There has been a drop in the number of FDA approvals. While the decrease could be due to many factors, the rate of delays in meeting review deadlines has risen from 4 percent to 11 percent.
I'm really disappointed that Auricle didn't submit sooner. I wish I understood better why they didn't. I'm afraid that when they finally do submit, the approval process will take longer, and the FDA will have an even larger backlog of applications to work through.