Quote “ CytoDyn expects to enroll patients in
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Posted On: 04/01/2020 6:10:00 AM
Quote
“ CytoDyn expects to enroll patients in both the Mild-to-Moderately Ill and Severely Ill protocols very quickly under the same IND that was provided with a “safe to proceed” letter from the FDA. The new protocol for Severely Ill COVID-19 patients is for 342 patients, double blinded with 2:1 ratio. Patients enrolled in this trial are expected to be administered leronlimab for two weeks with the primary endpoint being the mortality rate at 14 days.”
So does that mean it’s already approved when they say “.. under the same IND that was provided with a “safe to proceed” letter from the FDA”
“ CytoDyn expects to enroll patients in both the Mild-to-Moderately Ill and Severely Ill protocols very quickly under the same IND that was provided with a “safe to proceed” letter from the FDA. The new protocol for Severely Ill COVID-19 patients is for 342 patients, double blinded with 2:1 ratio. Patients enrolled in this trial are expected to be administered leronlimab for two weeks with the primary endpoint being the mortality rate at 14 days.”
So does that mean it’s already approved when they say “.. under the same IND that was provided with a “safe to proceed” letter from the FDA”
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