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. |
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. |
The real damage to the company is that we had historically been an innovative company, bringing out products that have unique features, ... Our new product development has essentially been shut down for three years because of this. As far as our senior management goes, we've easily spent a third of our time over the last four years on this. |
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.' |