| Followers | 200 |
| Posts | 25596 |
| Boards Moderated | 0 |
| Alias Born | 04/03/2010 |
Saturday, January 29, 2022 7:27:57 PM
They would not be told the randomization was otherwise. It would of course still go through the DSMB.
The answer makes no sense, the randomization is exact. They do not just end up with missing arms. His answer can be heard a lot of different ways. People heard it the way they heard it because they believed and still believe certain things. But we won't know until we and they know.
When for instance, the DSMB might be required to eliminate an arm, let's say for an ethical reason but not yet to break the blind, they can still "randomize" to another arm, it's just that neither are placebo. The company was blind all the way through, so there is NO WAY they an know anything specific about the randomization and of course they are going to continue saying that is the case, because as long as they were concerned, IT WAS.
Of course the FDA was involved in the HOLD. As I said, if ANY regulator places a hold, the FDA is immediately and automatically involved and the trial comes to a halt. But the original halt is still applicable as you can see from the very website that confirmed the change to the end points. The FDA's hold was not necessarily the CAUSE. Different issue than who was involved.
The answer makes no sense, the randomization is exact. They do not just end up with missing arms. His answer can be heard a lot of different ways. People heard it the way they heard it because they believed and still believe certain things. But we won't know until we and they know.
When for instance, the DSMB might be required to eliminate an arm, let's say for an ethical reason but not yet to break the blind, they can still "randomize" to another arm, it's just that neither are placebo. The company was blind all the way through, so there is NO WAY they an know anything specific about the randomization and of course they are going to continue saying that is the case, because as long as they were concerned, IT WAS.
Of course the FDA was involved in the HOLD. As I said, if ANY regulator places a hold, the FDA is immediately and automatically involved and the trial comes to a halt. But the original halt is still applicable as you can see from the very website that confirmed the change to the end points. The FDA's hold was not necessarily the CAUSE. Different issue than who was involved.
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
