According to the Complaint, Defendants made false and/or misleading statements and/or failed to disclose that: (i) the Company concealed the true nature of the LUNAR study results—that the overwhelmingly positive way that the Company described them was only a half-truth at best given that the study failed to evaluate the efficacy of the drug against a population of patients that had been receiving standard of care treatment; (ii) as a result, the Company’s business prospects, effectiveness of its products, and ultimately the likelihood of FDA approval were materially misleading during the Class Period; (iii) the foregoing, once revealed, was reasonably likely to have a material negative impact on the Company’s financial condition; and (iv) as a result, the Company’s public statements were materially false and misleading at all relevant times.