According to the lawsuit, throughout the Class Period, Dfendants made false and/or misleading statements and/or failed to disclose that:
- there was a lack of substantial evidence supporting ONS-5010 as a treatment for wet age-related macular degeneration (“wet AMD”);
- Outlook and/or its manufacturing partner had deficient chemistry manufacturing and controls (“CMC”) and other manufacturing issues for ONS-5010, which remained unresolved at the time the ONS-5010 biologics license application (“BLA”) was resubmitted to the U.S. Food and Drug Administration (“FDA”);
- as a result of all the foregoing, the FDA was unlikely to approve the ONS-5010 BLA in its present form;
- accordingly, ONS-5010’s regulatory and commercial prospects were overstated; and
- as a result, Outlook’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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