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Mukai et al

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Additionally, FDA cited Zoll for failing to follow MDR reporting requirements, including incidents where there may have been a reasonable concern of a product malfunction, and the company didn't notify the agency within the required timeframe

A Phase 2 Open-Label, Multicenter, Dose Optimization Clinical Study of the Safety, Tolerability, and Pharmacokinetic (PK) and Pharmacodynamic (PD) Profiles of Cfi-400945 As a Single Agent or in Combination with Azacitidine or Decitabine in Patients with Acute Myeloid Leukemia, Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia (TWT-202)