NorthWest Biotherapeutics Inc (NWBO)

[Slave1]

What you’re describing conflates manufacturing law with the marketing authorisation assessment procedure, and MHRA treats those as separate tracks.

SI 2025 No. 87 did become law in July 2025 and applies prospectively to manufacturing and licensing. That’s why MHRA can issue or vary a Manufacturer’s Licence using concepts like Control Sites and decentralised manufacture. The December 15 MIA shows Sawston meets current GMP and control-site requirements. It does not determine which assessment procedure governs the MAA.

The National Assessment Procedure is different. MHRA’s own guidance states that the 2025 procedure applies to applications received after April 3, 2025. There is no provision that automatically transitions pending MAAs into the new assessment timetable simply because manufacturing law changed. If an application is formally restarted, re-submitted, or converted, that is a procedural event and leaves a trace. There is no public indication of that here.

MHRA routinely runs these tracks in parallel. A product can be assessed under the pre-2025 MAA procedure while its manufacturing is updated to comply with newer law. That is normal regulatory practice, not a loophole.

So two things can be true at the same time. Manufacturing can be governed by 2025 standards, and the MAA assessment can still be governed by the pre-2025 procedure. The December 15 MIA is evidence of the former, not proof of the latter.

Absent evidence of a formal procedural conversion, the correct reading remains that DCVax-L’s MAA is being assessed under the pre-2025 National Assessment Procedure, while its manufacturing has been brought into compliance with 2025 law.