Cumberland Pharmaceuticals Inc. (CPIX) Discusses Duchenne Cardiomyopathy NDA Submission and Product Development Strategy Prepared Remarks Transcript

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A. KazimiFounder, Chairman, President & CEOGood afternoon, everyone. My name is A.J. Kazimi, and I'm Chief Executive Officer at Cumberland Pharmaceuticals, and I'm also joined by Dr. Ines Macias-Perez, Vice President, Product Development, who manages our clinical and regulatory activities. Today, we're issuing a press release providing an update on our product development activities, which can be found on our corporate website. We'd now like to share that update with you through this presentation.We appreciate this opportunity to introduce you to the new strategy for our company. And I'd like to start with a question. Investors may ask why Cumberland why now? Well, first, we have significant value creation opportunities. Our lead program in Duchenne muscular dystrophy is advancing towards a new drug application and behind it are multiple Phase II programs built on the same core molecule.Second, we are targeting attractive markets in which the addressable patient populations have limited or no effective treatment options. In Duchenne cardiomyopathy, for example, there is no approved therapy today.Third, we have compelling Phase II data in Duchenne, a dose-dependent improvement in heart function with a 5.4 percentage point difference in ejection fraction versus control corroborated by biomarkers.And fourth, we now have a defined path to an NDA. Today, I'm pleased to announce that we held a pre-NDA meeting with the FDA this fall. And given the urgent medical need, we've decided to proceed with the submission of an NDA for this program. And after the pre-NDA meeting with FDA, they granted our request for a rolling submission of the NDA.Next, we have an established safety