Flipper’s post was flagged and now shows as “Searching for Moderation” so I’m reposting the key content here because ironically I think he actually proved the case even further.
He quoted NICE directly stating that they can only appraise drugs that either already have a UK license or are expected to receive one during the appraisal process. That is accurate. But then he cited the July 15 NICE letter which says:
“NWBO reports that it is still fully occupied and engaged in the Marketing Authorisation Application (MAA) process with the MHRA”
and
“the company are not yet in a position to provide their evidence submission with us”
That language is critical. It does not suggest rejection or pause. It shows NWBO is actively working inside the MAA which places them in the final stage of the process: labeling. This is the phase that begins once an internal decision to approve has been made. It involves finalizing the Summary of Product Characteristics or SmPC which defines the indication safety profile manufacturing terms and patient eligibility.
NICE cannot begin any appraisal or modeling without the SmPC. When they say they “await further contact” from NWBO that means they are standing by for that final document. The company has not submitted it yet because MHRA is still finalizing it with them.
This proves the MAA is alive and still in motion. The letter confirms that NWBO is inside the labeling phase not waiting for approval but implementing it.
So while Flipper may have thought this undercut the case it actually reinforces it. The decision is made. The handoff is being prepared. NICE is waiting for the formal label and the moment that arrives the next phase begins.
If this was flagged by someone hoping to bury it the effect is the opposite. This is confirmation.
Here was my response to Flipper:
Flipper, your quote actually proves the point, just not in the way you intended.
NICE says they can only appraise drugs that either have a UK licence or are expected to receive one during their appraisal. The July 15 NICE letter confirms that NWBO hasn’t submitted their evidence yet, because they are still “fully occupied and engaged” in the MAA process with MHRA. That tells us exactly where they are: not waiting to apply, not paused, just actively finishing the process.
This stage is the labeling phase.
Once MHRA decides to approve a drug, it doesn’t immediately get published. The next step is to draft and finalize the Summary of Product Characteristics (SmPC), which defines the indication, safety information, patient eligibility, and manufacturing terms. This document is required before NICE can begin modeling value or issuing recommendations. Until the SmPC is finalized, NICE appraisal cannot start, not under path one, and not under path two.
And that’s exactly what the July 15 letter reflects. NICE is not appraising yet, not because MHRA hasn’t made a decision, but because the company hasn’t submitted the required documentation. Why haven’t they? Because it’s still being finalized with MHRA behind the scenes.
That is what “still fully occupied and engaged in the MAA process” means.
You’ve actually confirmed what many of us suspected. The decision to approve has already been made internally. NWBO is now in the labeling phase. NICE is standing by for the SmPC and formal handoff. This is the last administrative step before publication and value modeling. Nothing about this suggests uncertainty, only that the approval is not yet public.
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