Cytodyn Inc (CYDY): I'll also add that the additional ask re...

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Re: BlackDoggie post# 18097

Friday, 11/10/2017 11:37:33 AM

Friday, November 10, 2017 11:37:33 AM

I'll also add that the additional ask regarding patients for safety data may appear out of line with that reasoning at first blush. However, if I'm the FDA, and I'm agreeing to consider labeling more broadly than for a very small subset of very sick patients, I might want more safety data to justify it. Basically, if the company wants to market the drug (via the combo application) to a patient population that is less gravely ill than the patients they were originally restricted to, then the FDA might reasonably want more assurance that the drug is safe to offer to patients who may have options.

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Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 05/06/2024 09:17:30 PM
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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
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Form 8-K - Current report • Edgar (US Regulatory) • 01/29/2024 01:40:14 PM
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