According to the Complaint, the Company made false and misleading statements to the market. Y-mAbs repeatedly misled investors about its meetings with the FDA, claiming that it was making progress in demonstrating the effectiveness and efficacy of its drug candidate, omburtamab. What was unknown to investors was that the FDA had repeatedly advised Y-mAbs that the treatment of effect of omburtamab cannot be objectively established or quantified based on a comparison between Study 03-133 and an external cohort comprised of data from the Central German Childhood Cancer Registry (CGCCR) database because of substantial differences in the patient populations, and the absence of tumor response data, and that Study 101 was neither sufficiently advanced nor indicative of efficacy to justify approval. Further, Y-mAbs failed to advise investors that it had elected to submit the March 31, 2022 BLA prior to reaching agreement with the FDA on the content of the application. Based on these facts, the Company’s public statements were false and materially misleading throughout the class period. When the market learned the truth about Y-mAbs, investors suffered damages.
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