As long as people are guessing at what the FDA said, I'll guess that the FDA said that far greater production was needed than could be produced with 20 tiny cleanrooms at Sawston. Show us real commercial production when you have it.
Nope. If NWBO used actual patient level data then the comp will be to those patients who match the -L P3 inclusion criterion, not all patients.
Did you not see that in patients with MRD (same as near total resection) the ECA had a MOS of 20.4 months? Given that -L required "intent for near total resection" that would be a closer comp than including biopsies and partials.
More importantly, the RAs can perform a proper analysis only if they have actual data. The idea of trying to read a KM plot and recreating the real data is funny.
It's NOT supposition -- it is the evidence based on 20+ years of biopharma experience and investment. If a biotech doesn't file with the FDA, it's ONLY because the FDA said they didn't have enough clinical evidence for FDA to accept the application.
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