Makena Sponsor Covis Seeks To Use FDA Officials’ Words, Actions On Accelerated Approval Against CDER

Company cites comments by Oncology Center of Excellence Director Richard Pazdur and Office of Neuroscience Director Billy Dunn on reasons why confirmatory trials fail and the need for regulatory flexibility. Ironically, both senior officials have publicly extracted commitments from companies to withdraw products if postmarketing trials do not verify clinical benefit.