NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

FeMike, the reason this means something different now than it might have a year ago is because of timing, sequence, and the structure of the MHRA review process. This is not about reinterpreting the same words arbitrarily. It is about what those words mean at this specific point in the review.

You are making a speculative argument dressed up as procedural certainty. While the regulatory framework you reference is accurate, your interpretation of the NICE letter as proof NWBO is in the labeling phase is not justified.

The NICE response confirms only:
NWBO is still “fully occupied” with the MHRA process.
NWBO has not yet submitted evidence to NICE.

From that, you are assuming:
The MAA review is concluded.
The MHRA has already decided positively.
The only remaining task is finalizing the SmPC.

That is not a fact it’s a narrative based on procedural expectations, not actual disclosed status. Regulatory authorities use vague language during active reviews for a reason.

“Fully occupied and engaged

could easily describe an applicant working through final MHRA questions, clarifications, or procedural steps, not necessarily labeling.

Your argument is optimistic but overconfident, treating "still engaged in the MAA" as proof of internal approval when, in reality, that same language would apply to a sponsor responding to final-stage issues or even negotiating risk-benefit messaging.
What you are saying is possible, but there’s no hard evidence that NWBO is in labeling. Assuming so based solely on NICE’s general phrasing is wishful thinking