Replies to post #778405 on NorthWest Biotherapeutics Inc (NWBO)

[Slave1]

Great question gwm61 and it’s a critical one for understanding where things stand.

While the MHRA doesn’t publicly declare when the labeling phase begins, we can triangulate it using the NICE letter dated July 15, 2025. In that response, NICE confirmed that NWBO was still engaged in the MAA process and not yet in a position to submit their evidence. That statement implies the company had not yet received its draft SmPC, which under NICE PMG24 is a required component of submission.

The draft SmPC only becomes available after MHRA completes its internal review and enters the labeling phase. So it’s reasonable to infer that the labeling phase began shortly after July 15, likely between July 16 and July 20.

Labeling typically takes 2 to 4 weeks, depending on product class and regulatory negotiation pace. For ATMPs under SI 87, it’s not unusual for the longer end of that range to apply due to manufacturing specificity and QP sign-off.

That gives us an estimated labeling window of:

Start: Between July 16–20
End (projected): Between July 30–August 13

So as of today (July 28), we are almost certainly midway through the labeling phase, with final SmPC issuance, and NICE submission, expected within the next 2 to 14 days, assuming no deferrals.