froggmister,
AVII77 believes that his numbers point to selection process and not treatment effect. The problem is that mOS does not demonstrate late term separation which I believe actual data can and will. The other issue is that some effect, like for example up to 2 months added to OS from crossover plus salvage therapy will now be accounted for. The real victory here ,though, is that methylated mesenchymal, a very aggressive subtype not specifically tested for, might actually demonstrate a high cure rate and that others are receiving various degrees of benefit beyond that. Then there is the ancillary evidence from outside this trial that benefit can be increased by combos with ICLC and others and potential evidence that an “optimized” vaccine in the second half is producing improved results even though played down by some key folks. When a key clinician says he wants this treatment for all of his patients and AVII77 ignores this I wonder if his learning has biased him against the impact of patient advocates and the totality of evidence. I do not doubt that he feels he has good reasons to believe his position is based on a solid understanding of the patient selection process. I do believe, though, that late separation, adjudication of PFS, biomarker correlations to treatment benefit and patient advocate support at a minimum will make this approvable. I also believe the evidence will be better than this but that is gravy. Best wishes.
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