Plaintiffs allege that the pharmaceutical company Sanofi, along with its predecessor and three company executives, made materially

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Plaintiffs allege that the pharmaceutical company Sanofi, along with its predecessor and three company executives, made materially false or misleading statements regarding its breakthrough drug, Lemtrada, designed to treat multiple sclerosis (MS). In part because of Lemtrada's unique treatment design, Genzyme used a single-blind study in its early clinical trials. In a single-blind study, either the researcher or the patient does not know which drug was administered. The FDA prefers doubleblind studies, and repeatedly told Defendant the lack of double-blind studies was troubling, but the FDA continued to provide the company encouragement. Plaintiffs allege that while Lemtrada was undergoing Phase III clinical trials prior to FDA approval, Sanofi misled investors by failing to disclose that the FDA had repeatedly expressed concern with Sanofi's use of single-blind studies and had encouraged Sanofi to use double-blind studies in its clinical trials. Plaintiffs allege that these omissions misled investors and artificially inflated the value of Plaintiffs' contingent value rights (CVRs), specialized financial instruments whose value is tied to the achievement of certain "milestones." While defendants remained optimistic, the FDA did not approve the drug before the milestone was met, causing the value of the stock to fall. Plaintiffs' filed their action alleging violations of Sections 10(b), 18, and 20(a) of the Securities Exchange Act of 1934, 15 U.S.C. Section 78a et seq., and Sections 11 and 12 of the Securities Act of 1933, 15 U.S.C. Sections 77a et seq. Defendants filed a motion to dismiss, which the trial court granted, finding that the defendants had made no false or misleading statements but had merely expressed their optimistic beliefs as to how the FDA would act in the future. How do you believe the appellate court ruled in the case? Why? [Gen. Partner Glenn TONGUE, Deerhaven Capital Management, et al v. Sanofi Pharmaceuticals, Inc., Consolidated, et.al, caselaw.findlaw.com/Us-2dcircuit/ 1727858 (2016).]

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Dynamic Business Law The Essentials

ISBN: 978-1259917103

4th edition

Authors: Nancy Kubasek, Neil Browne, Daniel Herron

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