Cytodyn Inc (CYDY): A BLA is submitted after an investi...

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Re: Saltz post# 57643

Thursday, 02/27/2020 1:07:37 PM

Thursday, February 27, 2020 1:07:37 PM

A BLA is submitted after an investigational new drug has been approved. If the Form 356h is missing information, the FDA will reply within 74 days. A BLA asserts that the product is "safe, pure, and potent", the manufacturing facilities are inspectable, and each package of the product bears the license number.

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Recent CYDY News

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 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

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