Vator, that’s a fair question and I appreciate how you asked it. The term “labeling phase” can sound informal or speculative unless it’s anchored in the actual regulatory framework. But in this case, there’s strong procedural basis for the use of that term, especially in light of NICE’s own published guidance.
On July 15, 2025, NICE responded that Northwest Biotherapeutics was “not yet in a position to submit” its evidence package. According to NICE Submission Manual PMG24 (page 53), companies are not allowed to submit until the final Summary of Product Characteristics (SmPC) has been issued by the MHRA. That SmPC is only generated after MHRA approval has already been internally granted.
So if that letter from NICE is genuine, and there’s no reason to believe it’s not, it places NWBO in exactly the post-opinion, pre-announcement window. This is the formal administrative step where the MHRA drafts the legal label (SmPC), which NICE needs before it can accept the application. It’s procedural, not speculative.
Labeling is a common final step before public approval in most drug approval systems. In the UK, it’s just more clearly documented: the label (SmPC) cannot precede approval, and NICE cannot proceed without it. So “labeling phase” is just shorthand for this last known stage before approval becomes official.
It’s like the diploma at graduation. You’ve passed the exams. The committee has approved you. The work is done. But until the registrar prints the certificate, nothing can be handed over. That’s the stage we’re in.
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