According to the law firm press release, Atossa is a development-stage healthcare company. The Company is focused on the commercialization of cellular and molecular diagnostic risk assessment products and related services for the detection of pre-cancerous conditions that could lead to breast cancer.
The Complaint alleges that throughout the Class Period, Defendants made false and/or misleading statements, as well as failed to disclose material adverse facts about Atossa's business and financial condition. Specifically, Defendants made false and/or misleading statements and/or failed to disclose to Atossa investors that: (1) the Company was required, but failed, to submit an additional 510(k) notification to obtain necessary FDA clearance as it made material changes to the Nipple Aspirate Fluid specimen collection process; (2) the Company improperly marketed its devices by using certain promotional claims to market the ForeCYTE Breast Health Test and the MASCT device; (3) the Company was in violation of FDA Good Manufacturing Practices regulations; and (4) as a result of the foregoing, Atossa's statements were materially false and misleading at all relevant times.
On February 25, 2013, the Company disclosed that on February 21, 2013, it had received a warning letter from the U.S. Food and Drug Administration ("FDA") regarding its MASCT System and MASCT System Collection Test (together, the "System"). Specifically, in the warning letter, the FDA alleged that "the Company changed the System in a manner that requires submission of an additional 510(k) notification to the FDA" and the letter also raised "certain issues with respect to the Company's marketing of the System and the Company's compliance with FDA Good Manufacturing Practices (cGMP) regulations, among other matters." On this news, Atossa shares declined $0.3869 per share or nearly 5.6%, to close at $6.54 per share on February 25, 2013.
On October 4, 2013, after the market closed, the Company announced "a voluntary recall to remove the ForeCYTE Breast Health Test and the Mammary Aspiration Specimen Cytology Test (MASCT) device from the market" after receiving a warning letter from the U.S. Food and Drug Administration ("FDA"). On this news, Atossa shares declined $2.47 per share, or more than 46%, to close at $2.85 per share on October 7, 2013.
On February 14, 2014, the Court issued an Order appointing lead plaintiff and approving lead counsel. Lead Plaintiffs filed an amended complaint on April 15.
On October 6, 2014, the Court issued an Order granting Defendants' Motion to Dismiss. Plaintiffs were given leave to file an amended complaint. Plaintiffs did not file an amended complaint within the deadline. As such, the Court dismissed this case with prejudice on October 30. Plaintiffs filed a Notice appealing this Order to the United States Court of Appeals on November 3.
On September 11, 2017, the Court of Appeals issued a Mandate affirming in part, reversing in part, vacating in part, and remanding for further proceeding.