Do you believe that the FDA is doing a good job of negotiating through the combination or hybrid products?

Mann:

It’s not easy, and the restrictions imposed by law don’t always help. The agency faces some limitations, and although it’s not simple, they’re attempting to accelerate the process. I had a discussion with Janet Woodcock [FDA deputy commissioner for operations] a few weeks ago. They have a program now where they’re trying to make a real difference in accelerating the approval process, on the basis of more modern science, rather than the tenets that were in place thirty or forty years ago, when these regulatory processes were initiated."