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Re: Turntheship post# 33833

Monday, 02/19/2018 3:04:43 PM

Monday, February 19, 2018 3:04:43 PM

Post# of 50157
The gold standard? BWAHAHA. Gold standard if you want to hear about DCTH going to $370 (in Fantasyland). Sam, and sidekick Turntheship, like to jump through wormholes to provide approval dates well into the next century.

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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