Good points, however, to have come this far when the weight and the balance of FDA approval will be coming, and to not have anything lined up, it's a little hard to approve.
Seriously, it wouldn't matter which day or which year the FDA granted the OTC.
He had plenty of time to line something up, and to be 6 months down the road from the actual permission grant, and to still have nothing.
Well, it's clearly a mark against him.
It will happen eventually, but it should have been done at the outset.
Shaloam