XML 37 R16.htm IDEA: XBRL DOCUMENT v2.4.0.6
Subsequent Events
9 Months Ended
Sep. 30, 2012
Subsequent Events [Abstract]  
Subsequent Events
Note 11:                      Subsequent Events

During the fourth quarter through November 6, 2012, the Company sold approximately 1.7 million shares of our common stock under the Sales Agreement through an "at the market" equity offering program for net proceeds of approximately $3.0 million. The net proceeds will be used for general corporate purposes, including, but not limited to, commercialization of our products, obtaining regulatory approvals, funding of our clinical trials, capital expenditures and working capital. As of November 6, 2012, the Company has approximately $21.5 million remaining under the program.
 
 On October 15, 2012, Delcath announced that the U.S. Food and Drug Administration (FDA) has accepted the Company's New Drug Application (NDA) for its proprietary chemosaturation system with melphalan hydrochloride for injection.  The FDA has designated the NDA for standard review. 

On November 1, 2012, Delcath announced that the U.S. Food and Drug Administration 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) of its proprietary chemosaturation system with melphalan hydrochloride for injection. 
 
The Company completed an evaluation of the impact of any subsequent events through the date financial statements were issued and determined there were no other subsequent events requiring disclosure in or adjustment to these financial statements.