FDA would have told them to wait until Q3 to file rather than agree to Q1 filing that will hinge on HR<1 in June final readout. Third time's the charm Harry!
Today's FDA approval process is completely different from Padzur's biased-filled process resulting in 2013's CRO. It's a whole new game Harry and it's based on tolerability and PFS efficacy. You and your shorts will be learning the hard way.