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What: Shares of Salix Pharmaceuticals
So what: Salix already sells Xifaxan to treat travelers' diarrhea and hepatic encephalopathy, but to boost sales significantly, applied last year to have it approved as a treatment for non-constipation irritable bowel syndrome, as well. With at least 30 million in the U.S. suffering from irritable bowel syndrome, Wall Street naturally had some pretty high expectations for the expanded use.
Now what: Salix simply remains far too risky for most Fools. Analysts are now saying that the FDA could delay approval for as much as two to three years and cost the company tens of millions if management elects to run an additional trial. Salix will decide what to do next after it officially receives the FDA's Complete Response Letter, but for investors, the decision to stay away should be an easy one.
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