The U.S. regulatory body declined to approve the drug as a monotherapy on the basis of the submitted data due to shortcomings observed in the documentation and validation of certain quality testing methods. Gilead is working towards resubmission of the new drug application (:NDA). Apart from the European approval for Vitekta, Gilead was in the news when it announced encouraging data from a phase III study (116) on its oncology candidate idelalisib in previously-treated CLL adults. Chemotherapy was not suitable for the patients. We remind investors that Gilead stopped the study earlier than scheduled on the basis of the recommendation of an independent Data Monitoring Committee (:DMC) in Oct 2013. The DMC's recommendation followed an interim analysis of the study where the candidate exhibited a positive risk-benefit profile. Gilead is currently in discussion with the FDA regarding the submission of a NDA on idelalisib for treating CLL patients.