Informative video. Thank you for the link.
I wasn’t aware that with fast track designation, Alterity is allowed to make an incomplete application for accelerated approval and are allowed to add more data on a “rolling” basis with feedback.
Very different from the standard where you only get one submission with all data needed at that point.
This would definitely change the timeline here. I imagine application could have been made and they’re waiting on the open study mid year results to come in and submit additional
supporting data to reinforce their position to get drug to market from these existing trials only.
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