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) data supporting bluebird’s BLA submission for LentiGlobin for SCD was insufficient to demonstrate drug product comparability; (ii) Defendants downplayed the foreseeable impact of disruptions related to the COVID-19 pandemic on the Company’s BLA submission schedule for LentiGlobin for SCD, particularly with respect to manufacturing; (iii) as a result of all the foregoing, it was foreseeable that the Company would not submit the BLA for LentiGlobin for SCD in the second half of 2021; and (iv) as a result, the Company’s public statements were materially false and misleading at all relevant times. On November 4, 2020, post-market, bluebird disclosed that it would no longer apply for FDA approval of its LentiGlobin product as a treatment for SCD in the second half of 2021 as expected. Instead, citing “feedback” from the FDA requiring the Company to provide additional data “to demonstrate drug product comparability” for LentiGlobin for SCD, “alongside COVID-19 related shifts and contract manufacturing organization COVID-19 impacts,” bluebird adjusted its submission timing to late 2022. On this news, bluebird’s stock price fell $9.72 per share, or 16.6%, to close at $48.83 per share on November 5, 2020.