Very hard to say what the regs have said or not, or exactly where we are.
It is very clearly the case that NWBO doubted whether the FDA would find these data approvable. All talk about MHRA moving faster is sidestepping the facts: the FDA was not going to approve based on this phase 3 trial, not without some kind of clear correlate that the drug is doing something (as opposed to happening to recruit an unusually lucky pool of ~200 patients who happened to have a 5% improvement in the landmark OS rate).
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