On August 26, 2021, Avenue Therapeutics, Inc. received an Appeal Denied Letter from the Office of Neuroscience of the FDA in Response to its Formal Dispute Resolution Request submitted in July 2021 with respect to the Complete Response Letters previously issued by the FDA to Avenue related to its intravenous (“IV”) tramadol New Drug Application. The regulatory history of the NDA for IV tramadol, the anticipated FDRR process and other pertinent information regarding these topics were previously disclosed.