Saturday, May 28, 2022 10:56:29 AM
In a perfect world, we would have the dataset of a double-blind placebo test comparing OS (overall survival). Unfortunately, this is not feasible for a few reasons:
-Since untreated GBM has a 100% fatality rate, it would be unethical to deny someone access to a non-toxic treatment that might actually save their life.
-Does the FDA really need to wait another 7 years for the trial to be redone just so they can get a slightly cleaner-looking set of data points? The difference with DCVax is pronounced, and the therapeutic is clearly saving lives. Do another 50,000 people need to die of GBM so we can get a slightly better looking survival curve? If the treatment had chemo-style side effects, I could see a point in this, but DCVax is also NON-TOXIC so there is really nothing to lose from a patient's point of view.
-Since untreated GBM has a 100% fatality rate, it would be unethical to deny someone access to a non-toxic treatment that might actually save their life.
-Does the FDA really need to wait another 7 years for the trial to be redone just so they can get a slightly cleaner-looking set of data points? The difference with DCVax is pronounced, and the therapeutic is clearly saving lives. Do another 50,000 people need to die of GBM so we can get a slightly better looking survival curve? If the treatment had chemo-style side effects, I could see a point in this, but DCVax is also NON-TOXIC so there is really nothing to lose from a patient's point of view.
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
