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DCTH > SEC Filings for DCTH > Form 8-K on 1-Nov-2012All Recent SEC Filings

Show all filings for DELCATH SYSTEMS INC

Form 8-K for DELCATH SYSTEMS INC


1-Nov-2012

Other Events, Financial Statements and Exhibits


Item 8.01. Other Events.

On November 1, 2012, Delcath Systems, Inc. (the "Company") issued a press release announcing that the U.S. Food and Drug Administration (the "FDA") assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 15, 2013, for substantive review of the Company's New Drug Application ("NDA") for its proprietary chemosaturation system with melphalan hydrochloride for injection. The FDA accepted the Company's NDA submission for filing on October 14, 2012, and designated the NDA for standard review.

A copy of the press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference.




Item 9.01. Financial Statements and Exhibits.

The following exhibits are filed herewith:

(d) Exhibits.

Exhibit
No. Description

99.1 Press Release of Delcath Systems, Inc., dated November 1, 2012


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