Your constant posting of quotes and presentations is also in the lawsuit, yet those events did not happen. Speculating time and time again that eventually they must have is futile. Plus, what is to say if they had done an efficacy review, the partial halt would not have been lifted, if it was for some other reason, together with a completely transparent discussion of pseudoprogression that would have almost certainly have occurred. Yet they did not do it. No, there was no safety issue for DCVax, for treated patients, the safety issue was for the placebo as a group, hence they stopped apparently enrolling the anticipated new and larger number and the end result is that deduction came out of the placebo count. In other words, the difference became patently obvious for the groups, no need to look at the specifics or drill down to efficacy. There was a patently obvious impact from DCVax. That’s my opinion.
You do not know what you assert is true, and the case established that clearly. No one knows. They wanted to do that analysis, but again, it may have become patently obvious to everyone that patients had to be doing well. What we do know is they did 1) review for safety only, and then at some point 2) they did a blinded review for the paper. That is what we know occurred.
I would argue that the partial halt likely came as a result of that safety review, and was likely discussed by the regulators in the context of noting that placebo patients it was obvious, without having proof of efficacy, because that was not possible at that moment because of all of the crossovers, etc., it was patently obvious that placebo patients were doing badly from a safety review by the DSMB.
It is possible that to a pedestrian observer, the safety review looks and sounds like efficacy but it is not.
