Tuesday, August 05, 2025 12:25:39 PM
Very true, and the frustration is understandable. But rules are rules, and that cuts both ways. NWBO is not required to announce an FDA submission unless it chooses to. And based on everything currently available, they have not broken any.
Submitting to the FDA, even under a new program like the Commissioner’s National Priority Voucher, is not automatically considered a material event. The company is allowed to submit confidentially, and unless they selectively disclose that information to someone else, there is no obligation to PR it. That is not “quiet period” spin. It is simply how Regulation FD and SEC reporting rules work.
If the submission is accepted, approved, or otherwise acknowledged in a way the company deems material to shareholders, then they must disclose it. Until then, silence is legally permitted. The same applies to Project Orbis, PIP, and other regulatory channels. These often progress quietly until formal milestones are met.
The company has said, believe nothing until you hear it from us. That applies in both directions. No news is not confirmation or denial. It is just no official news.
Submitting to the FDA, even under a new program like the Commissioner’s National Priority Voucher, is not automatically considered a material event. The company is allowed to submit confidentially, and unless they selectively disclose that information to someone else, there is no obligation to PR it. That is not “quiet period” spin. It is simply how Regulation FD and SEC reporting rules work.
If the submission is accepted, approved, or otherwise acknowledged in a way the company deems material to shareholders, then they must disclose it. Until then, silence is legally permitted. The same applies to Project Orbis, PIP, and other regulatory channels. These often progress quietly until formal milestones are met.
The company has said, believe nothing until you hear it from us. That applies in both directions. No news is not confirmation or denial. It is just no official news.
Bullish
Recent NWBO News
- How Advanced Drug Delivery Could Improve Existing Cancer Treatments • GlobeNewswire Inc. • 06/01/2026 12:30:00 PM
- CNS Drug Delivery Breakthroughs Unlock Significant Biotech Market Opportunities • InvestorsHub NewsWire • 05/11/2026 01:00:00 PM
- CNS Drug Delivery Breakthroughs Unlock Significant Biotech Market Opportunities • GlobeNewswire Inc. • 05/11/2026 12:30:00 PM
- Northwest Biotherapeutics Appoints Dr. Annalisa Jenkins As Strategic Adviser To Advance Dendritic Cell Cancer Vaccine Platform • PR Newswire (US) • 04/30/2026 04:38:00 PM
- Northwest Biotherapeutics Appoints Dr. Annalisa Jenkins As Strategic Adviser To Advance Dendritic Cell Cancer Vaccine Platform • PR Newswire (US) • 04/30/2026 04:30:00 PM
- Northwest Biotherapeutics Announces Establishment Of the Company's Own Dedicated Leukapheresis Clinic • PR Newswire (US) • 04/21/2026 01:30:00 PM
- 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
