I dont see anything hinting at a deny ruling? Was it not that long ago when the FDA called Meridian for more info? FDA clearance is important to the effect that the US would be the biggest market but their sales seem to be going ok anyways. Looks like theyre just going to work around it for now. It is frustrating though.
So Long and thanks for all the fish.
He who smiles at lofty schemes, stems the tide of broken dreams. R.Hodgson