May 2, 2013: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement
Center Date Time Location
CDER May 2, 2013 8:00 a.m. to 5:00 p.m. FDA White Oak Campus
The Great Room (Rm. 1503)
White Oak Conference Center
10903 New Hampshire Avenue
Silver Spring, Maryland
During the morning session, the committee will discuss new drug application (NDA) 204408, with the established name tivozanib capsules, submitted by AVEO Pharmaceuticals, Inc. The proposed indication (use) for this product is for the treatment of advanced renal (kidney) cell carcinoma.
AVEO will be closed during the day. No trading. The vote will normally occur after the market is closed, then aftermarket trading might occur in the issue. Generally the decision - the outcome of the voting, is announced the same day. they'll vote on safety - a lay up, I think we know that. And efficacy - I don't see how there will be a problem there either. I don't know if there will be separate voting as to its use in first line treatment versus second line treatment, or how that question will be addressed.