In September, the company reported that the FDA had opened the investigational new drug application (IND) for Corlux for the treatment of endogenous Cushing's syndrome, which allowed it to initiate this 50-patient open label study. In the communication regarding the opening of the IND, the FDA indicated that a single study may provide a reasonable basis for the submission of a new drug application for the treatment of endogenous Cushing's syndrome.
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