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Biotech / Medical : GTXi (GTXI)
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From: tnsaf3/5/2009 10:34:14 AM
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GTx says FDA will rule on bone drug by Oct. 30
Thursday March 5, 10:12 am ET
GTx says regulators plan to make ruling on bone drug toremifene by Oct. 30

MEMPHIS, Tenn. (AP) -- GTx Inc. said Thursday that the Food and Drug Administration plans to make a ruling on the company's bone drug toremifene by Oct. 30.

The drug is intended to prevent bone fractures in men who are being treated for prostate cancer by undergoing androgen deprivation therapy. GTx has asked the FDA to approve marketing for 80 mg doses of toremifene.

The FDA chose to conduct a standard review, which takes 10 months from the time the company submits its New Drug Application. A priority review takes six months.

An estimated 186,000 new cases of prostate cancer were diagnosed in 2008, and GTx said 100,000 men start androgen deprivation treatment each year. The treatment tends to weaken bones, and the company said 5 percent to 8 percent of those men suffer a bone fracture.

Shares of GTx fell 13 cents to $8.95 in morning trading Thursday.
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