Sunday, March 23, 2025 4:25:00 PM
There is no way to convince you the timeline for (assumed) approval has not been abhorrent and disappointing. LP stated biotech investing, including venture capital, is not for the faint of heart.
Personally, I find the process completely revolting, but the MAA, according to at least a few well regarded posters, still has a pulse and
is, from looking at averages, still within a typical approval window for this type of technology. One DD guru puts May 6 or 7 as his worry date, if no approval on or before that time.
I won’t be posting here after April 7 if no approval by then. One thing that bothers me immensely about the process is that despite the fact the agency knows this technology inside and out, the agency has supposedly highly prioritized this cancer indication, supposedly prioritized this amazing and unprecedented type of safety profile, know its potential, understand its impact on long term survival, have over a decade experience with the therapy in compassionate treatment, picked through and certified all relevant manufacturing, understand patient need, and despite all that, they’re incredibly slow.
Patients are waiting.
Personally, I find the process completely revolting, but the MAA, according to at least a few well regarded posters, still has a pulse and
is, from looking at averages, still within a typical approval window for this type of technology. One DD guru puts May 6 or 7 as his worry date, if no approval on or before that time.
I won’t be posting here after April 7 if no approval by then. One thing that bothers me immensely about the process is that despite the fact the agency knows this technology inside and out, the agency has supposedly highly prioritized this cancer indication, supposedly prioritized this amazing and unprecedented type of safety profile, know its potential, understand its impact on long term survival, have over a decade experience with the therapy in compassionate treatment, picked through and certified all relevant manufacturing, understand patient need, and despite all that, they’re incredibly slow.
Patients are waiting.
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
