b'the company currently complied in all respects. Thein June 2014; classified the device as a Class II court then turned to the statements by an Ocular officermedical device, which requires special controls; and, during the May 2017 earnings call that the companysbecause of concerns that a malfunction could result manufacturing process was fully developed, and heldin serious injury or death, ordered the company to that plaintiffs failed to adequately plead scienter withconduct a post-market surveillance study to examine respect to these statements as well. In particular, thesethe products risks, as required by Section 522 of the statements were accompanied by various other disclo- Food, Drug, and Cosmetic Act (FDCA). In advance sures about the May 2017 Form 483, which expresslyof its September 2014 IPO, ReWalk filed a registration highlighted the need to address and resolve issuesstatement with the SEC, which disclosed that FDA had raised by FDA. This disclosure, according to the court,ordered the post-market surveillance study, but did not rendered pellucid that FDA considered Oculars man- explicitly reveal that FDA ordered the study because of ufacturing processes deficient, and in turn undercut anythe reasonably likelihood that device malfunction may inference that the statements were made to intentional- result in spinal cord, brain, and skeletal injuries, or even ly or recklessly mislead investors. death. Two weeks after the IPO, FDA informed ReWalk that its proposed post-market surveillance study plan was deficient, and gave ReWalk 30 days to respond The court separately reasoned that evenwith a revised study plan. ReWalk failed to respond within the allotted timeframe, and then submitted a if an inference of scienter could be drawnresponse that FDA found deficient. Several additional from the complaints allegations, the moretimes thereafter, ReWalk repeatedly missed its FDAresponse deadlines, and then submitted another defi-reasonable inference was that defendantscient response.were expressing an intent to comply withBy September 2015, ReWalk still had not submitted a cGMP in its Forms 10-K, not claiming that therevised study plan. That month, FDA issued a warning letter explaining that by not beginning its surveillance company currently complied in all respects. study within 15 months after issuance of the Section 522 order as required under the FDCA, ReWalk had committed a prohibited act under the FDCA, and the Wang Yan v. ReWalk Robotics Ltd., et al.,device was currently misbranded. In the meantime, Case No. 19-1614, 973 F.3d 22 (1st Cir. 2020)from February 2015 to February 2016, ReWalk had held a series of earnings calls, during which the company Post-Marketing Study and FDA Warning did not disclose this correspondence with FDA or FDAs ReWalk Robotics, Ltd. (ReWalk), formerly known asdissatisfaction with the surveillance plan. At the end of Argo Medical Technologies, Inc., which is incorporatedMarch 2016, FDA notified ReWalk that it could continue in Israel and headquartered in Massachusetts, is a med- to market the device, provided that a post-market sur-ical technology company that develops exoskeletonsveillance study began by June 2016. FDA subsequentlydevices which help patients suffering from spinalapproved ReWalks proposed protocol for the study in injuries. ReWalk sells two products: ReWalk Personal,May 2016. ReWalk did not timely file required monthly designed for personal use, and ReWalk Rehabilitation,reports for the surveillance study in June or July 2016. designed for clinical rehabilitation centers. ReWalkBy June 2017, ReWalk had not recruited the required submitted the ReWalk Personal Device (the device)number of subjects for the study, and FDAs post market to FDA in 2014 for approval. FDA granted approvalsurveillance studies webpage listed the status of the study as progress inadequate.11'