MOUNTAIN VIEW, Calif., Jan. 8 /PRNewswire-FirstCall/ -- Aviron (Nasdaq:
AVIR) today submitted to the U.S. Food and Drug Administration (FDA) a formal
reply to the complete response letter the FDA sent the Company on August 31,
2001 relating to its Biologics License Application for FluMist(TM), Aviron's
investigational intranasal influenza vaccine.
The Company's response provided additional information and clarification
regarding clinical and manufacturing data, as requested by the FDA in the
complete response letter.
Aviron is a biopharmaceutical company based in Mountain View, California,
focused on the prevention of disease through innovative vaccine technology.
This press release contains forward-looking statements. These statements,
which reflect management's current beliefs and expectations, are subject to
risks and uncertainties that may cause actual results to differ materially
from those projected in the forward-looking statements. Factors that could
cause actual results to differ include, but are not limited to, the risk that
the FDA will determine that the Company needs to conduct additional clinical
trials and/or provide additional data in order to obtain licensure, determine
that the Company's manufacturing facilities are not adequate or otherwise
determine that the Company's license application for FluMist(TM) is incomplete
or inadequate to approve the product for marketing to one or more target
populations, and other business risks identified in the Company's Annual
Report on Form 10-K, as amended, for the fiscal year ended December 31, 2000
and other quarterly filings.
Additional information about the company, including recent press releases,
can be located at http://www.aviron.com .
SOURCE Aviron
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Related links:
http://www.aviron.com
Company News On-Call:
http://www.prnewswire.com/comp/114000.html
CONTACT:
Media, John Bluth of Aviron, +1-650-919-3716;
or Camela Stuby of Fleishman-Hillard, +1-212-453-2000, for
Aviron; or Investors, John Bluth, +1-650-919-3716, or Fred
Kurland, +1-650-919-6666, both of Aviron
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