Cytodyn Inc (CYDY): There still is a PDUFA review for this a...

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Re: SmileyRiley_595 post# 81799

Tuesday, 06/02/2020 11:01:20 AM

Tuesday, June 02, 2020 11:01:20 AM

There still is a PDUFA review for this application. It has not been approved. Cytodyn has asked for priority review, which hopefully will speed up the process, but it's not approved.

https://www.nuventra.com/resources/blog/regulatory-differences-between-an-nda-bla/

To formally request approval to market a new drug in the United States, sponsors must submit either a New Drug Application (NDA) or a Biologics License Application (BLA) to the FDA. As their names suggest, BLAs relate to biological products while NDAs generally pertain to traditional small molecule drugs.

Not approved yet! Yet...

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Recent CYDY News

Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 09/13/2024 04:15:06 AM
Form POS AM - Post-Effective amendments for registration statement • Edgar (US Regulatory) • 09/07/2024 12:44:56 AM
Form S-1 - General form for registration of securities under the Securities Act of 1933 • Edgar (US Regulatory) • 09/07/2024 12:42:22 AM
Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 08/15/2024 09:21:30 PM
Form SC TO-I/A - Tender offer statement by Issuer: [Amend] • Edgar (US Regulatory) • 07/22/2024 01:00:58 PM
Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 07/09/2024 09:17:48 PM
Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 07/09/2024 09:16:28 PM
Form SC TO-I/A - Tender offer statement by Issuer: [Amend] • Edgar (US Regulatory) • 07/09/2024 09:16:25 PM
Form 8-K - Current report • Edgar (US Regulatory) • 07/09/2024 12:46:25 PM
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 3 - Initial statement of beneficial ownership of securities • Edgar (US Regulatory) • 02/16/2024 02:00:24 AM
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Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 01/29/2024 10:22:17 PM

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