Cytodyn Inc (CYDY): HIV BLA: FDA 60-day vs. 74-day letter....

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Cytodyn Inc (CYDY)

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Monday, 06/22/2020 10:07:16 AM

Monday, June 22, 2020 10:07:16 AM

HIV BLA: FDA 60-day vs. 74-day letter.

We all understand that by July 11th, 74 days post the April 27th filing, the FDA will send a letter with the "PDUFA date" for the approval decision for use of leronlimab in HIV combo therapy.

Also note that if there is exceptionally good or bad news - a decision not to file, or a decision to move forward with a priority review - that is conveyed by day 60 - Saturday June 26th. It could be any day this week.

Chuckles - please confirm we read this the same.

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Recent CYDY News

Form 8-K - Current report • Edgar (US Regulatory) • 06/03/2024 09:15:10 PM
Form SC TO-I - Tender offer statement by Issuer • Edgar (US Regulatory) • 06/03/2024 09:10:56 PM
Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 05/06/2024 09:17:30 PM
Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 05/06/2024 09:16:24 PM
Form 8-K - Current report • Edgar (US Regulatory) • 05/06/2024 09:09:58 PM
Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/09/2024 02:30:20 AM
Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 03/01/2024 10:16:47 PM
Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 03/01/2024 10:15:34 PM
Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 02/22/2024 10:16:11 PM
Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 02/22/2024 05:15:08 AM
Form 3 - Initial statement of beneficial ownership of securities • Edgar (US Regulatory) • 02/16/2024 02:00:24 AM
Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend] • Edgar (US Regulatory) • 02/12/2024 10:31:57 PM
Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 01/29/2024 10:22:17 PM
Form 8-K - Current report • Edgar (US Regulatory) • 01/29/2024 01:40:14 PM
Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 01/19/2024 10:15:35 PM
Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 01/16/2024 10:16:04 PM
Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/06/2024 02:04:57 AM
Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/06/2024 02:04:20 AM
Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/06/2024 02:02:59 AM
Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/06/2024 02:02:30 AM

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