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NEW YORK, Feb. 8, 2023 /PRNewswire/ —
WHY: Rosen Law Firm, a global investor rights law firm, continues its investigation of potential securities claims on behalf of shareholders of Surmodics Inc. (NASDAQ: SRDX) resulting from allegations that Surmodics may have issued materially misleading business information to the investing public.
SO WHAT: If you purchased Surmodics securities you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arrangement. The Rosen Law Firm is preparing a class action seeking recovery of investor losses.
WHAT TO DO NEXT: To join the prospective class action, go to https://rosenlegal.com/submit-form/?case_id=11326 or call Phillip Kim, Esq. toll-free at 866-767-3653 or email pkim@rosenlegal.com or cases@rosenlegal.com for information on the class action.
WHAT IS THIS ABOUT: On January 19, 2023, Surmodics, Inc. announced it had received a letter from the U.S. Food and Drug Administration related to its premarket approval (PMA) application for the SurVeilTM drug-coated balloon (DCB). In the letter, the FDA indicated that the application is not currently approvable, while providing specific guidance as to a path forward. The letter stated that certain information within two general categories—biocompatibility and labeling—must be added by an amendment to the company’s PMA application to place it in approvable form. Although the information identified by the Agency to put the PMA application in approvable form would require additional testing and analysis, the letter did not question the human clinical data submitted nor request any further human clinical data. Surmodic stated, “We are evaluating the issues raised in the FDA’s letter and plan to meet with Agency representatives regarding its contents. Based on our discussion with the Agency, our team and external advisors will determine the appropriate path forward. Concurrently, we will be evaluating options to reduce our use of cash given this development.”
On this news, Surmodic’s price fell $10.57, or 28.31%, to close at $26.77 on January 19, 2023.
WHY ROSEN LAW:
Follow us for updates on LinkedIn: https://www.linkedin.com/company/the-rosen-law-firm, on Twitter: https://twitter.com/rosen_firm or on Facebook: https://www.facebook.com/rosenlawfirm/.
Attorney Advertising. Prior results do not guarantee a similar outcome.
Contact Information:
Laurence Rosen, Esq.
Phillip Kim, Esq.
The Rosen Law Firm, P.A.
275 Madison Avenue, 40th Floor
New York, NY 10016
Tel: (212) 686-1060
Toll Free: (866) 767-3653
Fax: (212) 202-3827
lrosen@rosenlegal.com
pkim@rosenlegal.com
cases@rosenlegal.com
www.rosenlegal.com
SOURCE Rosen Law Firm, P.A.
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