b'appropriate dose for patients with late-stage PBC, thea generic version of a drug, and requires a manufac-form did not force providers to prescribe a higher thanturer to demonstrate that the proposed generic drug is recommended dose, and there were no allegations thatcomparable to the branded drug on which it is based in Intercept disseminated incorrect dosage instructions todosage form, strength, route of administration, quality, doctors. Nor were defendants statements about dosingperformance characteristics, and intended use, and that compliance misleading in light of 12 known instancesthe drug can be consistently produced.of misdosing, because the statements at issue madeIn September 2016 and October 2017, FDA conducted no concrete representations and were couched ininspections at Teligents manufacturing facility. Each in-general terms, such that they would not be misleadingspection resulted in a Form 483, which identified issues to a reasonable investor. with the companys quality control procedures, testing, The court independently dismissed the complaint forrecords maintenance, and the quality of the studies be-failure to plead facts raising a strong inference of scien- ing conducted at the facility. Throughout this time peri-ter. The court first held that the complaint contained nood, Teligent made statements describing its compliance allegations that the individual defendants engaged inand pipeline capabilities that it believed would result in unusual or substantial stock sales, and concluded thatsuccessful launches of the companys generic products. the motive cited in the complaintmaximizing profitIn press releases, conferences and calls with investors, for the companywas too generalized to supportthe CEO underscored the companys successful track an inference of scienter. The court also held that therecord with FDA and noted its expanded manufacturing complaint failed to allege particularized facts providingcapabilities, which would lead to increased revenue. a basis to infer that the individual defendants knew atThe company did not disclose its receipt of any Forms the time the pre-HCP Letter statements were made that483, and its CEO stated in May 2017 that Teligent had patients had been misdosed, or the scope, severity, ornot received any Form 483 in the last five years. During even existence of the SAEs at issue. The court furtheran investor call, Teligents CEO also referred to delays held that none of the statements after the individual de- caused by regulatory issues involving its suppliers, fendants knew of the SAEs were inconsistent with thebut did not disclose that Teligent was experiencing existence of such SAEs. The complaint also failed to ad- regulatory issues. In Teligents 2016 Form 10-K and equately plead the scienter of Intercept itself because2017 10-Qs, the company included risk disclosures that there were no allegations that any management-levelnoted the potential impact of non-compliance, but did employee of Intercept both knew of the SAEs andnot disclose the Forms 483. In November 2017, Teligent approved or were aware of the allegedly misleadingdisclosed disappointing earnings, attributing the neg-statements at issue. ative results primarily to pipeline delays and manufac-Following the motion to dismiss opinion, plaintiffsturing challenges. The next day, the companys stock moved for reconsideration and for leave to file a seconddropped 44%.amended complaint, which the court denied. Plaintiffs have appealed the courts decision to the Second Circuit. Plaintiffs appeal is pending, and is expected to be fully briefed by March 13, 2021. Likewise, the court concluded that Oklahoma Police Pension Fund andstatements in press releases and Retirement System v Teligent Inc.,conference calls reflecting that the Case No. 19-cv-3354 (VM), 2020company was committed to upholding WL 3268531 (S.D.N.Y. June 17, 2020) [its] responsibilities with respect to the Undisclosed Regulatory Issues FDA to ensure the timely processing of [its] Teligent Inc. (Teligent) is a pharmaceutical companyapplications and that the business was that manufactures topical ointments and lotion drug products. In April 2014, Teligents CEO announced[b]uilt on a solid product development plans to accelerate the companys shift in focus fromplatform, excellent regulatory capabilities contract services to developing its own generic prod-ucts through research and development. One of theand timely and effective product launch goals set by Teligents CEO at this time was to file atconstituted non-actionable puffery and least ten Abbreviated New Drug Applications (ANDA) for generic topical pharmaceutical products. An ANDAwere protected by the PSLRAs safe harbor.is an application which seeks FDA approval to market 32'