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, Defendants made false and/or misleading statements and/or failed to disclose that: (i) quality control deficiencies existed at the Company’s manufacturing facility for DAXI; (ii) the foregoing deficiencies decreased the likelihood that the FDA would approve the DAXI BLA in its current form; (iii) accordingly, it was unlikely that the DAXI BLA would obtain FDA approval within the timeframe the Company had represented to investors; and (iv) as a result, the Company’s public statements were materially false and misleading at all relevant times.