Fibrocell Science, Inc. Receives FDA Complete Response Letter Regarding azficel-T for Wrinkles
21 Diciembre 2009 - 6:43PM
PR Newswire (US)
EXTON, Pa., Dec. 21 /PRNewswire-FirstCall/ -- Fibrocell Science,
Inc. (OTC Bulletin Board: FCSC) announced today that it has
received a Complete Response letter from the U.S. Food and Drug
Administration (FDA) related to the Biologics License Application
(BLA) for azficel-T, an autologous cell therapy for the treatment
of moderate to severe nasolabial fold wrinkles in adults. A
Complete Response letter is issued by the FDA's Center for
Biologics Evaluation and Research (CBER) when the review of a file
is completed and additional data are needed prior to approval. The
Complete Response letter requested that Fibrocell Science provide
data from a histopathological study on biopsied tissue samples from
patients following injection of azficel-T. The letter also
requested finalized Chemistry, Manufacturing and Controls (CMC)
information regarding the manufacture of azficel-T as follow-up to
discussions that occurred during the BLA review period, as well as
revised policies and procedures regarding shipping practices, and
proposed labeling. "We are pleased with the review and will work
closely with the FDA to complete the histopathology study and
provide all of the requested data as quickly as possible," said
Declan Daly, Fibrocell Science, Inc. interim chief executive
officer. About Fibrocell Science, Inc. Fibrocell Science, Inc.
(OTC:FCSC) (BULLETIN BOARD: FCSC) is a biotechnology company
focused on the development of regenerative cell therapy for
aesthetic, medical and scientific applications. Fibrocell Science
is committed to advancing the scientific, medical and commercial
potential of autologous skin and tissue, as well its innovative
cellular processing technology and manufacturing excellence. For
additional information, please visit
http://www.fibrocellscience.com/. Forward Looking Statements All
statements in this press release that are not based on historical
fact are "forward-looking statements" within the meaning of the
Private Securities Litigation Reform Act of 1995 and the provisions
of Section 27A of the Securities Act of 1933, as amended, and
Section 21E of the Securities Exchange Act of 1934, as amended.
Forward-looking statements in this press release include, without
limitation, the ability of the Company to complete the
histopathology study and provide to the FDA the requested data on a
timely basis. While management has based any forward-looking
statements contained herein on its current expectations, the
information on which such expectations were based may change. These
forward-looking statements rely on a number of assumptions
concerning future events and are subject to a number of risks,
uncertainties, and other factors, many of which are outside of the
Company's control, that could cause actual results to materially
differ from such statements. Such risks, uncertainties, and other
factors include, but are not necessarily limited to, those set
forth under Item 1A "Risk Factors" in the Company's Annual Report
on Form 10-K for the year ended December 31, 2008, as updated in
"Item 1A. Risk Factors" in the Company's Quarterly Reports on Form
10-Q filed since the annual report. The Company operates in a
highly competitive and rapidly changing environment, thus new or
unforeseen risks may arise. Accordingly, investors should not place
any reliance on forward-looking statements as a prediction of
actual results. The Company disclaims any intention to, and
undertakes no obligation to, update or revise any forward-looking
statements. Readers are also urged to carefully review and consider
the other various disclosures in the Company's public filings with
the SEC. DATASOURCE: Fibrocell Science, Inc. CONTACT: Mike Beyer of
Sam Brown Inc., +1-773-463-4211, Web Site:
http://www.fibrocellscience.com/
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