Wednesday, July 14, 2021 10:56:54 AM
I am a long on NWBO, and as much as I would like to see the PIII trial succeed, I am not at all clear how the reclassification would change anything for the trial. By this I mean, If the trial originally include group A and group B as the intended treatment group, and if say the trial failed (or was not dispositive in result), when considering both groups as originally intended, then I seriously question that by incorporating a new generally accepted DEFINITION of GBM that now excludes group A from the definition (but not the trial) and that now the trial succeeds when ONLY considering group B and EXCLUDING the originally intended group A, that this would now constitute a successful trial that warrants FDA approval.
Frankly I can see both sides of the argument, and do not see this as a slam dunk for the trial based on this reclassification. I hope I am wrong, but I see this as debatable and can see the FDA going either way.
Frankly I can see both sides of the argument, and do not see this as a slam dunk for the trial based on this reclassification. I hope I am wrong, but I see this as debatable and can see the FDA going either way.
Recent NWBO News
- 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 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
