“Following a recent Type A meeting with the FDA, and receipt of the meeting minutes, we believe we have aligned on a path forward for the information needed to resubmit the BLA with Fujifilm as our drug substance manufacturer,” said Matt Pauls, chair and CEO, Savara (SVRA). “With the Process Performance Qualification campaigns now complete at Fujifilm, and finalization of the analytical data package expected early in the fourth quarter, we plan to resubmit the BLA in December. We are grateful for the constructive and timely dialogue with the FDA and are pleased to be working with Fujifilm, a top 10 biologics manufacturer with more than 20 approved drug substances globally and a successful inspection history with numerous regulatory authorities.”
Elevate Your Investing Strategy:
- Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence.