BioCryst Pharmaceuticals, Inc. today announced that it received a preliminary comment letter from the U.S. Food & Drug Administration that outlines a pathway by which BioCryst could file a New Drug Application seeking regulatory approval of intravenous peramivir.
http://www.benzinga.com/news/13/04/3459999/biocryst-pharma-issues-update-related-to-peramivir-says-fda-suggests-pre-nda-meet
http://www.benzinga.com/news/13/04/3459999/biocryst-pharma-issues-update-related-to-peramivir-says-fda-suggests-pre-nda-meet
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