b'Plaintiffs appealed, and the First Circuit affirmed. Asclaims, and there was no common scheme tying to-to plaintiffs 1933 Act claims, the court rejected thegether pre- and post-IPO statements and/or omissions, argument that ReWalks disclosures in the registrationin a manner that could support standing as to the statement were misleading for failing to reveal thatpost-IPO statements. The court, however, disagreed the FDA specifically determinedthat the . deviceswith the district courts conclusion that it lacked juris-failure to prevent a fall would be reasonably likely todiction to entertain plaintiffs motion to amend to add cause serious injury or death. The First Circuit em- another investor as lead plaintiff for the 1934 Act claims, phasized that the registration statement expresslyconcluding that, contrary to the district courts holding, highlighted the risk of serious injury and death in theplaintiffs lack of standing did not prevent the court from event of a malfunction, and observed that, contrary toresolving the motion to amend. The court nonetheless plaintiffs characterizations, FDA did not determine thataffirmed denial of the motion to amend, on the basis the device was reasonably likely to result in seriousthat the proposed amended complaint did not ade-injury or death. Instead, FDA stated only that, based onquately plead scienter. In particular, the court held that the limited information it had available on the rate andthe proposed amended complaint (1) failed to allege nature of falls stemming from use of the device, a train- any statements with respect to ReWalks FDA proceed-ing program may help mitigate potential risks. In short,ings that ReWalk knew or should have known were because the registration statement disclosed both (1)incorrect or inconsistent with prior disclosures, (2) did that FDA sought assurance of the devices safetynot contain any allegations that defendants saw FDAs and (2) the primary safety issue associated with thewarning letter as directing ReWalk to take actions that device, the representations at issue in the registrationit did not intend to take, and (3) included no allegations statement were not misleading. The court also rejectedcasting ReWalks statements in a suspicious light. The plaintiffs reliance on statements highlighting compel- First Circuit affirmed the district courts denial of the mo-ling clinical data and asserting that the device was ation to amend and dismissal of the amended complaint.breakthrough product, which the court concluded were non-actionable vague statements of optimism, or puffery. Finally, the court rejected plaintiffs 1933Angelos v. Tokai Pharmaceuticals, Inc., Act claims based on affirmative disclosure obligationset al., Case No. 17-cv-11365 (MLW), 2020 under Items 105 and 303 of Regulation S-K, holding thatWL 5995598 (D. Mass. Oct. 9, 2020)the registration statement adequately disclosed theTrial Enrollment and Discontinuationrisks at issue.With respect to the 1934 Act claims, the First Circuit firstTokai Pharmaceuticals, Inc. (Tokai) was a pharmaceu-agreed with the district courts conclusion that plaintifftical company developing an experimental prostate lacked standing to pursue such claims. In particular,cancer treatment drug called galeterone, its sole devel-plaintiff had purchased his shares in September 2014,opment focus since 2008 and its only drug candidate. well before the representations at issue in the 1934 ActGaleterone was specifically intended to treat meta-static castration-resistant prostate cancer (CRPC). In September 2014, Tokai completed an IPO. At the time of the IPO, galeterone was in the midst of a Phase 2 In particular, the court held that thetrial and in its registration statement for the IPO, Tokai proposed amended complaint (1) faileddisclosed that pre-clinical study data and a retro-spective subset analysis of Phase 2 data supported a to allege any statements with respect tobelief that galeterone may be effective in a particular ReWalks FDA proceedings that ReWalksubset of CRPC patientsthose exhibiting truncated androgen receptors as having C-terminal loss (the AR-knew or should have known were incorrectV7+ patients). The registration statement announced or inconsistent with prior disclosures,Tokais intent to pursue a Phase 3 trial studying ga-leterones effectiveness in AR-V7+ patients, with the (2) did not contain any allegations thatend goal of obtaining FDA approval to market the drug defendants saw FDAs warning letter asto such patients. Tokai, however, had not conducted a Phase 2 trial specifically aimed at testing galeterones directing ReWalk to take actions that iteffectiveness in AR-V7+ patients, and instead relied did not intend to take, and (3) included noon a retrospective analysis of its more general Phase 2 data to support its belief that galeterone would be allegations casting ReWalks statementseffective. In June 2015, Tokai commenced a Phase 3 in a suspicious light. trial for galeterone and, over the ensuing year, made several public statements about the trial, including that 14'