There's a high degree of confidence in the results of the Phase 2 trial based on the experiences of the people treated under the EIND process. If you HAD to bet on it one way or the other, where would you put your money?
In the fortunate situation that the experimental arm is shown to be undeniably superior to the control arm the DMC may recommend termination of the trial. This would allow the company sponsoring the trial to get regulatory approval earlier and to allow the superior treatment to get to the patient population earlier. There are cautions here though. The statistical evidence needs to be very high indeed.[citation needed] Also, there might be other reasons to continue, such as collecting more long-term safety data. <<<
If the committee lives up to its responsibilty, leronlimab should be a cinch to get FDA approval.
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