NorthWest Biotherapeutics Inc (NWBO)

[Lykiri]

That clock stop is specific to the case when the sponsor was sent a CHM Letter stating the MHRA has major objections.

There is just no way around it. Either NWBO received a CHM letter or LP has had the clock in her hand for more time than the MHRA. Ex post 699984

Exwannabe,
You know very well that DCVax-L falls under the earlier MHRA guidance, not the new one you keep citing. As has been discussed many times on this board, under that earlier framework, every application for a new innovative medicine was routinely referred to a second CHM meeting before a final recommendation was made. Given that context — and the clear shift in the process after the first CHM meeting — why do you continue to invoke the new guidance in a way that only sows confusion about the status of this application?

For those interested: here is a link to a May 6 webinar explaining the new guidance:

https://www.gov.uk/guidance/national-assessment-procedure-for-medicines

National assessment procedure for medicines
Guidance on the MHRA’s national assessment procedure for marketing authorisation applications.

From:
Medicines and Healthcare products Regulatory Agency
Published
3 April 2025

1. Introduction

1.1 Overview

We offer a national assessment procedure for UK-wide marketing authorisation (MA) applications. This new guidance for applicants is effective for applications received after the publication date. We keep our processes and metrics under continual review, and we may update this guidance if needed.