Genta To Appeal FDA Decision on Genasense for CLL

[Guest guest]

This could be a first .. a second ODAC deliberation on the same application?

It looks as if the appeal will be a closed-door variety at this time.

Genesense is also known as antisense - a drug designed to inhibit bcl-2

expression, administered as a continuous infusion in combination with

chemotherapy. ~ Karl

=Genta To Appeal FDA Decision On New Drug Application For Genasense® In

Patients With Chronic Lymphocytic Leukemia

" We believe our amended application provided evidence that amply documented

the safety and effectiveness of Genasense for patients with CLL, " said Dr.

P. Warrell, Jr., MD, Genta's Chairman and Chief Executive Officer.

" We look forward to promptly meeting with senior FDA leadership to formally

review the key issues of this NDA. "

http://www.medicalnewstoday.com/articles/133015.php