“Remdesivir gets emergency use authorization by
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Posted On: 05/01/2020 5:05:35 PM
“Remdesivir gets emergency use authorization by FDA.”
The good news for CYDY regarding Remdesivir’s emergency approval is that we now know the bar for approval isn’t very high.
At this point, all CYDY has to do is enroll the 75 patient mild/moderate trial and get 50 patients into the severe trial. I believe data from both of those trials, in addition to data from the EIND patients, will be undeniable. The problem is the snails pace of enrollment and the 6 weeks of data required for the mild/moderate trial. How did Gilead get primary endpoints of 14 days and we got 6 weeks?
The good news for CYDY regarding Remdesivir’s emergency approval is that we now know the bar for approval isn’t very high.
At this point, all CYDY has to do is enroll the 75 patient mild/moderate trial and get 50 patients into the severe trial. I believe data from both of those trials, in addition to data from the EIND patients, will be undeniable. The problem is the snails pace of enrollment and the 6 weeks of data required for the mild/moderate trial. How did Gilead get primary endpoints of 14 days and we got 6 weeks?
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