I wonder if a breakthrough therapy application will go to the FDA in relation to PM. As Jon said the results well exceeded their expectations.
BT is designed to expediate development of drugs "intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s)"
https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/breakthrough-therapy
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