Genta, Inc (fka GNTAQ)

[navycmdr]

Form 8-K for GENTA INC DE/

9-Mar-2009 Other Events

Item 8.01 Other Events.

On March 6, 2009, Genta Incorporated, (the Company), announced that the Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) has decided that available data are not adequate to support approval of Genasense� (oblimersen sodium) Injection for treatment of patients with relapsed or refractory chronic lymphocytic leukemia (CLL). In a decision issued in response to an appeal filed by Genta in December 2008, CDER concluded that new information submitted by the Company in its amended New Drug Application (NDA) was insufficient, and the Agency has recommended conducting a confirmatory clinical trial.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.
Exhibit
Number Description
99.1 Press Release of the Company dated March 6, 2009