It would seem to me that PAA did the smart thing and got the ODD moving, knowing that the FDA would later require the further data, which of course wasn't ready yet at the time of lodging the ODD! Seems to me that management should be getting credit for the smart move of lodging the ODD and getting it going, knowing that a little 'top-up' with the further data is better than starting an application after that data is finally available sometime in Q1.
It would seem to me that PAA did the smart thing and got the ODD...
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