Friday, June 20, 2025 8:42:05 PM
Mani, I agree, but in reality, I don't believe management has provided any indication they're doing something, like the agreement with Roswell, then suddenly it's happened.
The one time they announced something prematurely it was an intent to file for approval with the UK, and then they had to revise their timing a couple times. No company I've ever followed has predicted when a regulator would act. If it was the FDA, a PDUFA date was set, but no statement until the FDA did something official.
Frankly NWBO has less control than many because they rely on contractors for so much that they do. I'm guessing that if they receive a RFI that a contractor will be involved in the answer, and perhaps be largely responsible for it. Most companies are bigger and while contractors might be involved, they'd have the lead, I don't think it's necessarily the case with NWBO though they certainly play a part.
It's impossible to say if everything is in the hands of the regulators today, or if NWBO still owes them information before they can proceed further. Once the regulator is satisfied, they'll make a decision, if not, they may ask additional questions and no telling how much more time will be added. Hopefully there are no more questions.
Gary
The one time they announced something prematurely it was an intent to file for approval with the UK, and then they had to revise their timing a couple times. No company I've ever followed has predicted when a regulator would act. If it was the FDA, a PDUFA date was set, but no statement until the FDA did something official.
Frankly NWBO has less control than many because they rely on contractors for so much that they do. I'm guessing that if they receive a RFI that a contractor will be involved in the answer, and perhaps be largely responsible for it. Most companies are bigger and while contractors might be involved, they'd have the lead, I don't think it's necessarily the case with NWBO though they certainly play a part.
It's impossible to say if everything is in the hands of the regulators today, or if NWBO still owes them information before they can proceed further. Once the regulator is satisfied, they'll make a decision, if not, they may ask additional questions and no telling how much more time will be added. Hopefully there are no more questions.
Gary
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
