Cytodyn Inc (CYDY): They have success on a 510k application...

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Cytodyn Inc (CYDY)

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Re: 3X Charm post# 183416

Monday, 09/13/2021 12:01:24 AM

Monday, September 13, 2021 12:01:24 AM

They have success on a 510k application on a device. 100 pages maybe.

BLA - 500,000 pages. Infinitely more complex and requires regulatory specialists which Cytodyn has hired and looking for a clinical specialist .

You do realize that Nader and Kelly don't do this sort of work themselves. They hire people such as Recknor to know the mechanics of the process and manage it. They then hire the appropriate specialist to do the real work.

Yeah , no thanks, let the ECOR guys merge their wonderful company with InCellDx and they can all live happy together.

Has Bruce Patterson received any FDA approvals ? Even a 510K ?

I'm pretty sure he has not shepherded a BLA.

Jmo

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Recent CYDY News

Form 8-K - Current report • Edgar (US Regulatory) • 06/03/2024 09:15:10 PM
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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
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