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Re: Slave1 post# 781273

Wednesday, 08/13/2025 11:21:25 PM

Wednesday, August 13, 2025 11:21:25 PM

Post# of 824046

“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


Yes. The meeting happened and the summary will be published sometime. And they will answer the asked question, "Was a brain cancer drug discussed". That answer will be either yes or no.

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


The NICE document states clearly only the draft SmPC is needed in the evidence submission. Anybody can open this and search for SmPC. The reason for a draft version being allowed is so companies can submit early allowing for a NICE opinion within a few months of MHRA action, as opposed to a year later.
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