@Domesticgod,
My opinion has changed since last week.
The FDA is not requiring the trial be done in adults. I believe the Company still has the choice to run a trial in adults or children. The Company has chosen adults, not because of an FDA requirement, but because some consider it unethical to run a placebo-controlled trial in children. I'll let the ethicists debate that point. The whole foundation of RCT's is that it's ethical to run a trial when a medication remains "unproven".... because that's the only way to prove it. Note especially that proof of a reduction in mortality in an RCT requires.... higher mortality in the control arm. How else can you prove there's been a reduction?
CEO Itescu needs to go, page-42
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