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Tuesday, November 03, 2020 1:20:18 AM
It will be interesting to see the dosing regimen approved by the FDA.
We know Brilacidin has a long half life with a short time to virolysis.It also is effective in vitro at low doses. Will the FDA opt for 1,2 or 3 infusions or 2 arms with different doses?
My guess is 2 different doses given 2 or 3 infusions 2-3 days apart.
Fortunately they have experienced researchers to work these matters out.
What will the end points be? The in patient study most likely will evaluate treatment in hospitalized patients on low levels of oxygen without signs of imminent pulmonary failure.
If you are really confident the first end point will be lower mortality[ which no antiviral drug has achieved]if not time to recovery second will be reduced percentage to pulmonary failure or shorten tim oxygen was required and the last will be time to virus neutralization in hospitalized patients .
We should have more details of the human clinical trials in 2-3 weeks. The trial will be short.
For comparison review the Remdesvir Adaptive Covid-19 Treatment Trial (ACTT-1)trial:
https://www.nejm.org/doi/full/10.1056/NEJMoa2007764
GLTA Farrell
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