Cytodyn Inc (CYDY): They self reported. Clinical trial SAEs...

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Re: HyGro post# 199874

Monday, 01/10/2022 5:23:23 PM

Monday, January 10, 2022 5:23:23 PM

They self reported. Clinical trial SAEs would be reported to the FDA by the company on a Medwatch report and linked to the IND. Most would be expected to be reported within 15 days. Deaths within 5 days. They are typically reported irrespective of causality. SUSARs would be followed more closely, typically would require an update to the IND and confirmation that the investigators and their staff are aware of the unexpected and related SAE.

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