BioCryst Completes Type C Meeting Regarding IV Peramivir

Loading...
Loading...
BioCryst Pharmaceuticals, Inc.
BCRX
today announced that it has completed its Type C meeting regarding intravenous (i.v.) peramivir with the U.S. Food & Drug Administration (FDA) and has received final meeting minutes. The minutes of the meeting were consistent with the FDA's preliminary comment letter, which was previously referenced in the Company's press release of April 1, 2013. In addition, the meeting minutes confirmed that BioCryst's proposed peramivir New Drug Application (NDA) content supports a reviewable NDA submission for the indication of acute uncomplicated influenza. In accordance with FDA's recommendation, the Company is in the process of requesting a pre-NDA meeting to reach agreement on a complete NDA submission and to address review issues
See full press release
Market News and Data brought to you by Benzinga APIs
Posted In: NewsGuidanceContractsGlobal
Benzinga simplifies the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.

Join Now: Free!

Loading...