Instead, a spokesperson asserted that the Food and Drug Administration "supports expanded access programs that can provide patients with serious or life-threatening conditions access to investigational treatments when no comparable or satisfying approved therapies are available." "Each request is reviewed on a case-by-case basis based on the clinical circumstances and applicable statutory and regulatory requirements," the spokesperson added
Patient Perspective Both patients reported satisfaction with their outcomes and remained asymptomatic at follow-up
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Lastly, patients with heart failure (HF), composite cardiovascular events (i.e., unstable angina, ischemic heart disease, myocardial infarction, coronary stenting, percutaneous coronary intervention (PCI), coronary artery bypass), and clinically significant portal hypertension events (i.e., esophageal varices with and without bleeding, ascites, hepatic failure, hepatorenal syndrome, portal hypertension, liver transplant status, fibrosis, sclerosis and cirrhosis of the liver, hepatic encephalopathy, jaundice) were excluded if they occurred before inclusion to the cohort or prior to the index event
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