Sunday, November 15, 2020 12:32:10 PM
The trial itself will take 6-9 months if they get the right # of enrollees. -IFthe results show sufficient efficacy to submit to the FDA, the FDA will scrutinize it closely and most likely ( given the history of sloppines in earlier submissions) will send it back with questions. That's another few months. CYDY will then answer the questions if they can, and send it off to the FDA for a second try.
Since the FDA is scurrying to review many submissions, CYDY will have to wait in line before they even open the manila envelope.
So maybe close to a year before anyone knows whether it 1) does show required efficacy 2) gets approval or not.
Meanwhile 122 companies around the world are forging ahead with their trials .
Of course if it doesn't meet standards, it'll never get submitted at all. The result will be " Good by CYDY! The worry is all over .
Since the FDA is scurrying to review many submissions, CYDY will have to wait in line before they even open the manila envelope.
So maybe close to a year before anyone knows whether it 1) does show required efficacy 2) gets approval or not.
Meanwhile 122 companies around the world are forging ahead with their trials .
Of course if it doesn't meet standards, it'll never get submitted at all. The result will be " Good by CYDY! The worry is all over .
Recent CYDY News
- 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
- Form 8-K - Current report • Edgar (US Regulatory) • 03/05/2026 01:35:02 PM
- CytoDyn Closes $17.5 Million Financing to Fund Continued Development of Leronlimab • GlobeNewswire Inc. • 03/05/2026 01:30:00 PM
- CytoDyn Presents Novel CCR5 Inhibition Mechanisms and Long-Term Survival Signals for Leronlimab in Metastatic Breast Cancer at AACR Immuno-Oncology Conference • GlobeNewswire Inc. • 02/20/2026 01:30:00 PM
- CytoDyn Announces Funding and Initiation of Expanded Access Program for Patients with Triple-negative Breast Cancer • GlobeNewswire Inc. • 01/27/2026 01:30:00 PM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 01/09/2026 10:15:22 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 01/09/2026 01:30:45 PM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 12/22/2025 10:15:23 PM
- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 12/17/2025 05:15:14 AM
- December 2025 Letter to Shareholders • GlobeNewswire Inc. • 12/16/2025 01:30:00 PM
