Genta Incorporated (Nasdaq: GNTA)’s proposal for a confirmatory trial of Genasense® (oblimersen sodium) Injection in patients with chronic lymphocytic leukemia (CLL) has completed USFDA Special Protocol Assessment (SPA).
This means that the USFDA has agreed with the proposed trial design and planned analyses to fulfill commitments that may be required under provisions related to SubPart H regulations regarding accelerated approval.
Genta Inc. already filed a New Drug Application (NDA) under SubPart H for Genasense® plus chemotherapy (currently under USFDA review) which, under the Prescription Drug User Fee Act (PDUFA) has a target action date for a marketing approval decision by October 29, 2006.
Read more details from Genta Incorporated.
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