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selfactualize

Re: ActivClient post# 45063

Tuesday, 06/29/2010 3:35:41 AM

Tuesday, June 29, 2010 3:35:41 AM

Post# of 58465
FDA Appeal Decision Indicates That Genasense(R) Approval In Chronic Lymphocytic Leukemia Will Require Additional Confirmatory Trial

http://www.medicalnewstoday.com/articles/141539.php

....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...........
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