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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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September 17, 2014
13:05 EDTDCTHLinkedto says $3 per share bid for Delcath Systems dropped
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September 15, 2014
10:33 EDTDCTHLinkedto says two public companies interested in Delcath Systems
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07:06 EDTDCTHDelcath Systems appoints Dr. Jennifer Simpson as Interim-CEO
Delcath Systems announced the reorganization of the company's leadership as Dr. Jennifer Simpson has been appointed interim president and interim CEO. Dr. Simpson has served as interim co-president and interim Co-CEO of Delcath since September 2013. Dr. Graham Miao, who has served as interim co-president, interim Co-CEO and CFO will be leaving the company at the end of September to pursue other opportunities. Barbra Keck, currently vice president, Controller & Principal Accounting Officer will assume the responsibilities of Principal Financial Officer. In addition, Dr. Roger G. Stoll, who has been a member of the Delcath board since 2008, has been appointed to the newly created position of Executive Chairman. He succeeds Gabriel Leung, who is stepping down from his position as chairman. Leung will remain on the Board, but his schedule demands inhibited his ability to continue as chairman.
September 9, 2014
12:52 EDTDCTHLinkedto raises unsolicited bid for Delcath Systems to $3.00 per share
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September 8, 2014
09:44 EDTDCTHLinkedto raises unsolicited bid for Delcath Systems to $2.90 per share
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September 5, 2014
10:14 EDTDCTHLinkedto seeks talks on $2.85 per share unsolicited bid for Delcath Systems
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