"reasonably likely to predict" accelerated approval program accelerated approval program http://www.fda.gov/ForPatients/Approvals/Fast/ucm405447.htm accelerated approval Accelerated Approval accelerated approval program accelerated approval accelerated approval www.fda.gov/ForPatients/Approvals/Fast/ucm405447.htm accelerated approval accelerated approval program accelerated approval accelerated approval program accelerated approval accelerated approval accelerated approval accelerated approval accelerated approval accelerated approval program accelerated approval accelerated approval Accelerated Approval program. accelerated approval accelerated approval www.fda.gov/ForPatients/Approvals/Fast/ucm405447.htm accelerated approval “accelerated approval”