Thursday, September 17, 2020 4:46:59 PM
We seem a bit off. FDA website discusses Emergency Use Authorizations. These authorizations for Medical Countermeasures (MCMs) apply to drugs and other Biologics. The company can request an EUA from the FDA and the FDA has described a format and needed information to be submitted with the request. I do not know if there is some confusion over terminology re application vs request. But based on the FDA website there is a process to follow including asking for the designation and preparing supporting documentation.
As I listened to the call, I was confused by the cloudiness of the explanation given by NP. But my interpretation was that CytoDyn did not ask for the authorization.
As I listened to the call, I was confused by the cloudiness of the explanation given by NP. But my interpretation was that CytoDyn did not ask for the authorization.
Recent CYDY News
- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 05/21/2026 04:15:12 AM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 05/20/2026 09:08:39 PM
- CytoDyn to Present at the LD Micro Invitational XVI • GlobeNewswire Inc. • 05/15/2026 12:30:00 PM
- CNS Drug Delivery Breakthroughs Unlock Significant Biotech Market Opportunities • InvestorsHub NewsWire • 05/11/2026 01:00:00 PM
- CNS Drug Delivery Breakthroughs Unlock Significant Biotech Market Opportunities • GlobeNewswire Inc. • 05/11/2026 12:30:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 04/30/2026 08:32:50 PM
- CytoDyn Announces First Patient Dosed in Expanded Access Program for Leronlimab in Triple-Negative Breast Cancer • GlobeNewswire Inc. • 04/27/2026 12:30:00 PM
- CytoDyn to Host Investor Webcast • GlobeNewswire Inc. • 04/23/2026 12:30:00 PM
- Form S-1 - General form for registration of securities under the Securities Act of 1933 • Edgar (US Regulatory) • 04/22/2026 09:21:50 PM
- CytoDyn Presents New Leronlimab Data in Metastatic Colorectal Cancer at AACR Annual Meeting 2026 • GlobeNewswire Inc. • 04/22/2026 12:30:00 PM
- CytoDyn Completes Enrollment in Phase 2 Metastatic Colorectal Cancer Study • GlobeNewswire Inc. • 04/21/2026 08:10:00 PM
- CytoDyn Presents New Leronlimab Data in Metastatic Triple-Negative Breast Cancer at AACR Annual Meeting 2026 • GlobeNewswire Inc. • 04/20/2026 12:30:00 PM
- CytoDyn to Present at the AACR Annual Meeting 2026 • GlobeNewswire Inc. • 04/14/2026 12:30:00 PM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 04/08/2026 09:15:18 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 04/08/2026 12:30:28 PM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 03/25/2026 09:16:10 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/24/2026 09:24:23 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/24/2026 09:23:14 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/24/2026 09:22:42 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/24/2026 09:21:33 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/24/2026 09:20:57 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/24/2026 09:20:20 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 03/24/2026 09:15:24 PM
- CytoDyn Presents at AACR Special Conference in Cancer Research: Brain Cancer • GlobeNewswire Inc. • 03/24/2026 12:30:00 PM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 03/09/2026 09:15:18 PM
