Violations of federal securities laws as a result of a series of materially false statements. The Complaint accuses Defendants of violations of the Securities Exchange Act of 1934 by virtue of their failure to disclose, during the Class Period, that: (1) the APPY1 test failed to meet the criteria for "substantial equivalence" based upon data and information submitted by Venaxis in its 510(k) submission; (2) the Company lacked a reasonable basis to conclude that the results from the APPY1 pivotal study were sufficient to support Food and Drug Administration ("FDA") clearance; and (3) as a result of the foregoing, Venaxis' public statements pertaining to the expected FDA clearance of its 510(k) submission were materially false and misleading at all relevant times. According to the Complaint, Venaxis issued a press release on January 29, 2015 disclosing that the FDA had determined that the "APPY1 Test does not meet the criteria for substantial equivalence based upon data and information submitted by Venaxis in its 510(k) submission." According to the Complaint, following the Company's January 29, 2015 announcement, the value of Venaxis shares declined significantly. Filed in D. Col.
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