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manibiotech

08/13/25 10:05 PM

#781269 RE: Slave1 #781268

"Yes, because nothing in the public record has changed that sequence. The August 12 FOI reply confirmed CHM already discussed a brain cancer medicine in May–June and that minutes are withheld only under Section 22(1), which is used when the discussion and documentation already exist and are queued for publication. The July 15 NICE letter stated NWBO is still “fully occupied and engaged” with MHRA and “not yet in a position” to submit evidence, exactly what you’d expect while the final SmPC is being completed"
None of that implies that they have approved it or are in labeling phase yet. I posted GPT5's reply as well which also says that all it means is that it was discussed in the meeting and doesn't imply that approval was definite outcome of that meeting . That is your interpretation . Fully engaged can mean anything , can mean still answering questions . 
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Slave1

08/13/25 10:44 PM

#781273 RE: Slave1 #781268

“Fully engaged can mean anything” ignores the actual rules. Section 22(1) is only used when CHM minutes already exist and are queued for publication — that means the meeting happened and the record is in the release pipeline. NICE’s own PMG24 requires the final SmPC before it will accept a submission, so “not yet in a position” signals the label isn’t finalised. Label drafting only happens after MHRA’s internal approval decision because every word becomes legally binding for indication, dosing, and safety. The standard sequence is: CHM complete, then label finalisation, then public licence, then NICE appraisal.
Bullish
Bullish