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attilathehunt

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attilathehunt

Re: None

Thursday, 03/30/2017 1:22:38 PM

Thursday, March 30, 2017 1:22:38 PM

Post# of 18784
From the Form 6-K...

It appears they are confident in the approval...

Most importantly, the FDA specified the additional statistical analysis of existing data that would be required to further support the Company’s conclusions. The Company expects that it can provide those data in a compelling fashion and demonstrate that Macrilen™ is a robust, repeatable test, demonstrating adequate sensitivity and specificity and that the performance of the product would be improved by utilizing a more appropriate cut-off point.
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