PFS and OS are two of the 6 endpoints that the FDA will accept for approval consideration.
The trial was designed for PFS and the crossover was the rescue medication, that all oncology trials require. DCVax-L offered crossover after disease progression. From clinicaltrials.gov trial posting: "All patients will have the option to receive DCVax-L in a crossover arm upon documented disease progression." That's when the patient progressed.
Statisitical analysis in many cases can't account for confounding. NWBO stated naive OS was confounded but there was NO statistics to account for the confounding. That's why the naïve OS endpoint is questionable no way to account for the confounding.
Doubt the trial will have an advisory committee. FDA may very likely not accept the application due to all the protocol manipulations.
Also PIP is only usable for MHRA, not FDA. FDA doesn't care about Pediatric trials. Having a PIP trial plan has nothing to do with the evaluation of an adult clinical trial that has already been completed.
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