PR Newswire
BENSALEM, Pa., Nov. 19, 2020 /PRNewswire/ — Law Offices of Howard G. Smith 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”).
Investors suffering losses on their Neovasc investments are encouraged to contact the Law Offices of Howard G. Smith to discuss their legal rights in this class action at 888-638-4847 or by email to [email protected].
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.
If you purchased or otherwise acquired Neovasc securities during the Class Period, you may move the Court no later than January 5, 2021to ask the Court to appoint you as lead plaintiff if you meet certain legal requirements. To be a member of the class action you need not take any action at this time; you may retain counsel of your choice or take no action and remain an absent member of the class action. If you wish to learn more about this class action, or if you have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Howard G. Smith, Esquire, of Law Offices of Howard G. Smith, 3070 Bristol Pike, Suite 112, Bensalem, Pennsylvania 19020, by telephone at (215) 638-4847, toll-free at (888) 638-4847, or by email to [email protected], or visit our website at www.howardsmithlaw.com.
This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.
Contacts
Law Offices of Howard G. Smith
Howard G. Smith, Esquire
215-638-4847
888-638-4847
[email protected]
www.howardsmithlaw.com
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SOURCE Law Offices of Howard G. Smith
