Thursday, March 19, 2026 9:13:46 AM
Baxers,
Could be but during all this time Advent brought increased amounts of apheresis capacity in house, Class C only expansion plans and there was a delay with GMP certification of a compatible Flaskworks unit for the clean rooms. There was a classification change from GBM to cancer on the high priced medicines list for IFR consideration too. The exceptional circumstances for clock off seem to have been for various reasons and I consider closed system manufacturing readiness a top priority for regulators. As explained in a post from yesterday, NICE will put pressure on pricing if manufacturing costs are reduced and create initial price issues for high cost medicines based on quality life years which is obviously why reimbursement at profitable levels could not happen until 10 year data and the increase in pricing made this feasible in the short term and Flaskworks made this possible in the longer term. MHRA wants this treatment approved but the cost has ALWAYS been an issue limiting access to patients. These issues now look like they are being or have been resolved finally… with a little help from exceptions which I have been expecting to be part of this process for quite some time ; ). Best wishes.
Could be but during all this time Advent brought increased amounts of apheresis capacity in house, Class C only expansion plans and there was a delay with GMP certification of a compatible Flaskworks unit for the clean rooms. There was a classification change from GBM to cancer on the high priced medicines list for IFR consideration too. The exceptional circumstances for clock off seem to have been for various reasons and I consider closed system manufacturing readiness a top priority for regulators. As explained in a post from yesterday, NICE will put pressure on pricing if manufacturing costs are reduced and create initial price issues for high cost medicines based on quality life years which is obviously why reimbursement at profitable levels could not happen until 10 year data and the increase in pricing made this feasible in the short term and Flaskworks made this possible in the longer term. MHRA wants this treatment approved but the cost has ALWAYS been an issue limiting access to patients. These issues now look like they are being or have been resolved finally… with a little help from exceptions which I have been expecting to be part of this process for quite some time ; ). Best wishes.
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
