Historically you’re better off obtaining FDA or EMA approval given the size of their markets and the ‘authority’ that comes with those organisations. I can imagine JP lining up the ducks and communicating with potential partners to hit the ground running when FDA approval comes through. If you were to go to China as an example, without FDA approval you’d most likely have to perform another Phase 3 trial if you go the long route for Chinese approval which can take a very long time (3-5 years. Having FDA approval in hand would shorten the time to EMA approval as well.
Historically you’re better off obtaining FDA or EMA approval...
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