RE:FDA "Project FrontRunner" - to advance accelerated approvalsWhat is important to consider is that ONCY's Phase 2 BRACELET-1 study will provide readings on the surrogate endpoints outlined in the following excerpted paragraph .... and by doing so could potentially be approved under the Project FrontRunner initiative on the condition that ONCY have the FDA move pelareorep from Fast Track designation into the accelerated approval pathway based simply on the results obtained from the randomized BRACELET-1 Phase 2 study. "The accelerated approval pathway allows drugmakers to start selling medicines based on trials that show improvements in surrogate endpoints. In oncologys case, those endpoints include tumor response rate and disease progression, rather than the gold standard of proof, which is a cancer drugs ability to help people live longer. In many cases, this early data come from a single-arm trial without an active comparator."