”Internationally” could be anywhere, but the focus of Triangle Insights report was US so makes sense trial is Is based.
Remember manufacture is in EUR so is RC220 not EMA cGMP clearance so not US FDA equivalent. Perhaps we see a CTA approval and trial rather than US IND.
Also it primed the US sites for rollout of P2!
I favour US cGMP clearance is being obtained with the bulk of the Tox studies along with some of the consultants on the ground in the US rather than EUR.
IND before Australian ethics?, page-8
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