One level of progression could be tagged as an SAE
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Posted On: 07/21/2020 8:09:57 AM
One level of progression could be tagged as an SAE.
The efficacy may be far superior to what is shown in SAEs. The FDA considers prolongation of hospitalization to be a serious adverse event. Someone could be admitted to the trial be administered leronlimab and advance one level in disease progression before leronlimab started kicking in heavy at day 3. Even if leronlimab then reversed it by several levels it would still be considered an SAE. We won't know exactly what the efficacy is until that data is released.
The efficacy may be far superior to what is shown in SAEs. The FDA considers prolongation of hospitalization to be a serious adverse event. Someone could be admitted to the trial be administered leronlimab and advance one level in disease progression before leronlimab started kicking in heavy at day 3. Even if leronlimab then reversed it by several levels it would still be considered an SAE. We won't know exactly what the efficacy is until that data is released.
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