Biotechmaster : .US Zulassung im 3Q / 4Q 2010..Unentdeckte Aktie
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IVAX Diagnostics (AMEX: IVD)
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Dr. Struby continued, ?Our efforts with respect to our 510(k) premarket submission filing with the U.S. Food and Drug Administration for the Mago® 4S, our next-generation fully automated ELISA system for autoimmune and infectious disease testing, are progressing, and we continue to expect to receive regulatory approval from the FDA and launch the product during the fourth quarter of 2010. Following the receipt of all required regulatory approvals and the subsequent commercial launch of the product, we expect the Mago® 4S will provide a flexible, efficient and cost-effective solution to high-performance laboratories, and will be our primary platform for marketing our kits in the U.S.?