Clinical Trial Design And Statistical PowerPhase III LEVEL remains highly powered to detect a meaningful change in six-minute walk distance, and lower-than-expected variability in patient responses strengthens confidence in the trial’s ability to demonstrate a true treatment effect.
Intellectual Property And Commercial ProtectionThe European Patent Office's intention to grant a patent covering levosimendan for PH-HFpEF supports potential market exclusivity and extends protection through 2040, enhancing long-term commercial prospects.
Open-label Patient-reported BenefitAnecdotal reports from the open-label extension indicate patients felt substantially better after re-initiation of oral levosimendan, suggesting a potential reduction in symptom burden for PH-HFpEF patients.