Ampio Pharmaceuticals Inc (AMPE)

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Michael Macaluso, Ampio's CEO, explained: "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."