NEWS ALERT ! I found at FDA site that Delcath Systems, Inc. (DCTH) liver drag was approved by FDA, but management did not underline such great news= in order to depress share price /
Read below -and think how much (DCTH) shares relay worth visa-ave similar drag company which are trading over $32 dollars .
Percutaneous Hepatic Perfusion (PHP) vs. Cisplatin/Gemcitabine in Patients with Intrahepatic Cholangiocarcinoma - NCT03086993
In March 2017 we announced another SPA agreement with the FDA for the design of a new pivotal trial of Melphalan/HDS to treat patients with intrahepatic cholangiocarcinoma (ICC).
The pivotal trial is titled “A Randomized, Controlled Study to Compare the Efficacy, Safety and Pharmacokinetics of Melphalan/HDS Treatment Given Sequentially Following Cisplatin/Gemcitabine versus Cisplatin/Gemcitabine (Standard of Care) in Patients with Intrahepatic Cholangiocarcinoma .”
Under the SPA, the study will enroll approximately 295 ICC patients at approximately 40 clinical sites in the U.S. and Europe.
The primary endpoint is overall survival (OS) and secondary and exploratory endpoints include safety, progression-free survival (PFS), overall response rate (ORR) and quality-of-life measures. We expect to initiate the study in the Fall of 2017.
This pivotal study in ICC is designed to be cost effective and pursued in a financially prudent manner. Given the sequential nature of the trial design, our investment in this study will be modest in 2017 as the Melphalan/HDS segment of the study will not occur until late in the year.
The SPA agreement for this trial indicates that the pivotal trial design adequately addresses objectives that, if met, would support regulatory requirements for approval of Melphalan/HDS in ICC.
The mind is like a parachute it works best when it is open
