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Posted On: 09/22/2023 1:21:10 PM
Post# of 148870
There are a few things in the complaint filed in court against Amarex that could have drawn the FDA's ire. First, Amarex back-dated letters regarding their adherence to the monitoring plan.
Second, cutting Cytodyn off from the data capture after Amarex stopped their trial monitoring meant that Cytodyn would not have quick and easy access to notifications of serious adverse events, which must be reported to the FDA within 24 hours. Plus if there is a serious adverse event docs need to know if the patient is on the drug or placebo. So Amarex blocking access to the data capture could have put patients at risk.
Second, cutting Cytodyn off from the data capture after Amarex stopped their trial monitoring meant that Cytodyn would not have quick and easy access to notifications of serious adverse events, which must be reported to the FDA within 24 hours. Plus if there is a serious adverse event docs need to know if the patient is on the drug or placebo. So Amarex blocking access to the data capture could have put patients at risk.
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