RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:Type C Meeting TimingsAnd my experience has shown me that the FDA has clearly outlined their path towards granting an accelerated approval when a study that compares the investigational drug to an available therapy (or placebo, if there is no available therapy) in clinical testing or from a study that compares the new treatment plus SOC to the SOC alone and clinical evidence indicating a substantial improvement over available therapies is demonstrated (as ONCY has done in the Bracelet-1 breast cancer study and in the Goblet-1. PDAC cohort study).
The FDA encourages sponsors to obtain some preliminary comparative data of the above type early in development, which ONCY has done in the IND-213, and AWARE-1 Phase1/2 breast cancer and biomarker clinical studies. Other types of clinical data that the FDA consideres persuasive include single-arm studies comparing the new treatment with well-documented historical experience, which ONCY has generated from its Bracelet-1 and Goblet-1 Phase 2 clinical studies in breast and pancreatic cancers.