Shares of MGI Pharma and SuperGen slid this morning after they announced that the FDA issued an "approvable" letter for Dacogen -- their new treatment for bone marrow disorders -- but would need more data before the agency could give it a green light. MGI Pharma bought the treatment from SuperGen last year, leaving SuperGen with a 30 percent royalty deal. The FDA's letter, though, did state that the drug could be approved after an analysis to determine how many patients currently in a trial received a blood transfusion. That data could be delivered in the fourth quarter.
"We are working diligently to complete the requested analysis of data and provide this information to the FDA as early as possible during the fourth quarter," stated Lonnie Moulder, president and CEO of MGI Pharma. "The MGI Pharma commercial organization is prepared to launch Dacogen injection upon final FDA approval."
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