Friday, March 18, 2022 1:40:54 PM
And MHRA approval is not coming this year, unfortunately! I know all the loyal supporters are going to say that’s BS and how do I know. But the fact remains any well run company will let shareholders know that their (UK) BLA application was accepted. This is a significant event. And there is no such PR yet, so it’s safe to assume it’s pending. And by the way, these same folks (loyal management supporters) were like you don’t submit BLA before TLD when questioned on why they have made limited (parallel) progress on RA in the last year or so. They can’t have both ways! ;)
For me personally, if they don’t update the clinical trials website in a few weeks after the final FDA guideline document comes out (which I anticipate before end of April) then I have serious concerns about their FDA pathway and chances of success there. So I think the next 2 months will provide a great deal of clarity!
Having said that, I do believe they are likely to get UK and EU approvals, but unfortunately they are not coming this year. Waiting game will continue!
For me personally, if they don’t update the clinical trials website in a few weeks after the final FDA guideline document comes out (which I anticipate before end of April) then I have serious concerns about their FDA pathway and chances of success there. So I think the next 2 months will provide a great deal of clarity!
Having said that, I do believe they are likely to get UK and EU approvals, but unfortunately they are not coming this year. Waiting game will continue!
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
