NorthWest Biotherapeutics Inc (NWBO)

[Slave1]

That pathway exists, but the governing rule is which procedure applies to the application, not whether the pathway exists in general.

DCVax-L was submitted in late 2023 and entered MHRA assessment before the 2025 National Assessment Procedure took effect. There is no public indication of a restart, re-submission, or formal conversion into the 2025 framework. Under the pre-2025 procedure, a 28-day CHM letter is procedurally tied to major objections, not automatically issued following a non-negative CHM advisory outcome.

The CHM minutes state that the Commission considered and advised on the glioblastoma MAA and do not reference major objections, minor outstanding issues, representations, or follow-up correspondence. The ASM disclosures are consistent with normal regulatory progression rather than an active objections or representations phase.

So the language you’re quoting describes a valid pathway under the 2025 procedure, but based on timing and the public record, there’s no basis to assume that specific 28-day Advice Letter step was triggered in this case.