Dont forget there is a lot at stake here .. These devices when 'approved' will revolutionize the entire Pain med field. Pain pills no matter what brand can go directly to the disposable area.. I think that's the reason. I think the FDA recognizes this importance. So a decission will be of enormous magnitude But after the green light uncharted territory.. Not wise in guessing but i think its going to be a ride to some space station far far away