RE:RE:RE:RE:RE:RE:RE:PwC sees continuation of US$ 5 to 15 Billion Bio M&A DealsWith two Phase 2 clinical trials completed, in metastatic breast cancer, namely IND-213 and Bracelet-1, and a PFS, ORR and mOS reported in Bracelet-1 of 38.2%, 37.5% and a near doubling in median overall survival, respectively, ONCY is the closest to an Accelerated Approval than any other agent in this category of immunomodulators.
Mature overall survival (OS) from the Bracelet-1 study is expected at anytime.which supports an Accelerated Approval request, now that ONCY has guided on a planned adaptive 180-200 patient Phase 2b/ Phase 3/confirmatory clinical trial, that can morph from one Phase to another as an adaptive design provides, and which ONCY is able to conduct on its own.