Richard Burr: “Any concern by you or any of your colleagues here today whether the $800 million threshold can be met?”

I always like to bring things back to the present because I have a tremendous amount of respect for all four of you.

The FDA failed to do its job, plain and simple.

It is time that we hold the FDA accountable.

The faster, more predictable, and more accountable the programs are, the more patients stand to benefit from lifesaving, innovative drugs and devices.