indeed Topol's interview with Hahn touches on many
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Posted On: 10/15/2020 6:16:12 PM
indeed Topol's interview with Hahn touches on many aspects of the issues that the FDA is currently addressing with leronlimab.
"save a life", "pandemic", "may be effective", "risk-benefit ratio", "rationale behind an EUA" are all important, but probably not even half of what the FDA must resolve.
At this moment, the FDA does not have "pandemic protocol."
If Seethamraju's Oct 7 statement is factually correct, then the FDA's delberation of the CD12 results will become the de facto "pandemic protocol". Of course the leronlimab "pandemic protocol" may not survive the next-up therapeutic
Delay just seems likely because the FDA is now running the show and no doubt they want to get their leronlimab disposition correct, regardless if that disposition is EUA, continue the trial, or other.
"save a life", "pandemic", "may be effective", "risk-benefit ratio", "rationale behind an EUA" are all important, but probably not even half of what the FDA must resolve.
At this moment, the FDA does not have "pandemic protocol."
If Seethamraju's Oct 7 statement is factually correct, then the FDA's delberation of the CD12 results will become the de facto "pandemic protocol". Of course the leronlimab "pandemic protocol" may not survive the next-up therapeutic
Delay just seems likely because the FDA is now running the show and no doubt they want to get their leronlimab disposition correct, regardless if that disposition is EUA, continue the trial, or other.
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