INVESTOR NOTICE: The Rosen Law Firm Announces Securities Fraud Class Action Against Delcath Systems,
INVESTOR NOTICE: The Rosen Law Firm Announces Securities Fraud Class Action Against Delcath Systems, Inc. - DCTH
NEW YORK--(BUSINESS WIRE)-- The Rosen Law Firm today announced that a class action lawsuit has been filed on behalf of investors who purchased the securities of Delcath Systems, Inc. (NAS: DCTH) during the period from April 21, 2010 through May 2, 2013, seeking to recover damages for violations of the federal securities laws.
To join the Delcath class action, visit the firm's website at http://rosenlegal.com, or call Phillip Kim, Esq. toll-free, at 866-767-3653; you may also email firstname.lastname@example.org for information on the class action.
NO CLASS HAS YET BEEN CERTIFIED IN THE ABOVE ACTION. UNTIL A CLASS IS CERTIFIED, YOU ARE NOT REPRESENTED BY COUNSEL UNLESS YOU RETAIN ONE. YOU MAY CHOOSE TO DO NOTHING AT THIS POINT AND REMAIN AN ABSENT CLASS MEMBER.
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 the Company's business, operations, and prospects. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (1) the Company's New Drug Application ("NDA") for Melblez Kit (Melblez (melphalan) for Injection for use with the Delcath Hepatic Delivery System), for the treatment of patients with unresectable ocular melanoma metastatic to the liver contained risks including substantial and severe toxicity and deaths associated with the drug's adverse reactions; and (2) the Company's manufacturing facilities were in violation of Current Good Manufacturing Practices ("cGMP").
On February 22, 2011, the Company disclosed that it had received a "refusal to file" letter from the U.S. Food & Drug Administration ("FDA") for its NDA for its proprietary chemosaturation system. The letter "requested information involving manufacturing plant inspection timing, product and sterilization validations and additional safety information [...] as well as additional statistical analysis clarification." On this news, Delcath shares plummeted $4.29 or 38%, to close at $7.01 per share.
On April 30, 2013, the FDA published briefing documents ahead of a May 2, 2013 meeting by the Oncologic Drugs Advisory Committee ("ODAC"). The briefing documents concluded, among other things, that "substantial evidence of effectiveness in adequate and well controlled clinical trials utilizing the proposed drug-device combination product and a favorable benefit risk profile is required for approval." Moreover, the briefing documents revealed that a staggering 7% of the 122 patients treated with the Melblez kit died as a result of the treatment. On this news, Delcath shares declined $0.558 per share or over 40%, to close at $0.832 per share on April 30, 2013.
On May 2, 2013, the Company announced that the ODAC voted 16 to 0 that benefits of treatment with Delcath's Melblez Kit do not outweigh the risks associated with the procedure. On this news, Delcath shares declined $0.3326 per share or nearly 42%, to close at $0.46 per share on May 3, 2013.
If you wish to serve as lead plaintiff, you must move the Court no later than July 8, 2013. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation. If you wish to join the litigation, or to discuss your rights or interests regarding this class action, please contact Phillip Kim, Esq. of The Rosen Law Firm, toll-free, at 866-767-3653, or via e-mail at email@example.com. You may also visit the firm's website at http://rosenlegal.com.
The Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation.
Laurence M. Rosen, Esq.
Phil Kim, Esq.
The Rosen Law Firm P.A.
275 Madison Avenue 34th Floor
New York, New York 10016
Tel: (212) 686-1060
Toll Free: 1-866-767-3653
Fax: (212) 202-3827
KEYWORDS: United States North America New York
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