RE:RE:ONCY's bought deal to support 2 Phase 3 studiesAdlai Nortye's US$85 million payment to ONCY is part of the negotiated licensing agreement for pelareorep in China and is triggered on the enrollment and treatment of the 50th patient in a Phase 3 breast cancer study.
Since the FDA will permit the patient data from the Phase 2 BRACELET-1 to be rolled into an adaptive ER+/Her2- mBC Phase 3 study, ONCY can roll data from 31 Bracelet-1 patients into the Phase 3 count, thus requiring ONCY to enroll 19 patients to total 50 patients and trigger Adlai Nortye's US$85 Million payment to ONCY.
The ability to include Bracelet-1 patients + 15 patients from Adlai Nortye's cross-over study should result in the $85 million payment being triggered as soon as ONCY files for the Phase 3 mBC study with the FDA. And this inturn should have the FDA granting an Accelerated Approval soon thereafter, given that patient enrollment in the Phase 3 would be sufficiently underway and would meet one of the FDA's requirements for an early approval.