Monday, October 20, 2025 2:31:39 PM
“MHRA has only been on the clock for 210 days”? That’s complete nonsense and a lie.
The MHRA doesn’t have a public clock like the EMA did pre-Brexit. Nobody outside NWBO or the MHRA knows how many assessment days have actually run and quoting “210 days” just shows you’re applying your rear end fantasy again.
LP already said the first RFI was delayed due to MHRA backlog. Every RFI cycle pauses and restarts the review. Three cycles (standard for a complex biologic) = easily 18-20 months total. That’s not “a problem,” that’s normal for first-in-class autologous therapies. If the application was in hot water the file would’ve been rejected long ago. The fact that the review is still active after nearly two years says the opposite MHRA is refining, not rejecting.
Had NWBO received a negative recommendation letter than they have to disclose that in the last 10Q and I have not read anything about that
It does not surprise me good luck with that
The MHRA doesn’t have a public clock like the EMA did pre-Brexit. Nobody outside NWBO or the MHRA knows how many assessment days have actually run and quoting “210 days” just shows you’re applying your rear end fantasy again.
LP already said the first RFI was delayed due to MHRA backlog. Every RFI cycle pauses and restarts the review. Three cycles (standard for a complex biologic) = easily 18-20 months total. That’s not “a problem,” that’s normal for first-in-class autologous therapies. If the application was in hot water the file would’ve been rejected long ago. The fact that the review is still active after nearly two years says the opposite MHRA is refining, not rejecting.
Had NWBO received a negative recommendation letter than they have to disclose that in the last 10Q and I have not read anything about that
Clearly there is a major issue.
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
