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December 5, 2012
18:02 EDTDCTHDelcath Systems announces modification of NDA for liver treatment
Delcath Systems announced that after recent discussions with the FDA, management has elected to modify the label indication it is seeking in its New Drug Application for its proprietary chemosaturation system with melphalan hydrochloride for injection. Although the company's Phase 3 trial demonstrated a very positive signal in patients with liver dominant cutaneous melanoma, based upon a recommendation from the FDA, Delcath has decided to focus the company's NDA indication on the treatment of patients with unresectable metastatic ocular melanoma in the liver. The company believes that its data in ocular melanoma metastases in the liver, coupled with the large unmet need for treatments for this disease, presents the most compelling case for the company's NDA.
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April 9, 2014
12:00 EDTDCTHDelcath Systems falls 21.8%
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10:00 EDTDCTHDelcath Systems falls 20.7%
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09:00 EDTDCTHDelcath Systems falls 16.4%
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