Friday, May 22, 2026 11:05:44 AM
But it could apply to NWBO's choice of a "company" in the US under the US manufacturing section of the10Q
I was just about to post this, so I'll do it in response to your post.
From the 10Q:
Manufacturing in the US – DCVax Products and Kalinski aDC1 Products.
The Company has been pursuing separate parallel tracks to develop manufacturing in the US of the Company’s DCVax-L products and of the aDC1 products pursuant to the technologies of Dr. Kalinski that the Company has in-licensed. For the production of DCVax-L products, during the first quarter the Company completed the selection of a US company, contract negotiations and entered into a technology transfer agreement for development of DCVax-L manufacturing capacity by the US company. The Standard Operating Procedures (SOPs) used in the UK are being adapted to the US facilities and operations, and training began during the first quarter. The Company anticipates that the required engineering runs and validations will be completed during the summer.
So again, we see a referene to NWBO choosing a separate company to work with manufacturing DCVax-L, this time in the US. It looks like they are already well ahead. Training personnel began in the first quarter of 2026 and they expect engineering runs and validations to be completed this summer.
I should note that manufacturing will likely start as compassionate care, which means patients will have to pay for treatment. It also means that the facility can only be in a state that has passed a law allowing compassionate care by drugs not approved yet by the FDA.
By contrast, NWBO says
For the production of Kalinski aDC1 products, the Company is working primarily to develop its own GMP manufacturing operation in the US, although it is also in discussions with a contractor for such production as an alternative. The Company has been in ongoing negotiations since last year to secure lease arrangements for a suitable GMP facility. In the meantime, during the first quarter the Company completed the lengthy recruitment process and hired the key manager to lead the aDC1 manufacturing operations.
Recent NWBO News
- How Advanced Drug Delivery Could Improve Existing Cancer Treatments • GlobeNewswire Inc. • 06/01/2026 12:30:00 PM
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- 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
