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Thursday, May 16, 2024 11:09:48 AM
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.
Recent NWBO News
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- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/10/2024 09:04:57 PM
- Form NT 10-K - Notification of inability to timely file Form 10-K 405, 10-K, 10-KSB 405, 10-KSB, 10-KT, or 10-KT405 • Edgar (US Regulatory) • 03/01/2024 10:04:38 PM
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