This is an accelerated approval based on ORR (15%; 95% CI: [0.07-0.26]) and duration of response (67%>=6m) in a single-arm trial of 58 patients. (There was one complete response.)
FDA approvals of a new agent for any kind of sarcoma are pretty rare. The stock is flat in AH trading, so apparently this approval was considered a fait accompli.
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”
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