MARKJOHN I READ YOUR POST AND BURST OUT LAUGHING! IT MAKES NO SENSE AT ALL, BEEN SAYIN IT MONTHS BRO. BUT WE ALL KNOW THAT THE FDA IS SHADY/CROOKED ANYWAY, SO MAYBE THEY WANTED MORE LOOT FOR THE OTHER CLEARANCE.
This is a baseless reason bullying a small AMERICAN COMPANY and requiring them to do more. This is a brilliant example of over regulations. Without the opioids epidemic, BIEL WOULD HAVE BEEN STILL STRUGGLING TO GET CLEARANCE EVEN FOR FOOT AND KNEE.