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Posted On: 11/11/2021 3:32:14 AM
Post# of 154914
Amarex Timing -- help requested
I'm wondering if someone has a good handle on when Amarex did what.
On April 2, 2020, this article appeared:
"Amarex, an NSF International Company, Executes Five Rush COVID-19 Related Submissions to the FDA" -- "The submissions include an IND, IND Amendment and Compassionate Use Approval for CytoDyn’s product Leronlimab..."
Three of the five rushed Covid submissions to the FDA were for Cydy. It's my sense that all these submissions must have happened after the terribly lax HIV BLA submissions that the FDA ripped apart in its response. Is that correct?
Thanks in advance. Trying to figure out if Amarex can simply say that they were overworked and understaffed instead of incompetent/malevolent. I'm really not sure, but fear the worst.
I'm wondering if someone has a good handle on when Amarex did what.
On April 2, 2020, this article appeared:
"Amarex, an NSF International Company, Executes Five Rush COVID-19 Related Submissions to the FDA" -- "The submissions include an IND, IND Amendment and Compassionate Use Approval for CytoDyn’s product Leronlimab..."
Three of the five rushed Covid submissions to the FDA were for Cydy. It's my sense that all these submissions must have happened after the terribly lax HIV BLA submissions that the FDA ripped apart in its response. Is that correct?
Thanks in advance. Trying to figure out if Amarex can simply say that they were overworked and understaffed instead of incompetent/malevolent. I'm really not sure, but fear the worst.
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