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Home » ANSM Cites ‘Off-Target Effect’ of Compound As Probable Cause of Trial Disaster
ANSM Cites ‘Off-Target Effect’ of Compound As Probable Cause of Trial Disaster
After a French Phase 1 clinical trial in January designed by Portuguese drugmaker Bial Laboratories left one patient dead and another six hospitalized, an Agency for Medicines and Health Products Safety-appointed committee determined that an “off-target effect” of the compound is a probable explanation of the tragedy.