I can't remember if I read it or was told, but FDA will need two trials from separate locations. EMA have told IXC what they want in the trial, now IXC are just dotting the i's and crossing the t's to make sure the EU trial will tick the box for one of the required FDA trials.
This way they only do two trials and not three.
IMO the EU one will be run first.
Ann: Invex Granted Type C Meeting with FDA, page-99
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