According to the lawsuit, defendants throughout the Class Period made false and/or misleading statements and/or failed to disclose that:
- the Investigational New Drug Application for SkinTE, a tissue product purportedly used to repair, reconstruction, replacement, and supplementation of skin in patients for the treatment of acute or chronic wounds, burns, surgical reconstruction events, scar revision, or removal of dysfunctional skin grafts, as well as contract research services, (the “SkinTE IND”), was deficient with respect to certain Chemistry, Manufacturing, and Control (CMC) items;
- as a result, it was unlikely that the U.S. Food and Drug Administration (“FDA”) would approve the SkinTE IND in its current form;
- accordingly, the Company had materially overstated the likelihood that the SkinTE IND would obtain FDA approval; 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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