NorthWest Biotherapeutics Inc (NWBO)

[Slave1]

Meirluc,

Yes, those two things can both be true.

The “cannot comment on the status of applications during the review process” line is MHRA’s standard boilerplate. They’ll use that for any active MAA when speaking to the public, regardless of where it sits in the timeline. They won’t officially confirm, “We’re in labeling,” even if they are.

That’s why you have to read it in context with other signals:

• FOI reply to Lykiri – confirms a brain cancer medicine was discussed at the May/June CHM meeting, which is one of the final steps before approval, and that details are withheld until the CHM minutes are published. That’s consistent with label wording and final conditions being discussed.

• NICE letter (July 15) – says NWBO is “still fully engaged” in the MHRA MAA process but “not yet in a position” to submit to NICE. NICE can only accept a submission once the final SmPC (label) is approved by MHRA, so “not yet in a position” is basically “we don’t have the label yet.”

Put those together and the picture is clear:
• CHM has already met ? label draft reviewed.
• NICE is waiting for that label to be final ? standard end-game sequence.
• MHRA is still “fully engaged” with NWBO ? finalisation work in progress.

So while MHRA will always give the non-committal “cannot comment” answer to a public query, the combination of FOI confirmation + NICE’s wording points to the process being in the labeling/finalisation stage, not a mid-review RFI cycle.

In other words, the boilerplate response is just their way of staying inside confidentiality rules, it doesn’t contradict the labeling interpretation when you look at the other evidence.