he 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) the ROLONTIS manufacturing facility maintained deficient controls and/or procedures; (ii) the foregoing deficiencies decreased the likelihood that the FDA would approve the ROLONTIS BLA in its current form; (iii) Spectrum had therefore materially overstated the ROLONTIS BLA’s approval prospects; and (iv) as a result, the Company’s public statements were materially false and misleading at all relevant times. On August 6, 2021, Spectrum announced receipt of a Complete Response Letter (“CRL”) from the FDA regarding the ROLONTIS BLA. The CRL cited deficiencies related to manufacturing and indicated that a reinspection of the Company’s manufacturing facility will be necessary. On this news, Spectrum’s stock price fell $0.70 per share, or 21.54%, to close at $2.55 per share on August 6, 2021.