Sunday, August 10, 2025 7:06:41 AM
And again, that is 1-2 month after FINAL submission of a rolling review process.,
Per the FDA, and not an AI mash up:
The CMC section, which foir a biologic is the most complicated, will be the last section NWBO has as they already have the rest.
So again, once NWBO is ready, they will presubmit the CMC (and whatever else they want) then 60 days later the final that starts the clock. So 4 months.
I am not sure if it is the math or the concept that is so difficult for you.
EDIT: Not that it matters. There is a reason NWBO has not applied. And it is not because they are waiting for a voucher they have no chance in hell of getting.
Per the FDA, and not an AI mash up:
To qualify, sponsors must submit the chemistry, manufacturing, and controls (CMC) portion of the application and the draft labeling at least 60 days before submitting the final application.
The CMC section, which foir a biologic is the most complicated, will be the last section NWBO has as they already have the rest.
So again, once NWBO is ready, they will presubmit the CMC (and whatever else they want) then 60 days later the final that starts the clock. So 4 months.
I am not sure if it is the math or the concept that is so difficult for you.
EDIT: Not that it matters. There is a reason NWBO has not applied. And it is not because they are waiting for a voucher they have no chance in hell of getting.
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
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- Form POS AM - Post-Effective amendments for registration statement • Edgar (US Regulatory) • 04/16/2026 09:25:30 PM
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- 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
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- 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
