They don't really have the right to do that, ... In a nutshell, no one had ever refused their demand to hire a consultant. And so I suppose we insulted them, and their response was, 'OK, if you're not going to do what we tell you to do, we're going to shut you down.' .

216

My guess is the government has spent at least that much themselves, ... and there have been literally hundreds of FDA people involved in this over a four-year period of time.

144

I have to say I'm not pleased with the ordeal that the FDA put us through and the waste of resources on both sides, ... We bent over backwards in a very respectful and diligent way to communicate, but they shunned all of our attempts to constructively resolve our disagreement.

132