FDA 3 Genta 0 Genta Receives Complete Response Letter from FDA to Amended Application of Genasense® in Patients with Chronic Lymphocytic Leukemia Tuesday December 2, 5:15 pm ET BERKELEY HEIGHTS, N.J.--(BUSINESS WIRE)--Genta Incorporated (OTCBB: GNTA.OB - News) today announced that the Company has received a complete response letter from the Office of Oncology Drug Products (OODP) at the Food and Drug Administration (FDA) regarding the Company’s amended New Drug Application (NDA) for the use of Genasense® plus chemotherapy in patients with chronic lymphocytic leukemia (CLL). In its letter, OODP indicated that the Division cannot approve the NDA in its present form and suggested the need for an additional clinical study.
