b'the court held that plaintiffs allegation that Alnylam mispresented patisirans safety was refuted by FDAs own review, which concluded that patisiran was safe. Fourth, the court held that statements concerning FDAs potential approval of patisiran were forward-looking and protected by the PSLRAs safe harbor, as they were accompanied by disclosures identifying patisirans potential risks and expressly stated that FDA approval was not guaranteed. Independently, the court also held that plaintiffs had not pled facts sufficient to raise a strong inference of scienter, because the complaint failed to plead defendants knowledge of the falsity of their cardiomyopathy-related statements and because stock sales cited by plaintiffs were not sufficiently large or unusual to suggest scienter.On June 1, 2020, plaintiffs filed a motion for leave to file a second amended complaint. Defendants have opposed this motion, and briefing was complete as of September 2020. The court has not yet ruled on plain-tiffs motion. On this point, the court rejected the sufficiency of plaintiffs allegations that the Phase 3 trial did not address cardiomyopathy, and noted that, to the contrary, the study contained a number of measures intended to address cardiac functions, refuting the inference plaintiffs asked the court to draw.'