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The U.S. Food and Drug Administration (FDA) has some questions for Genzyme Corp. (NASDAQ: GENZ) regarding trial data for its leukemia drug, Clolar. Because Genzyme didn't follow the FDA's recommendations in conducting its main study of Clolar, the regulatory agency is reluctant to make a decision on the basis of the trial results.
In 2007, FDA staff advised Genzyme to conduct a randomized study in which participants receiving Clolar would be compared against a set of patients not receiving the drug. However, the drug company's primary tests did not include a control group; instead, the treatment was tested only on elderly patients with acute myeloid leukemia (AML).
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