RE:RE:RE:RE:RE:RE:Type C Meeting TimingsONCY has earlier stated that they submitted a "compelling" brief, that happens to be documentation that suffficiently supports the purpose of the requested meeting, which in ONCY's case is to guide a discussion with the FDA to align on the design and objectives of the registrational trial for pelareorep in breast cancer.
One could surmise that based on what ONCY has stated, the alignment with the FDA will be on the use of clinically identified biomarkers and conventional surrogate endpoints of ORR, PFS and OS to drive the accelerated approval of pelareorep in an expanded HER2 failed breast cancer population of patients, that includes all patients from early stage to late stage metastatic breast cancer, who have failed both estrogen and ADC therapy, and where a significant "unmet treatment need" exists.
By moving into the expanded treatment of breast cancer with pelareorep, such a strategy would open up the breast cancer market to pelareorep and set the stage for pelareorep to be subsequently used in combination with ADC and immune checkpoint inhibition in synergistic triplet combination therapies, that is highly more effective than when therapies are used as a monotherapy, as is currently the practice.