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Re: A deleted message

Thursday, 07/17/2025 10:33:38 AM

Thursday, July 17, 2025 10:33:38 AM

Post# of 823833
When someone resorts to insults instead of substance, it’s usually because they can’t refute the actual argument.

The July 15 NICE letter states that NWBO is still fully occupied and engaged with the MHRA and not yet in a position to submit to NICE. NICE also says they are awaiting further contact. That confirms the MAA is active and that the company hasn’t reached the handoff point. At this late stage of a review, that remaining step is almost always the finalisation of the SmPC.

This is not about AI or speculation. It’s about process. NICE cannot legally begin appraisal until it receives a draft or final SmPC. That’s outlined clearly in their published guidelines (PMG24). The language in the letter matches that point in the sequence exactly.
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