We believe it would likely take two years or more

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We believe it would likely take two years or more to conduct the studies and trials necessary to obtain approval from the FDA to commercially launch the PCa Test.

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We already have two clinical studies that will be submitted with the 501(K). Most likely excessive caution after getting slapped on the wrist for using boilerplate warnings in past SEC filings.
https://www.globenewswire.com/news-release/20...-Test.html

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In addition, as previously reported in our Form 8-K filed August 14, 2019, the chairman of our audit committee resigned from the Board of Directors effective August 12, 2019. As a result, as of the date of this annual report, our audit committee no longer had a “financial expert” as defined by applicable SEC requirements. We are currently attempting to identify additional qualified individuals who are independent, and who have sufficient experience in finance and accounting to satisfy the definition of an audit committee “financial expert.”

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It once again could be over-cautiousness after his employer's (New Age Beverage) disaster in acquiring Morinda. The overvaluation of Morinda should have been caught by anyone looking at their books.