LOS ANGELES– The Law Offices of Frank R. Cruz reminds investors of the upcoming January 5, 2021 deadline to file a lead plaintiff motion in the class action filed on behalf of investors who purchased Neovasc Inc. (“Neovasc” or the “Company”) (NASDAQ: NVCN) securities between November 1, 2019 and October 27, 2020, inclusive (the “Class Period”).
In December 2018, the Company filed a Q-Sub submission to the U.S. Food and Drug Administration (“FDA”) that contained safety and efficacy results from Neovasc’s clinical studies, as well as supporting data from peer-reviewed journals.
On February 20, 2019, Neovasc announced that, despite “Breakthrough Device Designation,” the FDA review team recommended that the Company collect further pre-market blinded data prior to submitting a Pre-Market Approval (“PMA”) application.
On November 1, 2019, the Company announced that it would submit a PMA application for the Reducer without gathering further evidence, against the FDA’s recommendation. Neovasc claimed that “the clinical evidence already available will be sufficient to not further delay the availability of this Breakthrough medical device for the treatment of U.S. patients.”
On October 28, 2020, before the market opened, the Company announced that an FDA advisory panel voted overwhelmingly against the safety and effectiveness of the Reducer. The panel noted concerns with the Company’s clinical data, including “that the lack of blinding assessment made the primary endpoint difficult to interpret.” As a result, the panel reached a consensus “that additional premarket randomized clinical data was necessary.”
On this news, the Company’s share price fell $0.77, or 42%, to close at $1.06 per share on October 28, 2020, on unusually heavy trading volume.
The complaint filed alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, Defendants failed to disclose to investors: (1) that the results of COSIRA, Neovasc’s clinical study for the Reducer, contained imbalances in missing information present in the control group versus the treatment group, including significant missing information for secondary endpoints but none for the primary endpoint; (2) that the imbalance in missing information indicated that control subjects were aware of their treatment assignment (not blinded) and less inclined to participate in additional data collection; (3) that blinding is critical when studying a placebo-responsive condition such as angina; (4) that the lack of blinding assessment made the primary endpoint difficult to interpret; (5) that, as a result of the foregoing, the FDA was reasonably likely to require additional premarket clinical data; (6) that, as a result, the Company’s PMA for Reducer was unlikely to be approved without additional clinical data; and (7) that, as a result of the foregoing, Defendants’ positive statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis.
