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Posted On: 03/19/2021 3:22:34 PM
Post# of 145247
"Some say if we applied for EUA and we get EUA, the 140 critical trial extention would be cancelled. Who would volunteer with the possibility of placebo?
Others say the 140 trial would continue, we need the data for "Full Approval"? "
The FDA has a Moderna trial on children going on right now, they basically can design a trial as they wish even if approved. My personal feeling, the whole placebo arm of a trial is real stupid in critical, they could just take numbers from those who died and use those percentages, even use similar hospitals, similar treatments. If LL is going to be used worldwide, wouldn't you want to compare it an average of let's 500,000 patients who died.
Others say the 140 trial would continue, we need the data for "Full Approval"? "
The FDA has a Moderna trial on children going on right now, they basically can design a trial as they wish even if approved. My personal feeling, the whole placebo arm of a trial is real stupid in critical, they could just take numbers from those who died and use those percentages, even use similar hospitals, similar treatments. If LL is going to be used worldwide, wouldn't you want to compare it an average of let's 500,000 patients who died.
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