Tuesday, September 23, 2025 11:51:37 AM
the point of that timeline exercise was to see approximately how far the application could go without being considered "backlogged" on the part of the MHRA or Northwest.
I personally think (as you laid out) according to MHRA’s National Assessment timeline, they are nearing the outer limits of being considered backlogged. However, a view of the MHRA’s Performance Metrics Assessment over most of this period, shows this time period is about average:
Performance Metrics Assessment of New Marketing Authorisation Applications and Variations (January 2023 - February 2025)
As far as the Advent acquisition PR, I think almost everyone noticed that sentence, which certainly implies confidence. Whether it was intentional, or a “slip” we’ll probably never know, but we do know that lawyers are usually very careful with their language, so my take is that it was intentional.
I’ve always thought that the application would be approved, and thought it possible that it could receive priority review. My worst-case scenario was that the application would be delayed because there were deficiencies that needed to be addressed. I don’t think the assessment process is adversarial (as some here want everyone to believe), and I believe the MHRA wants to assist small companies that have developed innovative treatments, (particularly for Glioblastoma) to get them through the approval process, so they can make them available to their citizens.
And BTW - I also disagree with AI's assessment (but I’m not a fan of AI being used this way).
It seems clear to me that “potential” is describing “acceleration” that immediately follows it.
Recent NWBO News
- Northwest Biotherapeutics Announces Establishment Of the Company's Own Dedicated Leukapheresis Clinic • PR Newswire (US) • 04/21/2026 01:30:00 PM
- Northwest Biotherapeutics Announces Establishment Of the Company's Own Dedicated Leukapheresis Clinic • PR Newswire (US) • 04/21/2026 01:30:00 PM
- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 04/21/2026 04:15:08 AM
- Form POS AM - Post-Effective amendments for registration statement • Edgar (US Regulatory) • 04/16/2026 09:25:30 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 04/07/2026 04:30:50 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) • 03/31/2026 09:04:37 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/15/2026 10:06:20 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/02/2026 10:14:59 PM
- Form DEF 14A - Other definitive proxy statements • Edgar (US Regulatory) • 11/28/2025 09:43:27 PM
- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 11/25/2025 10:23:07 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/20/2025 09:26:03 PM
- Form PRE 14A - Other preliminary proxy statements • Edgar (US Regulatory) • 11/19/2025 09:15:48 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 11/14/2025 09:44:21 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 10/31/2025 04:29:10 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 10/30/2025 08:40:05 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 10/24/2025 04:28:38 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 10/14/2025 06:22:26 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/14/2025 09:00:38 PM
- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 07/01/2025 09:04:38 PM
