Thursday, January 31, 2019 5:40:03 PM
In other words, NWBO beleives the FDA was wrong so rubbing their face in it before they say "May I sell this drug" may not be the wisest decision. Now what could the FDA have been wrong about?
Hypothetically
FDA: "Looks like there is earlier progression in the DCVAX ARM"
NWBO: "It's not "progression", it is immune activated swelling, exactly what we want to see, here look at these other images"
FDA: "Well we haven't quite looked at images like that before so progression is still progression"
NWBO: "You win for now, everyone from here on out will get the drug and we will wait an exceptionally long time so that we can provide proof without a doubt that this was not true progression and also some of the true progression patients also improved once the VAX got warmed up. The vaccine will show that there is improved survival and these will not be estimations it will be actual proof. Since one of the inputs we use to estimate future survival is progression, and this is in contention, this will muddy our estimates, so we will have to wait all patients have been in the study for 3+ years."
just spit balling.
Hypothetically
FDA: "Looks like there is earlier progression in the DCVAX ARM"
NWBO: "It's not "progression", it is immune activated swelling, exactly what we want to see, here look at these other images"
FDA: "Well we haven't quite looked at images like that before so progression is still progression"
NWBO: "You win for now, everyone from here on out will get the drug and we will wait an exceptionally long time so that we can provide proof without a doubt that this was not true progression and also some of the true progression patients also improved once the VAX got warmed up. The vaccine will show that there is improved survival and these will not be estimations it will be actual proof. Since one of the inputs we use to estimate future survival is progression, and this is in contention, this will muddy our estimates, so we will have to wait all patients have been in the study for 3+ years."
just spit balling.
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
