This is an accelerated approval based on ORR (17%) and duration of response in the single-arm KEYNOTE-224 study. Patients were either refractory to, or ineligible for, Sutent, or had Child-Pugh-A cirrhosis. Today is the PDUFA date.
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”