I think mhra guidance is unnecessarily vague.
That said, I think if it’s valid without correction, it’s considered valid on receipt — as AI stated, but I’m too tired to go back and show why that’s not inconsistent with some uk.gov language.
That said, I believe the UK was late starting their evaluation clock. I believe it started January 24, 2024, after the MHRA belatedly (through no fault of NWBO) concluded the maa “passed validation.”
The “confirmation” of validation, on March 7, 2024, is not an event which causes delay in an earlier 150 day clock initiation according to ChatGPT. In other words, MHRA can walk and chew gum at the same time.
The late June timeline for the ASM is consistent with a 150 day clock that started on January 24, 2024 and ends late June, without any RFI apparently needed. This final paragraph I write is most speculative, but logical. Who would hold an ASM 1 to 60 days before a decision? Not me. Therefore, no RFI was likely requested, and the regulators will make their decision based upon an MAA that was perfectly edited at the time of submission. Seemingly a good sign for MHRA’s final decision. (As a side note, I believe NICE will have an appraisal decision ready by late June)
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