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Guilford gets non-approvable letter for Gliadel (Reuters Securities) Guilford Pharmaceuticals Inc. said on Wednesday that it has received a non-approvable letter from U.S. regulators for its Gliadel wafer to treat patients with newly diagnosed brain cancer. - Mar 20 10:02 AM ET


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Website: http://biz.yahoo.com/rf/020320/n20338384_1.html

Posted on: 03/21/2002

Guilford gets non-approvable letter for Gliadel

BALTIMORE, March 20 (Reuters) - Guilford Pharmaceuticals Inc. (NasdaqNM:GLFD - news) said on Wednesday that it has received a non-approvable letter from U.S. regulators for its Gliadel wafer to treat patients with newly diagnosed brain cancer.

The company, whose stock fell more than 12 percent in early trading, said it will continue to sell the drug for its other indications. In 1996, the FDA approved Gliadel for use as an adjunct to surgery in patients with recurring brain tumors.

The supplemental New Drug Application was based on data from a Phase III, randomized, double-blind, placebo-controlled study conducted at 38 centers in 14 countries, involving 240 patients undergoing initial surgery for malignant brain cancer. The primary endpoint in the study was overall survival in all patients enrolled in the trial.

Guilford's analysis of survival indicated that, relative to the placebo group, the Gliadel wafer group had a hazard ratio of 0.71, meaning a 29 percent reduction in the risk of dying during the trial.

However, the FDA's analysis of survival in the trial indicated that, relative to the placebo group, the Gliadel wafer group had a hazard ratio of 0.77, meaning a 23 percent reduction in the risk of dying during the trial, which failed to reach a statistically significant level, according to Guilford, citing the FDA's letter.



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