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FDA extends review time for Genta's appeal

Genta is going to have to wait a little longer before it gets final word on its appeal of the FDA's rejection of Genasense. The feds were supposed to act by the end of last year, but Genta says now that a decision won't be made until sometime in the current quarter. Genta had filed for approval to use Genasense with chemotherapy in patients with relapsed or refractory chronic lymphocytic leukemia.

- check out the release on the appeal

Related Articles:
FDA rejects Genasense. Report
Advisory committee rejects Genta cancer drug. Report
Genasense hits primary endpoint in late-stage cancer trial. Report


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