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Re: Vaffan-Coulo post# 12706

Saturday, 03/21/2015 1:18:29 PM

Saturday, March 21, 2015 1:18:29 PM

Post# of 14303
Not yet but the balance-sheet is kosher (if I may say so, because it is an Israeli Company)

Of importance:

At least they have the CE Mark
to be marketed and sold in 32 countries across Europe as well as in certain other countries worldwide. On March 5, 2014, MDSS, our


European Authorized Representative, completed the registration of the Dario™ Smart Meter with the German Authority as required by Article


10 of Directive 98/79/EC on in vitro diagnostic medical devices. We are currently pursing regulatory approval for Dario™ in the United States


and are expecting to receive clearance from the U.S. Food and Drug Administration on our 510(k) application by mid 2015.^

Going through the CE Mark process is time consuming and before you do not have it you cannot negotiate deals. I would say, as soon as they get their clearance from the FDA the market will know what to Price in.
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