NEW YORK, May 18, 2013 /PRNewswire/ -- Faruqi & Faruqi, LLP, a leading national securities law firm, is investigating potential securities fraud at Delcath Systems, Inc. ("Delcath" or the "Company") (NASDAQ: DCTH).
The investigation focuses on whether the Company and its executives violated federal securities laws by failing to disclose that: (1) the Company's New Drug Application ("NDA") for Melblez Kit for the treatment of patients with unresectable ocular melanoma metastatic to the liver contained risks including fatal levels of toxicity associated with the drug's adverse reactions; and (2) the Company's manufacturing facilities were in violation of the United States' Current Good Manufacturing Practices ("cGMP").
On February 22, 2011, Delcath disclosed that it had received a "refusal to file" letter from the U.S. Food & Drug Administration ("FDA") requesting "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") to review Delcath's Melblez Kit. The briefing documents revealed that a staggering 7% of the 122 patients treated with the Melbaz 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 to not recommend approval of Delcath's Melblez Kit, noting that the benefits of treatment did not outweigh the risks. On this news, Delcath shares declined $0.3326 per share or nearly 42%, to close at $0.46 per share on May 3, 2013.
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If you invested in Delcath stock or options between April 21, 2010 and May 2, 2013 and would like to discuss your legal rights, visit www.faruqilaw.com/DCTH. You can also contact us by calling Richard Gonnello or Francis McConville toll free at 877-247-4292 or at 212-983-9330 or by sending an e-mail to firstname.lastname@example.org or email@example.com. Faruqi & Faruqi, LLP also encourages anyone with information regarding Delcath's conduct to contact the firm, including whistleblowers, former employees, shareholders and others.
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