Financial PositionCadrenal ended the quarter with $7.3 million, which is highlighted as a significant concern, as additional funding will be necessary to support ongoing operations.
Funding RisksNext steps involve submitting a full study design synopsis and additional justification for key design elements to the FDA, with the anticipation that the Phase 3 TECH-LVAD trial could begin by YE25, assuming necessary funding is secured.
Regulatory ChallengesThe 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.