NorthWest Biotherapeutics Inc (NWBO)

[Slave1]

You’re absolutely right that MHRA approvals are published regularly, and that NICE and MHRA decisions are independent. There are indeed cases where MHRA grants approval but NICE later declines reimbursement. No disagreement there.

The key point here isn’t about NICE needing to approve anything, it’s that the July 15 NICE letter makes clear MHRA is no longer the active step. When NICE says the company “is not yet in a position to submit,” it indicates the handoff has already occurred. That aligns with MHRA protocol: after internal approval, the agency works with the sponsor to finalize the label (SmPC), PAR, and any public materials. A press release is typically issued within 7 days, and the PAR is published within 30–60 days, depending on classification. During that time, the company is reviewing and aligning on the final content with MHRA, quietly.

Regarding shareholder communication, there’s no rule preventing disclosure, but it’s standard practice, especially in high-stakes reviews, for companies to wait until final documents are locked and regulator-approved. Premature announcements risk misalignment with MHRA wording, and could complicate or delay publication. NWBO may simply be exercising regulatory discipline: waiting until the press release and PAR are ready to go live in sync. That’s not silence due to trouble, it’s structure.