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EXEL > SEC Filings for EXEL > Form 8-K on 29-Aug-2012All Recent SEC Filings

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Form 8-K for EXELIXIS INC


29-Aug-2012

Other Events


Item 8.01. Other Events.

On August 29, 2012, Exelixis, Inc. (the "Company") was notified by the Food and Drug Administration (the "FDA") that the Company's new drug application ("NDA") for cabozantinib as a treatment for patients with progressive, unresectable, locally advanced, or metastatic medullary thyroid cancer has been removed from the agenda for the November 8 and November 9, 2012 meeting of the FDA's Oncologic Drugs Advisory Committee ("ODAC"). As a result, the Company does not anticipate a discussion of the NDA by ODAC. The previously announced Prescription Drug User Fee Act (PDUFA) action date remains November 29, 2012.


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