Friday, November 07, 2025 10:24:36 PM
learningcurve2020,
No need to rewrite what you posted because it was written to appease regulators and give a boiler plate disclaimer to investors against assuming approval will happen or when. This was purposely written this way so that the process of pursuing exceptions to adequate and well controlled studies could be followed. This would require an SAP with modified endpoints that regulators would first need to sign off on which is why the disclaimer was written in regarding the modification of the trial parameters. The missing 17 patients basically covers any modification of trial parameters just by mention of this one of reduced trial size as an example. That they already were pretty certain from the data why the 17 SOC/placebo patients were kept out and had to keep that under wraps was not necessary to disclose in making this disclaimer. You want simple when this was all nuanced for good reasons including trial integrity as long term data was being collected and the development of closed system commercial scale manufacturing was being pursued since 2014 with an indeterminate readiness date.
This all was happening while the share price was under attack after big pharma data from their own trial demonstrated greatly improved outcomes utilizing DC vaccine with checkpoint inhibitors and NWBO had applied for that combo patent. Whoops, don’t you just hate it when you find out that your own research shows you that your upstart pip squeak competitor has a better product than you do and outsmarted you with claims for the combo?; ). Best wishes.
No need to rewrite what you posted because it was written to appease regulators and give a boiler plate disclaimer to investors against assuming approval will happen or when. This was purposely written this way so that the process of pursuing exceptions to adequate and well controlled studies could be followed. This would require an SAP with modified endpoints that regulators would first need to sign off on which is why the disclaimer was written in regarding the modification of the trial parameters. The missing 17 patients basically covers any modification of trial parameters just by mention of this one of reduced trial size as an example. That they already were pretty certain from the data why the 17 SOC/placebo patients were kept out and had to keep that under wraps was not necessary to disclose in making this disclaimer. You want simple when this was all nuanced for good reasons including trial integrity as long term data was being collected and the development of closed system commercial scale manufacturing was being pursued since 2014 with an indeterminate readiness date.
This all was happening while the share price was under attack after big pharma data from their own trial demonstrated greatly improved outcomes utilizing DC vaccine with checkpoint inhibitors and NWBO had applied for that combo patent. Whoops, don’t you just hate it when you find out that your own research shows you that your upstart pip squeak competitor has a better product than you do and outsmarted you with claims for the combo?; ). Best wishes.
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
