Cytodyn Inc (CYDY): FDA changed how they would take submissi...

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Re: bluefish1 post# 211299

Friday, 07/01/2022 8:56:35 AM

Friday, July 01, 2022 8:56:35 AM

FDA changed how they would take submissions. They refused to take paper and would only take electronic. Amarex's website said they were ready for this change, but they must not have been. No sabotage. Just stubbornness and clash of personalities. Hopefully, the new CRO has a database that they know works with the FDA system. The reviewer even said that they could see the AEs in the data transfer files, but it wasn't populating into their database for review.

The worst that happens is that they do double data entry inhouse into a database like EPIC, do their validation of the data transfer and send a bill to Amarex.

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