Published in Drug Law Weekly, March 6th, 2007
Company will file appeal for Genasense(R) NDA in CLL
Expanded Access Program to continue in U.S. during appeal
Completed response to EMEA 180-day review questions for MAA in melanoma; formal CHMP opinion expected within 90 days
Follow-on Genasense/melanoma trial initiated using key biomarker
Intermittent Genasense dosing shown effective in preclinical models; clinical trial of intermittent short IV and...
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Source: Drug Law Weekly (2007-03-06)
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