Wednesday, August 31, 2022 5:08:01 PM
Thanks, I will stick with my theory. I know you indicated you have some regulatory experience with getting medical devices approved. But, when it comes to getting new biologics approved to treat oncology / cancer patients, I will stick with Dr. Pazdur's knowledge and experience.
I believe you are overestimating how difficult and challenging it will be for other non-EU countries like: Japan, Israel, Australia, Switzerland, etc. to approve DCVax-L, after the DCVax-L journal article is released, and after DCVax-L has been approved by regulatory authorities in the US, UK, Canada, Germany and the rest of the EU.
You are also overestimating how much time it will take for NWBio to get those other ROW approvals. NWBio will be able to use the exact same DCVax-L Phase III clinical trial results to apply for other regulatory approvals around the world.
I believe you are overestimating how difficult and challenging it will be for other non-EU countries like: Japan, Israel, Australia, Switzerland, etc. to approve DCVax-L, after the DCVax-L journal article is released, and after DCVax-L has been approved by regulatory authorities in the US, UK, Canada, Germany and the rest of the EU.
You are also overestimating how much time it will take for NWBio to get those other ROW approvals. NWBio will be able to use the exact same DCVax-L Phase III clinical trial results to apply for other regulatory approvals around the world.
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
