NorthWest Biotherapeutics Inc (NWBO)

[hyperopia]

I think the 1st quarter 10Q was positive, and nothing in it has changed my opinion that the timing of marketing approval seems most likely in the 3rd quarter. It reads as though the application was complete, and there was not a request for further information after the first phase of assessment. Just like the application itself, Northwest Bio also seems well prepared for the manufacturing and clinical trial site visits that occur in the second phase of assessment.

Despite requesting a 150-day accelerated approval pathway, and being fully prepared for the rigors of assessment, Northwest Bio is not in control of the timing of the process. The most recent MHRA Performance metrics indicate that the MHRA is still considerably backlogged, even though they hired a number of new assessors last spring and summer, and hired a number of new inspectors late in the fall, and continue to hire inspectors currently.

Assessment of New Marketing Authorisation Applications and Variations April 2024

Validation for new MAAs – all submission routes

Average time to validation in days: 7

Numbers validated: 72

% validated within statutory time: 92


Work on hand

Overdue individual Product Licences from backlog of 1167 at 9 Jan 2024 (past the 210 days) as at 30 April 2024: 805 ****

**** Overdue individual Product licences (past the 210) days shows all pending abridged (biologicals removed) national licences (with current clock on or off) with regulatory clock on days over 210

https://assets.publishing.service.gov.uk/media/6644a44bbd01f5ed32793bdf/MHRA-Performance-Metrics_MAA-V_2301-2404.pdf

I’m looking forward to further updates at the Annual Shareholder Meeting that, according to the 10Q, should occur by the end of next month. I personally do not believe that they held off holding the meeting because they were waiting to discuss the marketing approval. Rather, that Linda Powers has been so overwhelmed with overseeing all the work required to prepare the marketing application last fall and winter, responding to information requests from the MHRA since the application was validated, and preparing the annual and first quarter SEC reports, that the ASM got pushed into the summer, simply because it was not as urgent.