The Complaint alleges that, throughout the Class Period, Defendants made materially false and misleading statements regarding the Company’s business, operations, and prospects. Specifically, the Complaint alleges Defendants made false and/or misleading statements and/or failed to disclose that: (i) Fennec had not successfully remediated, and overstated its efforts to remediate, issues with the manufacturing facility of its drug product manufacturer for PEDMARK; (ii) as a result, the FDA was unlikely to approve the Resubmitted Pedmark NDA; (iii) accordingly, the regulatory and commercial prospects of the Resubmitted Pedmark NDA were overstated; and (iv) as a result, the Company’s public statements were materially false and misleading at all relevant times.