The high crossover rate is not unblinded data. Of course they know how many patients are IN the trial and will be control arm or not. They are not required to be so blind that they have no idea what they are doing in any possible way. That would be absurd.
There is no “new science of pspd” pseudoprogression, it was simply a fact discovered during the course of such drugs being used in people. This was one of the first immunotherapies in GBM in terms of the start of the trial and took a long time also because of the financial crisis and lack of funds. So it was discovered only after the trial started and NO, it is not subject to question or criticism. It is well known and widely believed. That is why there are new standards for PFS, because of PSPD, one that is already considered flawed and another that is not thought to be perfect either. This is not some made up theory and no, it will not be met with skepticism. It’s a fact.
Pseudoprogression and pseudoresponse are so well known that PFS is not a real endpoint and only a surrogate endpoint for most clinical trials, the key issue being does it correlate to increased OS. When you then prove increased OS, despite an uncertainty about recurrence decisions, which were subjective, then the correlation was never there for recurrence determinations under that older standard of measure, because of pseudo-recurrence, which is exactly what happened here.
This is why they evolved the PFS + 6 months standard, giving more time. That is one of very many secondary measures on the combination therapy trial. But it is not primary and many of the measures are biomarker measures as the company appears to be looking for a variety of ways to correlate some more rapid to determine measure with increased OS, so that they do not need to spend 10 years accruing data before they can prove efficacy.
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