Saturday, July 19, 2025 2:21:23 PM
Totally fair to disagree. I would just add that while a press release might have been appreciated by investors, from a regulatory standpoint it is plausible NWBO had reasons to hold off.
Flaskworks may have been referenced in the original MAA, but prior to SI 2025 No. 87 the MHRA had no legal framework to approve it as a modular Control Site. That regulation was laid before Parliament on June 17 and does not come into force until July 23. Before that date, including Flaskworks would have required a Type II variation, a major change that involves comparability studies, validation, and potential inspection.
Waiting until SI 87 is live would allow NWBO and MHRA to finalize everything in manufacturing, labeling, and packaging under one legal framework without triggering post approval variation. It is not about concealing anything. It is about structuring the license cleanly and avoiding regulatory friction. Until we hear otherwise, that scenario fits the timeline.
Flaskworks may have been referenced in the original MAA, but prior to SI 2025 No. 87 the MHRA had no legal framework to approve it as a modular Control Site. That regulation was laid before Parliament on June 17 and does not come into force until July 23. Before that date, including Flaskworks would have required a Type II variation, a major change that involves comparability studies, validation, and potential inspection.
Waiting until SI 87 is live would allow NWBO and MHRA to finalize everything in manufacturing, labeling, and packaging under one legal framework without triggering post approval variation. It is not about concealing anything. It is about structuring the license cleanly and avoiding regulatory friction. Until we hear otherwise, that scenario fits the timeline.
Bullish
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
