CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This prospectus and the documents incorporated by reference in this prospectus contain forward-looking statements within the meaning of Section 27A of the Securities Act, and Section 21E of the Exchange Act. We have based these forward-looking statements on our current expectations and projections about future events. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “will,” “would” or the negative of such terms or other similar expressions. All statements, other than statements of present or historical fact included in this prospectus, our future financial performance, strategy, expansion plans, future operations, future operating results, estimated revenues, losses, projected costs, prospects, plans and objectives of management are forward-looking statements. Any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements.
Forward-looking statements in this prospectus and the documents incorporated by reference in this prospectus may include, for example, statements about:
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our ability to adapt our initial commercial and pricing models, plans and strategies to the U.S. regulatory environment, and its impact on our ability to develop, maintain and leverage our commercialization strategy;
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additional clinical trials for our pipeline candidates and the effect on our pricing and commercialization strategy;
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our mission, commercial model and pricing strategy;
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the success, costs and timing of our product development activities;
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our ability to obtain and maintain regulatory approval for our products, and any related restrictions and limitations on any approved product;
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our ability to locate and acquire complementary products or product candidates and integrate those into our business;
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our ability to maintain our existing or enter into additional license agreements;
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our ability to maintain our existing or enter into additional drug engineering collaborations;
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our ability to maintain our existing or enter into additional manufacturing agreements;
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our ability to compete with other companies currently marketing or engaged in the development of innovative drug candidates, many of which have greater financial and marketing resources than we do;
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the size and growth potential of the markets for our products, and our ability to serve those markets, either alone or in partnership with others;
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changes in applicable laws or regulations;
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our ability to raise capital in the future;
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our estimates regarding expenses, future revenue, capital requirements and needs for additional financing;
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our financial performance;
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our ability to compete effectively in a competitive industry;
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our ability to protect and enhance our corporate reputation and brand;
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expectations concerning our relationships and actions with third parties;
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potential liquidity and trading of our securities;
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our ability to attract and retain qualified directors, officers, employees and other key personnel;