In the course of our discussions with the FDA, the agency has expressed concern regarding the OS trend and has said that it will review the findings at the time of the NDA filing, as well as during the review of the NDA. They're conducting additional analyses to be included in the NDA submission that demonstrate that the OS data from TIVO-1 are consistent with improved clinical outcomes in RCC patients receiving more than one line of therapy, Analyses that we believe, will directly address this issue. We are continuing to work towards submitting the NDA by the end of the third quarter. However, there is a chance that the additional OS analyses may cause the submission to slip into the fourth quarter.We remain confident in our data supporting tivozanib and first-line RCC and believe that tivozanib represents an important new treatment option for patients with kidney cancer. To further establish the potential for tivozanib, we announced the TAURUS study designed to demonstrate patient preference of tivozanib compared to sunitinib as first-line therapy. We also expect to initiate a breast cancer study with tivozanib later this year.
AVEO Pharmaceuticals Management Discusses Q2 2012 Results - Earnings Call Transcript
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