Forward
looking statements
This
presentation contains forward-looking statements within the meaning
of the “safe harbor” provisions of the Private
Securities Litigation
Reform Act of
1995. The forward-looking statements contained in this presentation
include statements about future financial and operating
results,
and risks and
uncertainties that could affect Cell Therapeutic Inc.’s
(“CTI”) products under development. These statements
are based on
management’s
current expectations and beliefs and are subject to a number of
factors and uncertainties that could cause actual results to
differ
materially from
those described in the forward-looking statements. These statements
are not guarantees of future performance, involve
certain
risks,
uncertainties and assumptions that are difficult to predict, and
are based upon assumptions as to future events that may not prove
accurate.
Therefore,
actual outcomes and results may differ materially from what is
expressed herein. In any forward-looking statement in which
CTI
expresses an
expectation or belief as to future results, such expectation or
belief is expressed in good faith and believed to have a
reasonable
basis, but
there can be no assurance that the statement or expectation or
belief will result or be achieved or accomplished.
The following
factors, among others, could cause actual results to differ
materially from those described in the forward-looking statements:
risks
associated with
preclinical, clinical and sales and marketing developments in the
biopharmaceutical industry in general and in particular
including,
without
limitation, the potential failure of Tosedostat to prove safe and
effective (including complete and overall response rates) for the
treatment of
blood related
cancers and selected tumors as determined by the U.S. Food and Drug
Administration (the “FDA”) or other regulatory agencies
in
the territories
where CTI has exclusive rights, that the FDA may not accept the
proposed clinical trial design of Tosedostat and/or may
request
additional
clinical trials, that clinical trials may not demonstrate the
safety and effectiveness of Tosedostat, that CTI cannot predict or
guarantee
the pace or
geography of enrollment of clinical trials of Tosedostat, including
whether or not the majority of the patients will be enrolled in the
U.S.,
that CTI cannot
predict or guarantee the outcome or results of clinical trials of
Tosedostat, that a new drug application and/or marketing
authorization
application for Tosedostat may not be approved as early as 2013,
that even if approved, CTI may not achieve the anticipated
sales,
that CTI cannot
predict or guarantee whether the exclusive marketing license and
co-development agreement with Chroma Therapeutics Ltd
(the
“Agreement”)
will strengthen CTI’s business, financial condition,
operating re
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