Ampio has received an initial response from the FDA, Office of Tissue and Advanced Therapies division regarding the company's submission of a proposed trial design for the treatment of KL4 Osteoarthritis patients with Ampion. The trial design includes concurrent controls and would be carried out under a Special Protocol Assessment. Ampio's CEO Michael Macaluso stated: "A SPA is an agreement between the sponsor and FDA that the trial design, clinical endpoints, and statistical analyses could support marketing approval. The recently received FDA correspondence included guidance and questions that require a response from Ampio, which is routine under these circumstances. We are preparing our response to their comments that will include additional questions to allow maximum clarity. We will provide an update as soon as this process is completed."