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Monday, February 19, 2018 3:04:43 PM
Turntheship, perhaps you could post a bit about how the FDA relaxed the protocol regime for Phase 3:
Delcath Announces Special Protocol Agreement Modification With FDA
NEW YORK, Jan. 10, 2018 (GLOBE NEWSWIRE) -- Delcath Systems, Inc.
(OTCQB:DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, announces that it has concluded a modification agreement with the U.S. Food and Drug Administration (FDA) for its Phase 3 clinical trial of Melphalan Hydrochloride for Injection for use with the Delcath Hepatic Delivery System (Melphalan/HDS) to treat patients with hepatic dominant ocular melanoma (The FOCUS Trial). The modification agreement revises the FOCUS trial’s eligibility criteria to permit a greater extent of extra-hepatic disease by removing the size restriction, number and location of extra-hepatic lesions, in conjunction with a treatment plan for the extra-hepatic metastases.
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