The way the FDA is going to look at it is that in
Post# of 148177
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Posted On: 03/30/2021 7:54:42 AM
Re: mountaineer #84672
The way the FDA is going to look at it is that in such a small population size the wider difference in mortality seen at 14 days may just be chance. So that won't be persuasive to the FDA in regards to an EUA.
It may add to the argument with the FDA about dosing but that leronlimab has a faster bioavailability with IV and that doses should cover the entire length of the trial is a stronger argument. Which I'm sure was the argument made when we tried to get it for CD12.
It may add to the argument with the FDA about dosing but that leronlimab has a faster bioavailability with IV and that doses should cover the entire length of the trial is a stronger argument. Which I'm sure was the argument made when we tried to get it for CD12.
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