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Delcath Systems Provides Update on Corporate Developments
Date:3/12/2010

schedule to obtain CE Mark in Europe.  We recently confirmed that the Delcath PHP System will be treated as a Class III device in Europe, requiring additional validation testing and documentation. We anticipate filing for this approval by the end of the year, or approximately six months later than originally envisioned.  Once complete, these data will also be used to complete the CMC module of our rolling NDA submission in the U.S.  All other approval timelines are expected to remain on track," said Mr. Hobbs.

"We continue to actively negotiate strategic partnership transactions similar in structure to the agreement recently reached with Chi-Fu Trading Co. for the Taiwan market.  Our goal is to execute additional partnerships that will serve both strategic and financial needs. These partnerships will provide distribution and expanded clinical indications in key Asian markets as well as strengthen our capital position. Given that the timing of such agreements is unpredictable, we will continue to review other financing options to assure that the company maintains flexibility and is adequately capitalized to execute on the opportunities ahead of us as we move toward commercialization," concluded Mr. Hobbs.

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Related medicine technology :

1. Delcath Expands Phase III Trial for Metastatic Melanoma to Include University of Maryland Medical Center
2. Delcath Updates Phase III Patient Enrollment as Pivotal Trial Accelerates, Durable Tumor Responses In Phase II Study Also Cited
3. Delcath Expands Phase III Trial for Metastatic Melanoma to Include St. Lukes Cancer Center
4. Delcath Adds Dr. Pamela R. Contag to Its Board of Directors
5. Delcath Continues Expansion of Clinical Trial Centers Offering PHP(TM)
6. Enrollment in Delcaths Pivotal Phase III Metastatic Melanoma Clinical Trial Achieves Seventy-Five Percent Accrual
7. Data Safety Monitoring Board Unanimously Recommends Continuation of Delcaths Phase III Clinical Trial
8. Delcath Systems, Inc. Appoints Dr. Krishna Kandarpa its Executive Vice President R&D and Chief Medical Officer
9. Delcath Systems, Inc. Completes Phase III Study Enrollment
10. Delcath Systems Begins Data Analysis of Phase III Trial
11. Delcath Systems, Inc. to Present at the 12th Annual Needham Growth Stock Conference
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