Sunday, March 24, 2024 11:18:33 PM
Zadie, I believe what you're saying is true, but I also believe I heard that when it comes to biological products there are requirements that they be made in the US. If this is the case, the Sawston facility couldn't be qualified for US commercial production. That would mean that if a substantial manufacturing facility had to operate manually, a very expensive facility would have to be built either by the company, or a contractor, presumably CRL. Individual clean rooms are dramatically more expensive than large cleanrooms that can house many EDEN units. I believe the Memphis CRL facility is already able to make some DCVax-L manually, but not in numbers required to be considered for commercial production. They can probably handle many EDEN units without further expansion. Other CRL facilities are very probably well suited to taking on some EDEN units if necessary.
I don't believe that either NWBO nor CRL want to go to the expense of building manual cleanrooms so commercial operations can start a few months prior to producing with the EDEN. If I'm wrong about biological products needing to be made here, then perhaps Sawston could do the job, but I suspect very few batches of vaccine would reach our shores unless they greatly enlarge the Sawston facility. We know the company intends to prove the EDEN units in Sawston, I really don't see them building a whole lot more tiny manual production clean rooms there.
Gary
I don't believe that either NWBO nor CRL want to go to the expense of building manual cleanrooms so commercial operations can start a few months prior to producing with the EDEN. If I'm wrong about biological products needing to be made here, then perhaps Sawston could do the job, but I suspect very few batches of vaccine would reach our shores unless they greatly enlarge the Sawston facility. We know the company intends to prove the EDEN units in Sawston, I really don't see them building a whole lot more tiny manual production clean rooms there.
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
