Here's a statement from the CEO in the 3Q Earnings report that was issued in November:
“As previously announced, we submitted a 510(k) premarket submission with the U.S. Food and Drug Administration (FDA) for the MAGO® 4S, our next-generation fully automated Enzyme-linked Immunosorbent Assay (ELISA) system for autoimmune and infectious disease testing. We believe the new instrumentation will provide a flexible, efficient and cost-effective solution to today’s high-performance laboratory demands. We filed this 510(k) submission on September 30, 2009, which was well in advance of our previously announced goal of making that submission prior to year-end. We have received feedback from the FDA requesting that we provide additional analytics and clinical test data, and are working with them to provide the requested information and expedite the approval process. We remain hopeful that we can achieve our previously announced goal of receiving regulatory approval during the first quarter of 2010 and, in any event, expect to receive regulatory approval during the first half of 2010,” Dr. Struby continued.
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