Genta, Inc (fka GNTAQ)

[The Holder]

Genasense has been a "Fast Track" status drug since 2005, so the FDA clearly sees the need for an antisense technology.

BERKELEY HEIGHTS, N.J., June 30, 2005 -- Genta Incorporated today announced that the Company has initiated submission of a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) seeking marketing approval of Genasense (oblimersen sodium) Injection, its lead anticancer compound. The NDA seeks accelerated approval for the use of Genasense in combination with fludarabine plus cyclophosphamide for the treatment of patients with chronic lymphocytic leukemia (CLL) who have previously received fludarabine. Genasense has received Fast Track designation by FDA in CLL, meaning that the indication represents an unmet medical need. Fast Track designation enables the Company to submit the NDA on a "rolling" basis as specific sections are completed. Genta has submitted the initial section, and the Company anticipates that the NDA will be completed within 6 months. Genasense has also received designation as an Orphan Drug in CLL, which provides for a period of marketing exclusivity, certain tax benefits, and exemption from certain fees at the time of NDA submission. Accelerated approval will require the Company to conduct a confirmatory study, and Genta plans to discuss the design of that study with FDA.

http://www.drugs.com/nda/genasense_050630.html