Wednesday, July 23, 2025 2:16:30 PM
jesster64 so what's your take on this. ??? If factual watch the share price tank big time ..imo
flyfishingcherokee
Re: skitahoe post# 777433
Wednesday, July 23, 2025 12:21:56 PM
Post#
777514
of 777546
Gary, It seems to me from reading the amendment to the regulation on Human Medicines that inserts the "Modular Manufacture and Point of Care regulations 2025" there are some parts which may cause delay in approval for NWBO and Advent to become authorized to be covered under the new regulation:
1. The new regulations "come into force six months after the date on which they are made". I read "made" to be "published' which is 7/23/2025. I hope there is evidence for an earlier "made" date, but I do not see it.
2. The amendment to Reg. 22 concerning application for a manufacturing license has several new requirements that must demonstrated and continue to be met in order to obtain and hold a license.
Consequently it appears that some six months will go by while applicant providers (NWBO and Advent) file the newly required supporting compliance information and the new regulations are allowed to become effective.
flyfishingcherokee
Re: skitahoe post# 777433
Wednesday, July 23, 2025 12:21:56 PM
Post#
777514
of 777546
Gary, It seems to me from reading the amendment to the regulation on Human Medicines that inserts the "Modular Manufacture and Point of Care regulations 2025" there are some parts which may cause delay in approval for NWBO and Advent to become authorized to be covered under the new regulation:
1. The new regulations "come into force six months after the date on which they are made". I read "made" to be "published' which is 7/23/2025. I hope there is evidence for an earlier "made" date, but I do not see it.
2. The amendment to Reg. 22 concerning application for a manufacturing license has several new requirements that must demonstrated and continue to be met in order to obtain and hold a license.
Consequently it appears that some six months will go by while applicant providers (NWBO and Advent) file the newly required supporting compliance information and the new regulations are allowed to become effective.
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
