It's tough to know what exactly is necessary to be granted a...

It's tough to know what exactly is necessary to be granted a Breakthrough Device (or Therapy for drugs) Designation because the FDA does not make public their reasonings for granting the designations. In my experiences following small to micro cap companies hoping to get the designation for devices or drugs I've found that it takes more data/time than investors expect.

I know that's a vague comment but it's seemed to hold true. One thing I do know from following a small pharma that applied too early and got rejected is that filing prematurely irritates the FDA because it wastes their time (the CEO called it strike one against them with the FDA). I'm confident that Wayne and his team will discuss any plans for a submission with the FDA well before they actual do it so they can file at the proper time.