I agree that the objective in the severe/critical
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Posted On: 05/11/2020 4:24:12 PM
I agree that the objective in the severe/critical trial is to get to 50 (the sneak peek cohort size), not 390.
My guess is that 75 mild/mod and 50 sev/crit could happen by the same date. To my memory, both have 28 day mortality primary, 14 day secondary, endpoints.
Remember p-values depend both on the size of the effect and the square root of the sample size. With 50 patients, you need 2.8 times the effect size to get the same significance as with 390 patients. That could happen.
Given that, favorable trends in a related population (mild/mod), and a proven safety profile, an EUA would definitely be a possibility.
There is no conflict between RDV (virus-replication) and Leronlimab (cytokine problems). Fauci said he was looking for an inflammation-reducing mab for a cocktail with RDV. Both could be in the SOC (until everyone realizes which one is doing the work).
My guess is that 75 mild/mod and 50 sev/crit could happen by the same date. To my memory, both have 28 day mortality primary, 14 day secondary, endpoints.
Remember p-values depend both on the size of the effect and the square root of the sample size. With 50 patients, you need 2.8 times the effect size to get the same significance as with 390 patients. That could happen.
Given that, favorable trends in a related population (mild/mod), and a proven safety profile, an EUA would definitely be a possibility.
There is no conflict between RDV (virus-replication) and Leronlimab (cytokine problems). Fauci said he was looking for an inflammation-reducing mab for a cocktail with RDV. Both could be in the SOC (until everyone realizes which one is doing the work).
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