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flipper44

01/06/26 6:03 PM

#807629 RE: manibiotech #807628

I’m not certain you understand what it’s saying, but if LP accepted (hypothetical) approval conditions on the 29th, the MHRA would need to validate and grant (by? Or) before January 15th (about four days faster than usual?) to beat the European IT changeover, otherwise months(?) of conversion headaches?

The validation goes over stuff like Summary of Product Characteristics.

I would note, Linda stated there’s more than one company’s MAA where they are at right now (two years from maa submission). It could be they are all trying to wrap things up on or before January 15. I don’t know. Perhaps this is why the MHRA is devoting so many resources to NWBO recently according to LP.