The Complaint alleges that, throughout the Class Period, Defendants made materially false and misleading statements regarding the Company's business, operations, and compliance policies. Specifically, the Complaint alleges Defendants made false and/or misleading statements and/or failed to disclose that: (i) the teplizumab BLA was deficient in its submitted form and would require additional data to secure FDA approval; (ii) accordingly, the teplizumab BLA lacked the evidentiary support the Company had led investors to believe it possessed; (iii) the Company had thus overstated the teplizumab BLA's approval prospects and hence the commercialization timeline for teplizumab; and (iv) as a result, the Company's public statements were materially false and misleading at all relevant times.