Genta, Inc (fka GNTAQ)

[STLCardinalsFan]

GREAT NEWS!!!

Phase 3/Chronic Lymphocytic Leukemia (CLL)/NDA Status : Genta has appealed a prior “non-approvable” decision on the Genasense ®
New Drug Application (NDA) for patients with relapsed/refractory CLL. The appeal is now pending a decision by FDA’s Center for Drug
Evaluation and Research (CDER). The pivotal randomized trial achieved its primary endpoint, which was to significantly increase the proportion
of patients who achieved complete remission by adding Genasense ® to standard chemotherapy compared with patients treated with
chemotherapy alone. With 5-years of followup, all patients who achieved a major response (either complete or partial remission) on the
Genasense ® treatment arm achieved superior survival compared with responders treated with chemotherapy alone. A decision from CDER is
expected in the current quarter.