The company's only option is to go off shore, if Andy can pull that
together. To sit around waiting for a revelation from the FDA is
not going to happen.
Try selling it in the UK and EU first, then if that is profitable
and doing well, bring it back to the US on and if FDA approved.
Any sales BIEL does off shore is taxed when the money is brought back into the US.
Andy's caught with no money to really push things forward in a fast
way. He messed up long ago. The window of opportunity has passed IMO.