Richard Burr: “If we can bring down that remand rate, there is no question that we can improve the timeliness of our decisionmaking…”

What does it mean for a small company when FDA misses these goals, and what does it mean to patients?

Are you beginning to see the pattern as to why a plan is important? This has been a well-orchestrated event up to this point.

I will continue to ask you for a plan until we get one, and I will continue to be a roadblock for those who believe that we can blindly just appropriate emergency money.

I question whether the agreements both passed and proposed reflect a good deal for patients they are designed to serve.