According to the lawsuit, defendants throughout the Class Period made false and/or misleading statements and/or failed to disclose that:
- deficiencies existed with respect to the manufacturing process of DefenCath, a purported novel antibacterial and antifungal solution designed to prevent costly and dangerous catheter-related bloodstream infections (“CRBSIs”), and/or at the facility responsible for manufacturing DefenCath;
- in light of the foregoing deficiencies, the U.S. Food and Drug Administration (“FDA”) was unlikely to approve the DefenCath New Drug Application (“NDA”) for CRBSIs in its present form;
- defendants had downplayed the true scope of the deficiencies regarding DefenCath’s manufacturing process and/or at the facility responsible for manufacturing DefenCath; and
- as a result, the Company’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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