NorthWest Biotherapeutics Inc (NWBO)

[Slave1]

“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.