“I'm thinking that the FDA and CytoDyn could agr
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Posted On: 10/18/2020 6:52:59 PM
Re: chuckles759 #61830
“I'm thinking that the FDA and CytoDyn could agree to have the CTAP program super accelerate the HIV BLA approval that's already in progress and then use Leronlimab as "off-label" for COVID but tied with a Phase 4 to ensure there's safety related to COVID application.”
If the data from the S/C interim analysis is strong enough to warrant CTAP recommending the HIV BLA be expedited to make leronlimab available for off-label COVID19 prescriptions, then the DSMC would simply recommend halting the trial and CYDY would apply for EUA. The off-label route via HIV approval is a LONG path if the efficacy is evident.
If the data from the S/C interim analysis is strong enough to warrant CTAP recommending the HIV BLA be expedited to make leronlimab available for off-label COVID19 prescriptions, then the DSMC would simply recommend halting the trial and CYDY would apply for EUA. The off-label route via HIV approval is a LONG path if the efficacy is evident.
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