RE;"LTC's Frank D'Amelio added, "We are presently moving from prototype to preproduction with our manufacturers here in the United States. As a result of this news we, will now be working with our Ukrainian and Russian distribution partners to assess their demand requirements and will fold their requirements and the timing thereof into a worldwide production schedule. Live Tissue Connect, Inc. (LTC) will continue to evaluate preproduction samples of both our disposable RF-sealing instruments and our bipolar generator, which are based on the aforementioned technology, in July / August 2007. Adding Russian and Ukrainian volume of these products to our production plan will also occur during this same period."
Would it not be possible and likely to have 2 production facilities, one for EU and the Russian Federation, and one for North America(U.S., Canada)? Since the original proto's were mfg. in Ukraine and as base of origination, established infra would indicate value existing going that way. Continuing
in that thread, would it not be a race to see the EU CE request via possibly the two fronts, rather than just FDA acceptance.
Follows that EU CE not nesessarily dependant on whats going on here. After all, why have to deal with import export issues going to the continent.