8-K 1 f75574e8-k.txt FORM 8-K 1 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: September 4, 2001 Date of earliest event reported: August 31, 2001 AVIRON (Exact name of registrant as specified in its charter) DELAWARE (State or other jurisdiction of incorporation) 0-20815 77-0309686 (Commission File No.) (IRS Employer Identification No.) 297 N. BERNARDO AVENUE MOUNTAIN VIEW CALIFORNIA 94043 (Address of principal executive offices and zip code) Registrant's telephone number, including area code: (650) 919-6500 2 ITEM 5. OTHER EVENTS. On September 3, 2001, we issued a press release announcing receipt of a complete response letter on August 31, 2001 from the U.S. Food and Drug Administration relating to our Biologics License Application submitted on October 31, 2000 for licensure of FluMist(TM). A copy of the press release is attached as an exhibit hereto and incorporated by reference herein in its entirety. ITEM 7. EXHIBITS. Exhibit 99.1 Press Release, dated September 3, 2001, entitled "Aviron Receives Complete Response Letter Following FDA Review of FluMist(TM) BLA" 3 SIGNATURE 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, hereunto duly authorized. AVIRON Dated: September 4, 2001 By: /s/ C. Boyd Clarke ----------------------------------- C. Boyd Clarke Chairman, President and Chief Executive Officer 4 INDEX TO EXHIBITS Exhibit 99.1 Press Release, dated September 3, 2001, entitled "Aviron Receives Complete Response Letter Following FDA Review of FluMist(TM) BLA"