Cytodyn Inc (CYDY): This was my understanding as well....

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Re: BlackDoggie post# 38076

Monday, 03/04/2019 9:28:49 AM

Monday, March 04, 2019 9:28:49 AM

This was my understanding as well.

CYDY previously announced that the FDA would permit rolling submission. In other words, CYDY could submit the BLA in pieces, but the FDA would only review the BLA once CYDY submitted the full BLA.

I take this morning's PR to mean that the FDA has, in addition to permitting rolling submission, told CYDY that it will review portions of the BLA as it is submitted.

If correct, this is obviously helpful to CYDY, because it should shorten the overall time to approval.

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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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