Wednesday, July 16, 2025 9:12:35 PM
There’s much we don’t fully grasp until approval drops and the underlying facts come to light. I’ve laid out my reasoning—challenge, run with it, or reject it.
Consider this:
-- The MHRA’s adoption of the Decentralized Point-of-Care Manufacturing Framework uniquely aligns with NWBO's platform—no other company with a drug pending approval shares this compatibility.
-- DCVax-L’s indication was updated from glioblastoma to “cancer”, hinting at expanded therapeutic demand requiring a much larger commercial footprint.
-- The approval timeline, originally estimated at 150 days, has now stretched beyond 500. Add Linda Powers’ statement in the 10K: “The Company has been holding off on proceeding with the fabrication of the Flaskworks system until regulatory feedback is received.” That, to me, signals that feedback—expressed publicly in the form of MHRA’s framework—has likely arrived.
Am I absolutely certain? Hell no. But does this scenario hold water and seem reasonable? Hell yes.
Consider this:
-- The MHRA’s adoption of the Decentralized Point-of-Care Manufacturing Framework uniquely aligns with NWBO's platform—no other company with a drug pending approval shares this compatibility.
-- DCVax-L’s indication was updated from glioblastoma to “cancer”, hinting at expanded therapeutic demand requiring a much larger commercial footprint.
-- The approval timeline, originally estimated at 150 days, has now stretched beyond 500. Add Linda Powers’ statement in the 10K: “The Company has been holding off on proceeding with the fabrication of the Flaskworks system until regulatory feedback is received.” That, to me, signals that feedback—expressed publicly in the form of MHRA’s framework—has likely arrived.
Am I absolutely certain? Hell no. But does this scenario hold water and seem reasonable? Hell yes.
"Against stupidity, we are defenseless"-- Dietrich Bonhoeffer, an anti-Nazi German Theologian, executed in the final days of the Nazi regime.
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
