Sunday, September 21, 2025 8:43:09 PM
Sentiment, Your timeline is based on the MHRA’s official guidance:
- given where we are today
- procedurally it makes sense
- so a latest Nov 2, 2025 approval date also makes sense.
I'm looking at it differently but timing is in the same ballpark:
- I am thinking the gatekeeper is a review at the October 13-16 CHM meeting, then approval is 1 week later, late-October
- (slight chance, if reviewed at Sep 15-18 CHM meeting, then could be at the end of this month).
I am putting a high weight on these critical events:
- the new UK SI 2025 No. 87 on July 23, 2025
(speculation: NWBO amended MAA to include Flaskworks/Eden validation data)
- the acquisition of Advent BioServices on Aug 27, 2025
(interpretation: NWBO received internal signals for upcoming approval of Eden, ie start preparing for commercialization)
- given where we are today
- procedurally it makes sense
- so a latest Nov 2, 2025 approval date also makes sense.
I'm looking at it differently but timing is in the same ballpark:
- I am thinking the gatekeeper is a review at the October 13-16 CHM meeting, then approval is 1 week later, late-October
- (slight chance, if reviewed at Sep 15-18 CHM meeting, then could be at the end of this month).
I am putting a high weight on these critical events:
- the new UK SI 2025 No. 87 on July 23, 2025
(speculation: NWBO amended MAA to include Flaskworks/Eden validation data)
- the acquisition of Advent BioServices on Aug 27, 2025
(interpretation: NWBO received internal signals for upcoming approval of Eden, ie start preparing for commercialization)
Sharing thoughts and opinions. To participate in group due diligence. Motto: Do not be a gullible FUDdable investor.
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
