In The Face Of Significant Interest From Domestic And International Distributors, A Fortune 500 Company, Congressional Members And Inquiries From Media Outlets, The SEC’s Unilateral Action Is Counter-Intuitive In The Face Of The COVID-19 Pandemic
LOS ANGELES, CA / ACCESSWIRE / April 27, 2020 / Decision Diagnostics Corp. (OTC PINK:DECN) through its subsidiary Pharma Tech Solutions, Inc. the manufacturers and design specifiers for the :15 GenViro! Professional Swift Kit for testing Covid-19 testing, today discusses actions taken by the United States Securities and Exchange Commission (“SEC”) on April 23, 2020. Specifically, the SEC issued a release announcing the temporary suspension in the trading of securities of Decision Diagnostics (DECN) pursuant to Section 12(k) of The Securities Exchange Act of 1934. Section 12(k) authorizes the SEC to summarily and unilaterally suspend trading in any security for a period not to exceed ten (10) days. The suspension, which by its terms is scheduled to expire at 11:59 PM on May 7, 2020, stated it was based on questions regarding the accuracy and adequacy of certain information concerning DECN in the marketplace since at least March 3, 2020, which was some fifty-one (51) days before the suspension was issued.
Prior to the trading suspension Keith Berman, DECN’s CEO, had voluntarily submitted to over three hours of interviews conducted by SEC staff members over multiple days. At the conclusion of the second interview a third interview was requested by the staff. Instead the SEC suspended trading without warning or further discussion.
Despite the interim trading suspension, DECN, through its subsidiary Pharma Tech Solutions, Inc., intends to press its negotiations with the FDA for expedited approval of the company’s GenViro! Swift Kit for the testing of the Covid-19 virus. While the proposed testing kit would be new, and to the best of DECN’s knowledge, different than any other kit for which regulatory approval is now also being sought, the technology is fundamentally built on a platform designed by the company in 2018 to service diabetics. This product called GenUltimate! TBG has been offered by DECN in International markets since the Fall of 2019. DECN believes its core impedance technology, proven to provide enhanced accuracy in testing for diabetics, was quickly reengineered for Covid-19 testing and that upon final FDA approval may well result in inexpensive and easy to use test kits for the detection of Covid-19. In an effort to expedite the regulatory approval process DECN has initially only sought approval of its GenViro! Swift professional testing kits, designed to be used in various facilities. DECN shortly plans seeking FDA approval for the company’s at-home test kits, which it believes will be even easier to use, this time by individuals at-home and businesses wishing to test employees as part of their “back to work” plans. Both GenViro! kits employ the company’s impedance technology.
ABOUT DECISION DIAGNOSTICS CORP
Decision Diagnostics Corp. is the leading manufacturer and worldwide distributor of diabetic test strips engineered to operate on legacy glucose meters. DECN’s products are designed to operate efficiently and less expensively on certain glucose meters already in use by almost 7.5 million diabetics worldwide. With new inspired technology diabetic test strips already in the final stages of development, DECN products compete on a worldwide scale with legacy manufacturers currently selling to 71+ percent of a $15+ billion at-home testing market. The company’s new GenViro!TM product designed to test for the Coronavirus Covid-19, is not yet available in the United States or Puerto Rico but Emergency Waivers are in process. Prior and during the pendency of the FDA review, our product concept has been presented to officials in Washington, DC. Subsequently we have enlisted the support of a lobbyist and several members of the U.S. Congress.
This release contains the company’s forward-looking statements which are based on management’s current expectations and assumptions as of April 24, 2020, regarding the company’s business and performance, its prospects, current factors, the economy, and other future conditions and forecasts of future events, circumstances, and results.
SOURCE: Decision Diagnostics Corp.
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