Monday, January 09, 2023 11:21:47 AM
That’s a reasonable suggestion flipper, but it’s been my observation that, while Dave serves a valuable purpose, he’s been unable to answer seemingly immaterial questions in a direct manner, so I haven’t talked with him in a couple years. In this case, it could reveal a commercialization strategy.
I thought that Northwest Bio was planning a slow (go-it alone) commercialization rollout only in the UK this year to work out the commercialization kinks, and then later next year expand to the US. Using fresh monocytes, and regional manufacturing would be fine for this type of commercial startup. However, if Linda is taking about global distribution, and redundant manufacturing, possibly implying a much larger commercial rollout, (potentially with a strategic partner say for Project Orbis) then cryopreserving leukapheresis material would absolutely be necessary. Let’s hope that Advent has been working on this since before I first raised the issue in 2021.
By the way, the first approved CAR-T manufacturers (Kite & Novartis) both cryopreserved their leukapheresis material early in clinical trial development, in recognition of the eventual logistical necessity for global distribution.
I thought that Northwest Bio was planning a slow (go-it alone) commercialization rollout only in the UK this year to work out the commercialization kinks, and then later next year expand to the US. Using fresh monocytes, and regional manufacturing would be fine for this type of commercial startup. However, if Linda is taking about global distribution, and redundant manufacturing, possibly implying a much larger commercial rollout, (potentially with a strategic partner say for Project Orbis) then cryopreserving leukapheresis material would absolutely be necessary. Let’s hope that Advent has been working on this since before I first raised the issue in 2021.
By the way, the first approved CAR-T manufacturers (Kite & Novartis) both cryopreserved their leukapheresis material early in clinical trial development, in recognition of the eventual logistical necessity for global distribution.
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
