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© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Comments
Loading...
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!
Already a member?Sign in