Friday, July 25, 2025 2:20:35 PM
I appreciate the pushback Mike, and you’re absolutely right to differentiate between quoting and interpreting. Just to be clear: NICE did not say, word-for-word, that they’re “waiting on NWBO.” The actual quote is:
“The company are not yet in a position to provide their evidence submission with us.”
That’s what was said. What I offered was an interpretation of what that line structurally implies, based on how the MHRA–NICE process normally operates.
In NICE’s standard workflow, they don’t begin engagement until MHRA has either granted a marketing authorisation or signaled that one is imminent. If MHRA were still conducting active review, we would expect NICE to reference that. Instead, they shift focus entirely to the company, not to MHRA, not to ongoing regulatory dialogue. That shift doesn’t confirm anything on its own, but it’s a meaningful procedural indicator. It suggests the handoff from regulator to sponsor has likely occurred, placing the next move in NWBO’s hands. That isn’t a fantasy narrative, it’s an inference grounded in the documented structure of how these transitions work.
And while you’re right that “not in a position to submit” could stem from various internal reasons, this is the first time NICE has publicly acknowledged DCVax-L in this context. That alone is new. So yes, it’s possible this reflects a final labeling phase. It’s also possible it reflects internal readiness or coordination. But recognizing the structural pattern here isn’t irresponsible, it’s analytical. This isn’t a declaration of approval, nor is it a direct quote. It’s a reasoned interpretation of where we likely are based on what NICE did, and didn’t say, aligned with MHRA’s published process and timelines.
“The company are not yet in a position to provide their evidence submission with us.”
That’s what was said. What I offered was an interpretation of what that line structurally implies, based on how the MHRA–NICE process normally operates.
In NICE’s standard workflow, they don’t begin engagement until MHRA has either granted a marketing authorisation or signaled that one is imminent. If MHRA were still conducting active review, we would expect NICE to reference that. Instead, they shift focus entirely to the company, not to MHRA, not to ongoing regulatory dialogue. That shift doesn’t confirm anything on its own, but it’s a meaningful procedural indicator. It suggests the handoff from regulator to sponsor has likely occurred, placing the next move in NWBO’s hands. That isn’t a fantasy narrative, it’s an inference grounded in the documented structure of how these transitions work.
And while you’re right that “not in a position to submit” could stem from various internal reasons, this is the first time NICE has publicly acknowledged DCVax-L in this context. That alone is new. So yes, it’s possible this reflects a final labeling phase. It’s also possible it reflects internal readiness or coordination. But recognizing the structural pattern here isn’t irresponsible, it’s analytical. This isn’t a declaration of approval, nor is it a direct quote. It’s a reasoned interpretation of where we likely are based on what NICE did, and didn’t say, aligned with MHRA’s published process and timelines.
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
