RE:RE:RE:RE:RE:RE:RE:RE:RE:How does Accelerated Approval work note, my confusion regarding the accelerated approval timing revolves around the following:
Oncolytics Biotech® reports favorable results for BRACELET-1 breast cancer study reinforcing path to funding of a registration-enabling study. News release. Oncolytics Biotech, Inc. September 19, 2024.
followed by this definition:
Registration Enabling Trial means any Clinical Trial that is intended to, or does, generate data sufficient to enable the Filing of a Marketing Application in any country in the Territory. For clarity, a Registration-Enabling Trial may be a Phase 1 Trial, a Phase 2 Trial, or a Phase 3 Trial; provided, however, for any Clinical Trial other than a Phase 3 Trial, the determination of whether such Clinical Trial is a Registration-Enabling Trial shall be solely determined by the Filing of a Marketing Application for such Licensed Product after completion of such Clinical Trial. this seems to suggest that even though the two surrogate endpoints, pfs and mos, have been established, the above explanation of a registration enabling trial says it must be completed before filing a market application. however, with the surrogate endpoints established doesn't oncy still have to have at least some minimal enrollment with those newly enrolled patients evidencing achievement of pfs or mos to then get aa?
having trouble squaring that circle. since aa could be requested after a phase 1 or a phase 2 trial, why couldn't oncy have just made the request after the bracelet-1 study? bracelet-1 was a phase 2 trial.
really wanting this to happen sooner rather than later but it seems later is how it may shake out.
thanks for any clarification.