Meetings with the FDA provide guidance and feedback. These meetings are not characterized as "slam dunkish" or in any other emotional terms. The company asks about trial design, about how to present data and analysis, what pathways are open to pursue for approval and what each pathway requires, etc. Meetings are meant to ensure that planning is done properly and efficiently, and meant to understand and minimize risk. The FDA representatives come into meetings well-prepared and are extremely constructive. They want to help. For their part, Anavex would come well-prepared with questions and specific areas of concern they want guidance about. The meetings are not where decisions are made by the agency, they are guideposts or milestones on the way to approval.
Market Data 
Markets 
AI
