“We pursued a broad package of comorbidity data in both the initial package and now in subsequent data that will read out over the coming year.”

In context

“David Ricks (Chair and Chief Executive Officer): Yes. Thanks, Courtney. As you mentioned, we've been pursuing this for a little while because we believe retatrutide is a biologic application, both in terms of amino acid count rule as well as analogous to a protein. So that's our position. There was a mixed decision in the first decision in the court. Obviously, it's an active litigation, but we would hope to come to a conclusion with the FDA to support a BLA application. As you may know, we have announced at the end of our clinical program that we have all the clinical data we need to submit, but we do need to gather a little bit more on the CMC side. While that's going on, you can bet we're in communication with the agency, and we'll give an update to investors as there's any progress on the filing status for retatrutide. We're seeing really unprecedented efficacy with this triple-acting GLP-1. We have a pretty large lead over any competitors with a triple-acting medicine. We pursued a broad package of comorbidity data in both the initial package and now in subsequent data that will read out over the coming year. So very excited about the program and look forward to the submission by Q1 next year.”