Chromatics Color Sciences International. Inc; CCSI Message Board

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Biotech / Medical : Chromatics Color Sciences International. Inc; CCSI

CCSI 22.38

-4.8%

Nov 14 3:59 PM EST

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To: BuzzVA who wrote (4626)	9/16/1998 11:56:00 AM
From: Jeffrey L. Henken	Read Replies (1) of 5736

The first step was FDA approval. That was of course achieved well over a year ago. If it was CCSI's intention to manufacture and distribute the device in the USA and then in Europe we would have heard something along those lines by now. Of course those who are short on the stock will tell you there is not enough cash to do any such thing and they would be right. In my opinion CCSI is still pursuing manufacturing and distribution deals for this product here and abroad. In the US we need an ISO 9000 certified product to manufacture the device. In Europe we need the device itself to receive CE Mark. What will CE Mark do for the product? The CE Mark certification allows the company, and it's partner when one is named, to market the device within the 15 countries that comprise the European Economic Community (EEC). Under the European Union Medical Devices Directive, all devices sold onto the market since June 14 (ie. not already in the distribution chain) must bear the CE Mark. So the next logical step is to announce a manufacturing partner. If you are long you hope this will happen soon. InvestRight Regards, Jeff

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