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di4

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Alias Born 12/16/2006

di4

Re: milkdud617 post# 952

Tuesday, 09/15/2015 3:26:45 PM

Tuesday, September 15, 2015 3:26:45 PM

Post# of 37328
4 total FDA submissions/pending clearance expected? Nice DD milkdud

One additional test for Staph ID/ Resistance was submitted to the FDA on August 31, 2015 and management expects a second test that will be submitted to the FDA by the end of September. The FDA typically will act on submissions within 90 days of receipt. Management expects that both tests will be FDA-cleared by year-end 2015. As the menu expands, the revenue per customer will expand, which is a key metric for the company. Moreover, two additional tests will be submitted to the FDA in Q4 2015 and the Company expects those will be FDA cleared by mid-2016.

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