Looking closely at the ARTH statement, ARTH said little that is definite (or potentially actionable) about the current business. Once a CE mark is issued for AC5, packaging and package insert with the issued CE mark number and approved text for the package leaflet must be printed in the language of all countries in which the product will be distributed. Then product & packaging/leaflet must be assembled. Is AC5 the brand name? One must hope that product that was manufactured many months ago is not becoming short shelf life dated. Then what? Still nothing happening in the US, essentially 10 months after FDA premakret clearance. So, what's next???
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