INVESTOR NOTICE: The Rosen Law Firm Announces Securities Fraud Class Action
Against Delcath Systems, Inc. - DCTH
NEW YORK -- May 20, 2013
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.
(Nasdaq: 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
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
Laurence M. Rosen, Esq.
Phil Kim, Esq.
The Rosen Law Firm P.A.
275 Madison Avenue 34^th Floor
New York, New York 10016
Tel: (212) 686-1060
Toll Free: 1-866-767-3653
Fax: (212) 202-3827
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