Document Request in Connection With Pending Case in the Southern District of New York: In re HeartWare International, Inc. Securities Litigation, No. 1:16-cv-00520-RA (S.D.N.Y.)
Please provide all Documents and Communications from January 1, 2014 to October 24, 2017 concerning:
(1) The HeartWare MVAD System for the Treatment of Advance Heart Failure (“MVAD”), HeartWare International, Inc.’s heart pump, including but not limited to all Documents and Communications related to MVAD’s safety, including any analyses, audits, conclusions, and determinations; and any Communications with HeartWare, Chiltern International, Ltd., the U.S. Food and Drug Administration, or any study investigators concerning MVAD;
(2) MVAD’s Multi Center, Prospective, Non-Randomized Single-Arm Trial Evaluating the Clinical Safety and Performance of the HeartWare MVAD System for the Treatment of Advance Heart Failure (MVAdvantage) (ClinicalTrials.gov identifier: NCT01831544) (the “CE Mark Trial”), including but not limited to clinical trial protocols; data analysis plans; and Communications with HeartWare, Chiltern International, Ltd., the U.S. Food and Drug Administration, or any study investigators, including Communications concerning any delay, pause, postponement, or cancellation of enrollment, implantation, or data analysis in the CE Mark Trial; and
(3) Adverse events during the CE Mark Trial and the causes thereof, including pump thrombosis.
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Datum25. Juli 2018
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28. August 2018
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