News and Trends 15 Apr 2015
Heart Metabolics bargain with the FDA for a single Phase III
Heart Metabolics received an agreement letter from the FDA related to the company’s proposed phase III trial Special Protocol Assessment (SPA) request. The FDA has agreed to a single, randomized, pivotal Phase III trial of 350 patients evaluating perhexiline for the treatment of moderate-to-severe hypertrophic cardiomyopathy (HCM). The company, focused on the development of drugs […]