According to the lawsuit, during the Class Period, defendants made false and/or misleading statements and/or failed to disclose that:
- Actinium’s data from Sierra Trial was unlikely to satisfy the U.S. Food and Drug Administration’s (“FDA”) guidelines for the acceptance and approval of Actinium’s Iomab-B Biologics License Application (“BLA”);
- the additional analyses, including long-term follow-ups that purportedly demonstrated a trend towards improved Overall Survival (“OS”) that Actinium provided to the FDA in an attempt to mitigate the Sierra Trial’s poor OS data were unlikely to satisfy the FDA’s guidelines for the acceptance and approval of Actinium’s Iomab-B BLA;
- as a result, the FDA would likely refuse to review the Iomab-B BLA or, if it did consider that BLA, that the application in its current form was unlikely to be approved; and
- as a result, defendants’ positive statements about Actinium’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis.
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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