difference bar for approval.
Good evidence of such an elevation of the control group would very likely sway the Europeans, who are capable of non-linear thinking, in my opionion. Not sure it would sway the FDA, but if not, then certainly a topic worthy of public debate.
But that is way ahead... not sure how much of an effect this was on the control group for IMUC, and don't know that NWBO used the same type of placebo. But they probably did, and they are probably seeing the same effect on control group OS. And that issue is probably in debate right now.
But maybe I am not giving the FDA enough credit. There is supposedly a new attitude. Let's hope that is real, and that, "You didn't say "Mother May I"" is not a legitimate argument to fail a clinical trial for a treatment for Brain Cancer.
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