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.
That combination strongly suggests the internal approval decision has already been made. At this point, the process is in label finalisation, a delicate stage where every word, dosing parameter, warning, and eligibility criterion in the SmPC is locked down. That document becomes the legal licence, and once issued, it governs every subsequent appraisal and reliance-market filing. Any mistake or ambiguity in that label would create regulatory and commercial headaches later, so it’s standard practice to get it right behind closed doors before anything is announced.
The process is: CHM review, then label finalisation, then public licence, then NICE appraisal. Until MHRA announces, the most logical read is that they remain in the final label stage, and the absence of public noise is exactly how this part of the process works. And August isn’t over just yet.
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