Hey Guys, just got a question re: approvals. I'm wondering that if/when we get FDA for the adult app, do we then need to reapply for TGA, CE and FDA for the infant app assuming positive trial results or does the adult app cover us for the infant app also?
Also, guessing a rough timeframe for FDA for the infant app- would we apply for all 3 (TGA, CE and FDA) for infant app at the same time?- in which case would we be looking at maybe end of 2020 to potentially have all 3 approvals for both adult and infant apps?- or is that a bit ambitious?
Apologies if already covered, just curious.
Whiteox.
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