Monday, August 18, 2025 9:45:00 AM
Given your MHRA FOI reply I’m now convinced the MHRA is not waiting for the new ECA guideline to be formally published before deciding on DCVax-L. Your FOI response makes it clear: approval can be granted on scientific merit alone, without a finalized guideline in place.
That said, it’s still plausible they are reviewing the consultation feedback to make sure no serious objections were raised that could undermine their position. NWBO highlighted in the last 10-Q that they worked with doctors, patients, academics, and politicians to shape the submissions, which suggests they see this process as directly relevant to their case.
In practical terms, that means the decision doesn’t hinge on the official publication date of the guideline. Instead, timing depends on how quickly MHRA digests the feedback and feels comfortable moving forward. That could still stretch the review by weeks or a few months, lets say this autumn.
That said, it’s still plausible they are reviewing the consultation feedback to make sure no serious objections were raised that could undermine their position. NWBO highlighted in the last 10-Q that they worked with doctors, patients, academics, and politicians to shape the submissions, which suggests they see this process as directly relevant to their case.
In practical terms, that means the decision doesn’t hinge on the official publication date of the guideline. Instead, timing depends on how quickly MHRA digests the feedback and feels comfortable moving forward. That could still stretch the review by weeks or a few months, lets say this autumn.
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
