Vanda presented arguments to support its belief that iloperidone's benefit risk profile, as it was characterized in over 3,000 patients, suggests that iloperidone may be a useful agent for patients with schizophrenia.
Vanda has now agreed to provide a complete response to the FDA, in order
to address the concerns raised by the FDA in their
ABOUT VANDA PHARMACEUTICALS INC.:
Vanda Pharmaceuticals Inc. is a biopharmaceutical company focused on the development and commercialization of clinical-stage product candidates for central nervous system disorders. For more on Vanda Pharmaceuticals Inc., please visit http://www.vandapharma.com.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
Various statements in this release are 'forward-looking statements' under
the securities laws. Words such as, but not limited to, 'believe,' 'expect,'
'anticipate,' 'estimate,' 'intend,' 'plan,' 'targets,' 'likely,' 'will,'
'would,' and 'could,' and similar expressions or words, identify forward-
looking statements. Forward-looking statements are based upon current
expectations that involve risks, changes in circumstances, assumptions and
uncertainties. Vanda is at an early stage of development and may not ever
have any products that generate significant revenue. Important factors that
could cause actual results to differ materially from those reflected in the
company's forward-looking statements include, among others: delays in the
completion of Vanda's clinical trials; a failure of Vanda's product candidates
to be demonstrably safe and effective; Vanda's failure to obtain regulatory
approval for its products or to comply with ongoing regulatory requirements; a
lack of acceptance of Vanda's product candidates in the marketplace, or a
failure to become or remain profitable; Vanda's inability to obtain the
capital necessary to fund its research and development activities; Vanda's
failure to identify or obtain rights to new product candidates; Vanda's
failure to develop or obtain sales, marketing and distribution resources and
expertise or to otherwise manage its growth; a loss of any of Vanda's key
scientists or management personnel; losses incurred from product liability
claims made against Vanda; a loss of rights to develop and commercialize
Vanda's products under its license and sublicense agreements and other factors
that are described in the 'Risk Factors' section (Part II, Item 1A) of Vanda's
quarterly report on Form 10-Q for the quarter ended
All written and verbal forward-looking statements attributable to Vanda or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Vanda cautions investors not to rely too heavily on the forward-looking statements Vanda makes or that are made on its behalf. The information in this release is provided only as of the date of this release, and Vanda undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
SOURCE Vanda Pharmaceuticals Inc.