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Allegations
The filed complaint alleges that Actinium Pharmaceuticals, Inc. made materially false and/or misleading statements and/or failed to disclose that: (1) the Company’s data from the Phase 3 Sierra
trial was unlikely to satisfy the FDA’s guidelines for the acceptance and approval of the Company’s targeted radiotherapy, Iomab-B BLA; (2) the additional analyses, including long-term follow-ups that purportedly demonstrated a trend towards improved Overall Survival that the Company 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 the Company’s Iomab-B BLA; (3) 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 (4), as a result, defendants’ positive statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis.
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