Saturday, May 28, 2022 1:30:40 AM
Gary,
Here's my layman's thinking,
- OS is gold standard. Meeting the primary and first secondary endpoints is for NWBO to get what it wants, regulatory approval to market DCVax-L for the indications and labels of rGBM and ndGBM. (Slam dunk)
- Given above, the next 2 cPFS and PFS endpoints maybe serve a different purpose. Maybe they are to bridge the change in SOC, a way to validate for the patient, the change from how SOC efficacy is measured today (measuring tumor shrinkage) to the future way of DCVax and immunotherapies where it is a healthy, long process of managing disease (initial tumor size slightly increasing is good, systemic response, immune memory, long tail survival, equals cure).
I think that all the endpoints will need to be evaluated because they are part of the official SAP, but I think they stand independently, each can succeed or fail on their own merits. Why US website only has the 2 main endpoints, don't know but my gut says there is a reason to be revealed, and all 6 will eventually show up.
I agree on the UCLA combination trials using DCVax as the SOC and Keytruda as the add-on being tested, leads in the direction of doctors using DCVax off-label more and without chemo / radiation.
Here's my layman's thinking,
- OS is gold standard. Meeting the primary and first secondary endpoints is for NWBO to get what it wants, regulatory approval to market DCVax-L for the indications and labels of rGBM and ndGBM. (Slam dunk)
- Given above, the next 2 cPFS and PFS endpoints maybe serve a different purpose. Maybe they are to bridge the change in SOC, a way to validate for the patient, the change from how SOC efficacy is measured today (measuring tumor shrinkage) to the future way of DCVax and immunotherapies where it is a healthy, long process of managing disease (initial tumor size slightly increasing is good, systemic response, immune memory, long tail survival, equals cure).
I think that all the endpoints will need to be evaluated because they are part of the official SAP, but I think they stand independently, each can succeed or fail on their own merits. Why US website only has the 2 main endpoints, don't know but my gut says there is a reason to be revealed, and all 6 will eventually show up.
I agree on the UCLA combination trials using DCVax as the SOC and Keytruda as the add-on being tested, leads in the direction of doctors using DCVax off-label more and without chemo / radiation.
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
