Richard Burr: “If we're not focused on outcome, then we've made a huge mistake.”

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.

More than 278 therapies have been approved under the accelerated approval pathway over the 30 year history, saving and improving thousands of lives.

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

The response was clear, FDA should be held accountable to its commitments.