Wednesday, May 08, 2024 10:02:25 AM
No mention of accelerated approval, but they could be sitting on that maybe.
FDA guidance recommends that confirmatory trials be underway at the time an accelerated approval is granted. But since guidance does not carry the force of law or regulation, the FDA has limited leverage to ensure the trials are initiated at that time
FDA guidance recommends that confirmatory trials be underway at the time an accelerated approval is granted. But since guidance does not carry the force of law or regulation, the FDA has limited leverage to ensure the trials are initiated at that time
Recent CVM News
- Form RW - Registration Withdrawal Request • Edgar (US Regulatory) • 05/27/2026 09:00:36 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/18/2026 12:03:20 PM
- CEL-SCI Reports Fiscal Second Quarter 2026 Results • Business Wire • 05/18/2026 12:00:00 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/15/2026 09:00:50 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/14/2026 09:16:25 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/13/2026 08:44:06 PM
- CEL-SCI Announces Closing of Public Offering • Business Wire • 05/13/2026 07:00:00 PM
- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 05/12/2026 04:15:05 AM
- CEL-SCI Corporation Announces Pricing of Public Offering • Business Wire • 05/12/2026 12:11:00 AM
- CEL-SCI Enters Strategic Agreement with Amarox for the Registration, Commercialization, and Distribution of Multikine in Saudi Arabia • Business Wire • 05/11/2026 12:00:00 PM
- Form S-1 - General form for registration of securities under the Securities Act of 1933 • Edgar (US Regulatory) • 04/17/2026 09:07:27 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 04/01/2026 11:03:27 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 04/01/2026 10:59:38 AM
- CEL-SCI Reports Fiscal First Quarter 2026 Results • Business Wire • 02/18/2026 02:00:00 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 02/17/2026 10:01:19 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/26/2026 01:23:27 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/05/2026 02:30:02 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/05/2026 02:26:57 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/05/2026 02:23:02 PM
- CEL-SCI Reports Fiscal 2025 Results • Business Wire • 12/29/2025 02:00:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 12/05/2025 01:48:04 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/24/2025 10:00:37 PM
