Thursday, July 17, 2025 10:33:38 AM
When someone resorts to insults instead of substance, it’s usually because they can’t refute the actual argument.
The July 15 NICE letter states that NWBO is still fully occupied and engaged with the MHRA and not yet in a position to submit to NICE. NICE also says they are awaiting further contact. That confirms the MAA is active and that the company hasn’t reached the handoff point. At this late stage of a review, that remaining step is almost always the finalisation of the SmPC.
This is not about AI or speculation. It’s about process. NICE cannot legally begin appraisal until it receives a draft or final SmPC. That’s outlined clearly in their published guidelines (PMG24). The language in the letter matches that point in the sequence exactly.
The July 15 NICE letter states that NWBO is still fully occupied and engaged with the MHRA and not yet in a position to submit to NICE. NICE also says they are awaiting further contact. That confirms the MAA is active and that the company hasn’t reached the handoff point. At this late stage of a review, that remaining step is almost always the finalisation of the SmPC.
This is not about AI or speculation. It’s about process. NICE cannot legally begin appraisal until it receives a draft or final SmPC. That’s outlined clearly in their published guidelines (PMG24). The language in the letter matches that point in the sequence exactly.
Bullish
Recent NWBO News
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- Northwest Biotherapeutics Announces Establishment Of the Company's Own Dedicated Leukapheresis Clinic • PR Newswire (US) • 04/21/2026 01:30:00 PM
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- 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
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- 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
