According to the lawsuit, defendants throughout the Class Period made false and/or misleading statements and/or failed to disclose that:
- the sulopenem New Drug Application (“NDA”) lacked sufficient data to support approval for the treatment of adult women with uncomplicated urinary tract infections (“uUTIs”) caused by designated susceptible microorganisms proven or strongly suspected to be non-susceptible to a quinolone;
- accordingly, it was unlikely that the U.S. Food and Drug Administration (“FDA”) would approve the sulopenem NDA in its current form;
- defendants downplayed the severity of issues and deficiencies associated with the sulopenem NDA; and
- as a result, Iterum’s public statements were materially false and misleading at all relevant times.
No Class Has Been Certified. Until a class is certified, you are not represented by counsel unless you retain one. You may select counsel of your choice. You may also remain an absent class member and do nothing at this point. An investor’s ability to share in any potential future recovery is not dependent upon serving as lead plaintiff.
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