“The Company also confirms the U.S. FDA has rece
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Posted On: 03/06/2021 9:12:24 PM
“The Company also confirms the U.S. FDA has received its protocol for enrolling 140 critically ill COVID-19 patients with the primary endpoint defined as length of hospital stay.”
This is very promising. It’s not an immediate EUA, but I imagine CYDY can enroll this trial quickly, finish it within a few months, and get an EUA based on data. Reducing length of stay is a much easier endpoint than mortality,
The path forward in the UK and Canada is less clear, but it looks likely they want more data. If they don’t give some type of approval based on OLE data, they will give approval on the 140 patient trial results.
This is very promising. It’s not an immediate EUA, but I imagine CYDY can enroll this trial quickly, finish it within a few months, and get an EUA based on data. Reducing length of stay is a much easier endpoint than mortality,
The path forward in the UK and Canada is less clear, but it looks likely they want more data. If they don’t give some type of approval based on OLE data, they will give approval on the 140 patient trial results.
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