BioCryst Pharmaceuticals announced that it has completed its Type C meeting regarding intravenous peramivir with the U.S. 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. In addition, the meeting minutes confirmed that BioCryst’s proposed peramivir New Drug Application 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 identified in the minutes. BioCryst anticipates that The Biomedical Advanced Research and Development Authority will schedule and hold its In-Process Review meeting in Q2 with the objective of determining the future for the underlying peramivir development contract.
- BioCryst Pharmaceuticals
- meeting minutes