The Company would doubtless need to restructure and scale back its workforce because of the deficiency. Spero submitted insufficient information to the FDA as a part of its Tebipenem HBr NDA. Based on these information, the Company’s public statements were false and materially misleading throughout the class period. It was unlikely that the NDA would receive FDA approval based on this deficiency. When the market realized the truth about Spero, investors suffered damages.
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