You’re actually proving my point with your own MHRA link.
MHRA clearly states that, as part of a marketing authorisation application, they perform product-related inspections of the actual manufacturing facilities and processes that will be used commercially. That means the intended commercial manufacturing process must be within the scope of the MAA/CMC review.
If NWBO’s long-term commercial process were truly “manual Grade B”, then yes that process is already licensed, inspected and validated for Specials, and MHRA could in theory sign off the MA based on that.
But NWBO’s own PRs now describe Flaskworks/Grade C as central to commercial scale-up. Once you tell MHRA “this is our intended commercial process”, that becomes the process they have to review and validate as part of the MAA. You can’t point MHRA to one process in the dossier and then commercially switch to another immediately after approval without a CMC update.
So we actually agree on the regulatory principle:
– The manufacturing process needs to be validated as part of the MAA.
– MHRA inspects the real, intended commercial configuration (sites, cleanrooms, equipment, QMS).
Where we differ is that you pretend this only applies to manual, while NWBO itself is telling the market that Flaskworks/Grade C is the core of its future commercial manufacturing. Once Flaskworks is the intended commercial process, it has to be in scope, and that’s exactly why a CMC update and a sponsor-side clock stop are the most logical explanations for the extended timeline.
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