You miss the point! Empirical evidence cannot be o

You miss the point! Empirical evidence cannot be overlooked by the FDA!!
At this point the Biel technology is the tip of the iceberg for electroceutical device II approval and therefore the FDA needed to amend their own review and approval crtieria. This will impact opiod abuse by the way at the top of the obama health agenda and FDA has given Actipatch a comprehensive review.
ITS A DONE DEAL!