NorthWest Biotherapeutics Inc (NWBO)

[Lykiri]

Either:

A) MHRA is lying
B) MHRA made a decision to not approve.
C) Still in progress with over 180 clock off days
D) Withdrawn

Come on boys, somebody find a timeline that makes sense and does not show either MHRA or NWBO is [self-censored to avoid Senti's wrath]'d up.

Ex, I can propose a plausible timeline based on the available information, but of course, it’s just my opinion.

Feb.20, 2025: The GMP certification for NWBio's Sawston facility.(fact)
End of Feb.2025: Submission of the final inspection report to MHRA.(This is day 181 in the EMA process, and it is likely similar for the procedure with the MHRA.)
By late March 2025, the MHRA had finalized its full assessment of the DCVax-L marketing authorisation application.

MHRA Performance Data
Updated 16 April 2025

On 31 March 2025, we cleared all backlogs related to licence applications for innovative and established medicines.

https://www.gov.uk/government/publications/mhra-performance-data/mhra-performance-data

First week of April 2025, the assessment team finalised their report with recommendations intended for consideration at the CHM meeting on April 24.

The functions of the CHM are:
• to advise the Health Ministers and the Licensing Authority (LA) on matters relating
to human medicinal products including giving advice in relation to the safety, quality
and efficacy of human medicinal products where either the Commission thinks it
appropriate or where it is asked to do so;
• to consider those applications where the LA has a statutory duty to refer to the CHM
or chooses to do so;
• to consider representations made (either in writing or at a hearing) by an applicant
or by a licence or marketing authorisation holder in certain circumstances;
• to promote the collection and investigation of information relating to adverse
reactions to human medicines for the purposes of enabling such advice to be given

.

In 2023, the CHM was asked to advise on 187 papers over 12 meetings. Of these, 85 papers were related to final licensing advice.
https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=&ved=2ahUKEwj109ub5PaMAxUwfKQEHXBrDBkQFnoECBgQAQ&url=https%3A%2F%2Fassets.publishing.service.gov.uk%2Fmedia%2F66a8eda4ab418ab055592fd6%2FCommission_on_Human_Medicines_Annual_Report_2023.pdf&usg=AOvVaw34mJUKs85N_Un13HXq-3q3&opi=89978449
One of the notable medicines reviewed was Casgevy (exagamglogene autotemcel), a gene therapy product using the innovative CRISPR gene-editing tool for the treatment of sickle cell disease and transfusion-dependent ß-thalassemia. This medicine was discussed during the CHM meeting on October 26, 2023, and the license was granted by the MHRA on November 15, 2023. This approval marked the first in the UK before any other country in the world.