They were part of the new class created by the FDA. Their products are up to code. Only BIEL asked for OTC clearance which is a big thing. Ten months later and this product is down the toilet, with the PPS of this stock. Dreamers think minor league Keith is a difference maker, but they are just dreamers, nothing more. This process is obviously harder to accomplish than us outsiders understand, but if they can't get ir done, they should sell company with a big royalty to the owners, and give us long time shareholders what we deserve for keeping the canoe upright ! This is just a sad sad situation. If we don't have great news by April, we never will !! Semper Fi AW...GET IR DONE ASAP !!!!!!!!!!!!!