“April 3rd 2020 PR - CytoDyn Files a Clinica
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Posted On: 04/28/2021 5:12:09 PM
“April 3rd 2020 PR -
CytoDyn Files a Clinical Trial Protocol with the FDA to Treat Severely Ill COVID-19 Patients with Leronlimab where the Primary Endpoint is Mortality Rate at Two Weeks
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.”
The above confirms my point: CYDY didn’t have enough data to support the need for more than 2 doses and was excited about the reduction in mortality at 2 weeks in the first 5 or so EIND patients. Additionally, NP resubmitted the initial CD16 protocol with only 2 doses, perpetuating the problem until Amarex (C+ CRO) noticed a significant survival rate at 14 weeks in the 62 critical patients. Again, to place 100% of the blame on the FDA is inaccurate and requires one to ignore Amarex’s poor performance thus far (M2M design, BLA and cancer BTD with only 2 patients) and NP’s history.
CytoDyn Files a Clinical Trial Protocol with the FDA to Treat Severely Ill COVID-19 Patients with Leronlimab where the Primary Endpoint is Mortality Rate at Two Weeks
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.”
The above confirms my point: CYDY didn’t have enough data to support the need for more than 2 doses and was excited about the reduction in mortality at 2 weeks in the first 5 or so EIND patients. Additionally, NP resubmitted the initial CD16 protocol with only 2 doses, perpetuating the problem until Amarex (C+ CRO) noticed a significant survival rate at 14 weeks in the 62 critical patients. Again, to place 100% of the blame on the FDA is inaccurate and requires one to ignore Amarex’s poor performance thus far (M2M design, BLA and cancer BTD with only 2 patients) and NP’s history.
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