Deadline
Passed
Lead Plaintiff Deadline: March 20, 2023
(i) Y-mAbs misrepresented the U.S. Food and Drug Administration’s (“FDA”) willingness to approve omburtamab, the Company’s lead product candidate, for marketing based on the existing clinical trials; (ii) the Company misrepresented that progress was being made that would align with the FDA’s requirements to demonstrate substantial evidence of effectiveness, sufficient for approval of omburtamab, through adequate and well-controlled studies; (iii) the FDA had repeatedly advised Y-mAbs that it was unlikely to grant approval for the marketing of omburtamab; and (iv) Y-mAbs had elected to submit the March 31, 2022 Biologics License Application prior to reaching agreement with the FDA on the content of the application.