Current Report Filing (8-k)
September 08 2016 - 9:18AM
Edgar (US Regulatory)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT
TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): September 8, 2016
CLOVIS ONCOLOGY, INC.
(Exact name of Registrant as specified in its charter)
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Delaware
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001-35347
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90-0475355
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(State or other jurisdiction of
incorporation or organization)
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(Commission
File Number)
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(I.R.S. Employer
Identification No.)
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5500 Flatiron Parkway, Suite 100
Boulder, Colorado
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80301
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(Address of principal executive offices)
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(Zip code)
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(303) 625-5000
(Registrants telephone number including area code)
N/A
(Former name and
former address, if changed since last report)
Check the appropriate box below
if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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The Food and Drug Administration (FDA) has notified Clovis
Oncology, Inc. (the Company) that FDA is not currently planning to hold an advisory committee meeting to discuss the Companys New Drug Application for rucaparib. As previously announced by the Company, FDA has accepted the
Companys NDA for accelerated approval of rucaparib and granted priority review status to the application with a Prescription Drug User Fee Act (PDUFA) date of February 23, 2017.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned, thereunto duly authorized.
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CLOVIS ONCOLOGY, INC.
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By:
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/s/ Paul E. Gross
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Name:
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Paul E. Gross
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Title:
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Senior Vice President & General Counsel
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Dated: September 8, 2016
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