Wednesday, April 29, 2026 6:49:38 AM
It’s a question of stage. It could sound endless, but the MHRA process is an external time keeper, so it’s not endless.
Even entering the MHRA process demonstrated some belief by NWBO (and I believe their less formal discussions with nice/mhra) that they were mature enough to engage in the maa process — albeit, w/my rearview vision, I think they knew they’d need more maturation within the maa process than most, and their definition of clock on and clock off would resemble a warped clock in a surrealist painting.
So what did George Z mean that full versus conditional approval was left to be determined? It comes down to stage, and the stage is 153 calendar days post likely successful second CHM.
The science is good, the new regs are activated, the manufacturing is a go, the initial external leukapheresis clinics are already contracted and trained with a larger NWBO leuk clinic being prepared inside a hospital for further expansion. IMO.
Well, what are we waiting for?
Even entering the MHRA process demonstrated some belief by NWBO (and I believe their less formal discussions with nice/mhra) that they were mature enough to engage in the maa process — albeit, w/my rearview vision, I think they knew they’d need more maturation within the maa process than most, and their definition of clock on and clock off would resemble a warped clock in a surrealist painting.
So what did George Z mean that full versus conditional approval was left to be determined? It comes down to stage, and the stage is 153 calendar days post likely successful second CHM.
The science is good, the new regs are activated, the manufacturing is a go, the initial external leukapheresis clinics are already contracted and trained with a larger NWBO leuk clinic being prepared inside a hospital for further expansion. IMO.
Well, what are we waiting for?
Recent NWBO News
- CNS Drug Delivery Breakthroughs Unlock Significant Biotech Market Opportunities • InvestorsHub NewsWire • 05/11/2026 01:00:00 PM
- CNS Drug Delivery Breakthroughs Unlock Significant Biotech Market Opportunities • GlobeNewswire Inc. • 05/11/2026 12:30:00 PM
- Northwest Biotherapeutics Appoints Dr. Annalisa Jenkins As Strategic Adviser To Advance Dendritic Cell Cancer Vaccine Platform • PR Newswire (US) • 04/30/2026 04:38:00 PM
- Northwest Biotherapeutics Appoints Dr. Annalisa Jenkins As Strategic Adviser To Advance Dendritic Cell Cancer Vaccine Platform • PR Newswire (US) • 04/30/2026 04:30:00 PM
- Northwest Biotherapeutics Announces Establishment Of the Company's Own Dedicated Leukapheresis Clinic • PR Newswire (US) • 04/21/2026 01:30:00 PM
- 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
