Going forward if it isn’t allowed to add all the excellent data that was obtained after the MAA submittal and the prospect of approval looks unlikely would it make sense to withdraw the application then as rapidly as possible submit a new MAA incorporating all the data now in hand.
This sounds to be faster than waiting for the appeal process to play out over the next several months then still find ourselves at the start again stage.
Or at least put together a new MAA submittal and be ready to send it the moment a final turn down occurs.
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