Monday, August 05, 2024 10:31:41 PM
Right kab, apparently the MHRA doesn’t officially confirm on which pathway the application is being reviewed, but as I said, I think Northwest Bio does actually know that it’s under an accelerated priority review.
As far as the number of site visits, my speculation would be a handful at most. I know the FDA physically inspects a little over 1% of clinical trial sites, so my assumption is that the MHRA is somewhat similar. And yes, we know that preparation is key, and it sounds like Northwest Bio and their contractors spent significant time and resources to ensure that every site was very well prepared.
As far as the number of site visits, my speculation would be a handful at most. I know the FDA physically inspects a little over 1% of clinical trial sites, so my assumption is that the MHRA is somewhat similar. And yes, we know that preparation is key, and it sounds like Northwest Bio and their contractors spent significant time and resources to ensure that every site was very well prepared.
Recent NWBO News
- CNS Drug Delivery Breakthroughs Unlock Significant Biotech Market Opportunities • InvestorsHub NewsWire • 05/11/2026 01:00:00 PM
- CNS Drug Delivery Breakthroughs Unlock Significant Biotech Market Opportunities • GlobeNewswire Inc. • 05/11/2026 12:30:00 PM
- Northwest Biotherapeutics Appoints Dr. Annalisa Jenkins As Strategic Adviser To Advance Dendritic Cell Cancer Vaccine Platform • PR Newswire (US) • 04/30/2026 04:38:00 PM
- Northwest Biotherapeutics Appoints Dr. Annalisa Jenkins As Strategic Adviser To Advance Dendritic Cell Cancer Vaccine Platform • PR Newswire (US) • 04/30/2026 04:30:00 PM
- Northwest Biotherapeutics Announces Establishment Of the Company's Own Dedicated Leukapheresis Clinic • PR Newswire (US) • 04/21/2026 01:30:00 PM
- 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
