Trial approved to proceed after midpoint DSMC check, no changes proposed by DSMC at midpoint review, FDA resumes eIND approvals for severe-critical patients while awaiting data from Phase 3 trial, FDA approved administration of Leronlimab to new severe-critical patients via Open Label Extension protocol while awaiting Phase 3 data, FDA kept both eINDs and OLE in place even after receiving the Phase 3 trial data. These 5 points are the very definition of complete success.
5 out of 5. Impossible to do better than that.
MABs from established Big Pharma companies haven’t gotten the same results.
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