b'there was allegedly no agreement between FDA andfraudulent intent, but observed that in circumstances Acer that the Ong Trial Data would be sufficient.in which a companys survival depends on additional Defendants moved to dismiss, and the district courtfundraising, officers and senior executives may have granted the motion in part and denied it in part. Thean incentive to bet the farm in a reckless gamble be-court first held that plaintiff sufficiently alleged thatcause the alternative is certain failure. Combined with statements in Acers offering materials for its two publicplaintiffs other factual allegations, the court held that offerings reflecting that FDA had agreed that furtherplaintiff adequately alleged scienter.trials were not needed before Acer filed an NDA wereDefendants answered plaintiffs complaint in August false or misleading. The court rejected defendants2020, and the case is now in discovery. Summary judg-ment motions are due by October 1, 2021.The court found it significant that the 2017In re Mylan N.V. Securities Litigation, Case statement was unqualified in reflectingNo. 16-cv-7926 (JPO), 2020 WL 1673811 (S.D.N.Y. Apr. 6, 2019) that FDA agreed that additional clinicalMedicaid Misclassification and development is not needed, whereasAntitrust Violationsthe 2018 statement was hedged by theMylan N.V. (Mylan) is a pharmaceutical developer, phrase likely. The court concluded thatmanufacturer and distributor. Mylans products in-clude the EpiPen Auto-Injector (EpiPen) and various defendants decision to alter the wordinggeneric drugs such as doxycycline hyclate delayed of their public statements suggests that therelease (Doxy DR). In October 2016, Mylan entered into a $465 million settlement with the Department of first statement was inaccurate. Justice (DOJ) concerning allegations that the com-pany misclassified the EpiPen as a generic drug under the Medicaid Drug Rebate Program (MDRP). Until this settlement announcement, Mylan and its execu-arguments that the statements merely conveyed FDAstives allegedly did not disclose the misclassification, its agreement that Acer could submit its NDA for approval,impact on Mylans reported revenues, or the risk that and not that FDA had necessarily agreed to approveMylan would be required to pay regulatory penalties the NDA without further testing. The court concludedas a result of the misclassification. Mylan also allegedly that although Acers statements were ambiguous onengaged in multiple antitrust violations, including entry this question, that ambiguity should be construed in fa- into numerous anticompetitive pay for delay, exclusive vor of plaintiff at the pleadings stage, without prejudicedealing, market allocation, and price fixing agreements to revisiting the conclusion at a later stage. The courtwith its competitors and customers with regard to the granted defendants motion to dismiss with respect toEpiPen and various generic drugs. In December 2016, the other statements at issue in the complaint, whichattorneys general from 20 states filed a civil lawsuit reflected that FDA had provided Acer with guidanceconcerning alleged antitrust violations by Mylan.for presenting its clinical data. As to these statements,Mylan investors filed a putative class action complaint the court held that the complaint failed to allege factsagainst Mylan and its officers, alleging violations of suggesting that FDA had not, in fact, provided Acer withSections 10(b) and 20(a), and Rule 10b-5 of the 1934 such guidance.Act, and Section 1 of the Israeli Securities Law, alleg-The court also held that plaintiff adequately pleaded ing that the defendants made misleading statements scienter with respect to the allegedly misleading concerning (1) Mylans historical income and the drivers statements. The court found it significant that the 2017underlying Mylans income, and (2) the competitiveness statement was unqualified in reflecting that FDA agreedof the generic drug market, which plaintiffs alleged that additional clinical development is not needed,were misleading by virtue of Mylans failure to disclose whereas the 2018 statement was hedged by theits own anticompetitive conduct and potential risk of phrase likely. The court concluded that defendantsregulatory action. Defendants moved to dismiss, which decision to alter the wording of their public statementsthe court granted in part. Plaintiffs subsequently filed a suggests that the first statement was inaccurate. Thesecond amended complaint, which included allegations court also rejected Defendants argument that thebased on a confidential witnesss accounts, as well as absence of stock sales by Acers insiders was inconsis- allegations concerning Mylans misclassification of the tent with an intent to defraud. The Court acknowledgedEpiPen; the sale of the EpiPen on a rebate to third-party that the absence of such sales can signal a lack ofpayors on the condition that they refuse to reimburse a 27'