Wednesday, January 22, 2025 6:40:16 AM
NWBO recognized that PFS didn't work as an end point a decade ago soon after the trial started and they saw tumors increase in size initially due to the infiltration of immune systems cells killing the cancer that was being mistook for tumor Progression vs PFS.(Progression Free Survival).
The trial end point shifted to overall survival and to compare to other external trial data mainly because much of the placebo control group they lost or was corrupted by the crossover provision where they could crossover after Progression so Overall Survival would be altered (bettered due to DCVAX)
The modification to the endpoints where made before any trial data was visible to them.
By itself, an endpoint modification is not problematic because a clinical trial is a coalescence of ideas and midstream changes. However, a noted change in and of itself raises a perception of bias in an active trial that is open and accruing and even more so in a trial that has completed accrual.
By itself, an endpoint modification is not problematic because a clinical trial is a coalescence of ideas and midstream changes. However, a noted change in and of itself raises a perception of bias in an active trial that is open and accruing and even more so in a trial that has completed accrual.
Men who are occupied in the restoration of health to other men, by the joint exertion of skill and humanity, are above all the great of the earth. They even partake of divinity, since to preserve and renew is almost as noble as to create.
Recent NWBO News
- 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 EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 11/26/2025 05:15:34 AM
- 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
- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 03/31/2025 09:23:24 PM
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