Clinical Trial DesignThe FDA meeting led to an agreement that demonstrating superiority in the trial would not be feasible, leading to alignment on a non-inferiority design instead.
Manufacturing And Supply ChainCadrenal completed the technical transfer and manufacturing transition of tecarfarin’s drug substance from an Asia-based CDMO to one in the U.S., which should help support its clinical and regulatory development strategy and improve supply chain security.
Partnership And DevelopmentCadrenal announced a development agreement with Abbott to develop Tecarfarin in patients with Abbott’s HeartMate3 LVAD.