Forward
Looking Statements 2
This presentation contains forward-looking statements, including, but not limited to,
statements related to future financial results, potential proceeds under the Grunenthal
agreement, the process and timing of anticipated future development of AcelRxs product
candidates, including Zalviso, the NDA submission and the CRL, the Type A meeting held with
the FDA to discuss the CRL, AcelRxs
plans
to
address
the
issues
raised
in
the
CRL,
and
anticipated
resubmission
of
the
Zalviso
NDA
to
the
FDA,
including
the scope
of the resubmission and the timing of the resubmission and FDA review time, the impact, if
any, of the FDAs review of the amendments to the Zalviso NDA that were not
previously reviewed, planned initiation of the Phase 3 clinical trial for ARX-04,
and the therapeutic and commercial potential of AcelRx Pharmaceuticals' product
candidates, including Zalviso. These forward-looking statements are based on AcelRx
Pharmaceuticals' current expectations and inherently involve significant risks and uncertainties.
AcelRx Pharmaceuticals' actual results and the timing of events could differ materially from
those anticipated in such forward-looking statements as a result of these risks and
uncertainties, which include, without limitation, risks related to: AcelRx Pharmaceuticals'
ability to receive regulatory approval for Zalviso; any delays or inability to obtain and
maintain regulatory approval of its product candidates, including Zalviso, in the
United States and Europe; AcelRx's ability to build an effective commercial organization; its ability
to receive any milestones or royalty payments under the Grunenthal agreement; its ability to
obtain sufficient financing to commercialize Zalviso and proceed with clinical
development of ARX-04; the success, cost and timing of all product development
activities and clinical trials, including the planned Phase 3 ARX-04 trial; the market
potential for its product candidates; the accuracy of AcelRxs estimates regarding
expenses, capital requirements and needs for financing; and other risks detailed in the "Risk Factors" and
elsewhere
in
AcelRx
Pharmaceuticals'
U.S.
Securities
and
Exchange
Commission
filings
and
reports,
including
its
Quarterly
Report
on
Form 10-Q filed with the SEC on November 10, 2014. AcelRx Pharmaceuticals undertakes no
duty or obligation to update any forward- looking statements contained in this
release as a result of new information, future events or changes in its expectations. |