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.
You just don’t get it do you? You don’t want to get it. As said...
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