Wednesday, August 13, 2025 12:10:12 AM
The MHRA decision takes as long as it takes. You can ATTEMPT to read meaning into the length of time that the application has been in the hands of MHRA all you want.
A decision has not yet been announced. You don't know why it has taken this long and neither do I.
I offer these thoughts.
What NWBO is doing is new to the system. We can see the system adjusting to the new way of doing things by the new set of regulations that have come out.
Bureaucracies move slowly when confronted with things outside their experience. That seems to be the case with NWBO.
There are many stakeholders in the MHRA system, cancer treatment systems, drug production systems and regulations that will be willing to challenge ANY decision that MHRA makes in relation to NWBO application.
MHRA has to get this right and to be able to defend its actions against all of the stakeholders both those that want DCVAX-L approved and those that don't.
A decision has not yet been announced. You don't know why it has taken this long and neither do I.
I offer these thoughts.
What NWBO is doing is new to the system. We can see the system adjusting to the new way of doing things by the new set of regulations that have come out.
Bureaucracies move slowly when confronted with things outside their experience. That seems to be the case with NWBO.
There are many stakeholders in the MHRA system, cancer treatment systems, drug production systems and regulations that will be willing to challenge ANY decision that MHRA makes in relation to NWBO application.
MHRA has to get this right and to be able to defend its actions against all of the stakeholders both those that want DCVAX-L approved and those that don't.
Nunc est Bibendum
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
