I think BO offers could come way sooner than anyone here thinks. It doesn't take much of a leap of faith to see that this will work in humans like it does in animals. This could be a huge revenue driver for a large player in the marketplace today. They may want to take control sooner and cheaper to get this through the FDA's human trials process faster leveraging their capabilities and connects.
I believe the trial has to be included with the IDE submission. I remember reading about how the Mayo docs were working on the clinical study documents and that would be part of the IDE submission.
News 
Market Data 
Discover 
