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Bidikian A, Basu S, PhD, Zhong H, Atluri H, MD, Zarka J, MD, Andreeff M , MD, PhD, Sasaki K, MD, Jabbour E, MD, Cortes JE, MD, Sharma P, MD, PhD, Issa GC

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While the agency has cited "significant safety risks" as the rationale behind this categorization, it has not divulged the specific methodology or details pertaining to the identified risks