Friday, July 25, 2025 2:26:33 PM
Totally fair, and your analogy is actually a good one. You’re right that unless someone’s inside the MHRA, we can’t know for certain when an internal decision was made. But in your lawncare example, while Company X might not know they were selected yet, if someone called the homeowners association and was told, “We’re just waiting on the homeowner to submit the paperwork,” that would pretty strongly suggest a decision has already been made.
That’s the situation we’re in with NICE. They didn’t say, “We’re waiting on MHRA,” or “The regulator is still reviewing.” They said, “The company is not yet in a position to provide their evidence submission.” Structurally, that suggests the regulator’s role is likely complete, or close to it, and now it’s on NWBO to finalize and submit. That doesn’t prove approval has occurred, but in the context of MHRA’s published process (label finalization, sponsor consultation, press release within 7 days, PAR within 30), it’s a meaningful signal of where we are.
So you’re right, we don’t know the exact internal timing. But based on how these steps normally unfold, and what’s been said publicly, we can make a well-reasoned inference that we’re no longer in the middle of the review. We’re in the final stretch before disclosure.
That’s the situation we’re in with NICE. They didn’t say, “We’re waiting on MHRA,” or “The regulator is still reviewing.” They said, “The company is not yet in a position to provide their evidence submission.” Structurally, that suggests the regulator’s role is likely complete, or close to it, and now it’s on NWBO to finalize and submit. That doesn’t prove approval has occurred, but in the context of MHRA’s published process (label finalization, sponsor consultation, press release within 7 days, PAR within 30), it’s a meaningful signal of where we are.
So you’re right, we don’t know the exact internal timing. But based on how these steps normally unfold, and what’s been said publicly, we can make a well-reasoned inference that we’re no longer in the middle of the review. We’re in the final stretch before disclosure.
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
