Advanced Magnetics' GastroMark approval "imminent," CEO tells Oppenheimer conference.
ADVANCED MAGNETICS GASTROMARK APPROVAL IS "IMMINENT," CEO Jerome Goldstein told an Oppenheimer & Co. health care conference in New York City Oct. 30. NDA 20-410 for the oral gastrointestinal magnetic resonance imaging agent became "approvable" at FDA May 7 ("The Pink Sheet" July 22, In Brief). FDA refused to file Advanced Magnetics' original GastroMark NDA in 1992 for lack of a disease-specific indication; the same NDA, without a disease-specific indication, was resubmitted in November 1993.
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