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Re: A deleted message

Thursday, 12/18/2025 3:31:12 PM

Thursday, December 18, 2025 3:31:12 PM

Post# of 828947
The MHRA’s language focuses on the intended commercial manufacturing route, not simply on whether an older process might still be used in parallel or as a contingency. If NWBO can credibly represent to the MHRA that the manual process is genuinely intended for commercial use at approval, with Flaskworks positioned as a post-approval change, then your interpretation is correct and Flaskworks would not be MA-critical.

Where I see potential risk is that once Flaskworks is described with specific timelines and positioned as the clear endpoint, the regulator may reasonably question whether the manual process truly reflects long-term commercial intent or is merely a bridge.

As I have repeatedly said here before: if, shortly after a manual-based MA is granted, NWBO submits a request to switch to Flaskworks as the sole and primary manufacturing method — as they have indicated they intend to do in their latest press release and in GZ’s email to me — then you risk a very irritated MHRA that may feel misled, and the previously granted manual MA could be suspended.

So yes, it is possible for NWBO to mislead the MHRA. That scenario cannot be ruled out.
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