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Salix doesn't expect to disclose details of FDA meeting until August

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Salix Pharmaceuticals CEO Carolyn Logan said today that the company won't comment on its recent meeting with federal regulators until it releases its second quarter earnings in August.

Logan, speaking at a Wells Fargo health care conference in Boston, said the company wants to wait until it gets the final minutes from the meeting.

"So we are hopeful that on August 8th we'll be able to give you our thoughts around that meeting, and of course if anything is finalized prior to that, we will press release it," she said.

Salix officials met Monday with Food and Drug Administration officials about the agency's decision to delay approval of the company's drug Xifaxan for treatment of irritable bowel syndrome.

In February, Salix received a Complete Response Letter from the FDA regarding its IBS application, which would be worth billions to the company. That's what the agency issues when its review process is complete and a drug application is not ready for approval.

The delay could mean the FDA will request a long-term study of the drug that could take several years to complete.

Salix officials believe such a study is not necessary.

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About the blogger

Business reporter David Bracken came to the N&O in 2004. He covers commercial and residential real estate. Contact David at 919-829-4548 or e-mail him.
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