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Delcath Systems Receives Refusal to File Letter From FDA

Tue, 02/22/2011 - 1:34am
Bio-Medicine.Org

NEW YORK, Feb. 22, 2011 /PRNewswire/ -- Delcath Systems, Inc. (Nasdaq: DCTH) announced today that the Company has received a "refusal to file" letter from the U.S. Food & Drug Administration (FDA) for the New Drug Application (NDA) for its proprietary chemosaturation system used in the treatment of patients with metastatic melanoma in the liver through the percutaneous intra-arterial administration of melphalan hydrochloride.  Delcath expects to submit a formal meeting request to the FDA this week and intends to meet with the FDA at the earliest opportunity to discuss the issues raised and to confirm our understanding of the remedies required for the filing to be accepted.  Based on management's current understanding of the information in the FDA's letter, the Company intends to resubmit the NDA by September 30, 2011.  

In accordance with application regulations, the FDA has the ability to formally file or refuse to file an application within 60 days of the completion of the submission, which occurred on December 22, 2010.  Neither the acceptance nor non-acceptance of the NDA filing is a determination of the approvability of the chemosaturation system.

"The FDA's letter requested information involving manufacturing plant inspection timing, product and sterilization validations and additional safety information that we already planned on filing with our 120 day safety update in April, as well as additional statistical analysis clarification," said Eamonn P. Hobbs, CEO & President of Delcath Systems. "We believe that we will be able to provide the requested information in an updated application and we expect to resubmit the NDA by the end of the third quarter of this year.  In the meantime, the CE Mark Technical File review process for marketing approval of the Hepatic ChemoSAT™ Delivery System continues on schedule.  Our expec

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