I do have to laugh about longs calling you a basher for not being reasonably certain of approval within 150 days.
Anyway, on the core subject, I doubt any novel agent has received an EU/UK approval w/o an RFI and clock stop. In EU the first clock stop is now mandatory.
And the complexity of -L would be off the scale. Consider 2 sources of issues to be ironed out.
1) What is the rGBM label? The trial used -L immediately after progression. But that required -L to have been already manufactured subsequent to nGBM. But if manufactured then, would it not have been used then? How exactly would one write this label?
2) Manufacturing. As a rule, biolologics are approved using the manufacturing as established in the P3 trial(s). But these long since have ceased to exist, They now have a new mfg facility. That the facility is approved does not mean that it has been established to follow the same process to manufacture -L. Yes, they have put together a plan to establish this, but such are often bones of contention.
And these to not even take into account the elephant in the china shop issues of the trial and switch to ECAs.
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