BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced that it received a preliminary comment letter from the U.S. Food & Drug Administration (FDA) that outlines a pathway by which BioCryst could file a New Drug Application (NDA) seeking regulatory approval of intravenous (i.v.) peramivir. The letter was sent in response to questions BioCryst submitted to the FDA in advance of an upcoming Type C regulatory meeting regarding i.v. peramivir. The FDA also suggested the Company request a pre-NDA meeting to reach agreement on a complete NDA submission and to address review issues identified in its preliminary comment letter.