You just don’t get it do you? You don’t want to get it.
As said by Drs Kurtzberg & Itescu, physicians would not ethically participate in such a trial, which includes use of a placebo, for children who are already dying (NOT at risk of dying, but dying.
Parents would not choose a trial where they know their child has an equal chance of a placebo over treatment, not when they are 100% guaranteed treatment through emergency use application.
I believe an FDA expert panel member at the ADCOMM meeting said that a RCT may not be feasible.
His reasoning is shared, it would now seem, by others in the FDA.
Be open to learning to doc.
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