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Monday, April 19, 2021 2:39:22 PM
I do not think even the Philippines will give an EUA without a trial that shows P value and an acceptance from our FDA. We have all read how the FDA insists it is just still just an investigational, the only thing that will budge this in their minds is an approval, even an EUA but nothing less from another FDA.
April 19, 2021 6:05am EDT
Clinical trial in U.S. for critically ill COVID-19 patients expected to initiate soon
CytoDyn in discussions with Brazil to initiate two COVID-19 trials, one for severe and one for critically ill patients
This is from the Headline on the press release from Cytodyn on the CMC module for the Canadian IO application.
The best hope is for a quick enrollment for the trials in Brazil. Also would hope that the US FDA accepts the trial data from Brazil.
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