57 • identifying, recrui r ting, integrating, retaining and motivating additional employees; • managing our internal development effo f rts effe f ctively, including the clinical and FDA review process for our current and future product candidates, while complying with our contractua t l obligations to contractors and other third parties; • expanding our operational, financial and management controls, reporting systems and procedur d es; and • managing increasing operational and managerial complexity. Our future financial performance and our ability to continue to develop and, if approved, commercialize our product candidates will depend, in part, on our ability to effe f ctively manage any future growth. Our management may also have to divert a disproportionate amount of its attention away from day-to-day activities in order to manage these growth activities. We currently rely, and for the foreseeable future will continue to rely, in subs u tantial part on certain independent organizations, advisors and consultants to provide certain services. There can be no assurance that the services of these independent organizations, advisors and consultants will continue to be availabl a e to us on a timely basis when needed, or that we can find qualifie f d replacements. In addition, if we are unabl a e to effe f ctively manage our outsourced activities or if the quality or accuracy of the services provided by consultants is compromised for any reason, our clinical trials may be extended, delayed, or terminated, and we may not be able to obtain regulatory r approval of our product candidates or otherwise advance our business. There can be no assurance that we will be able to manage our existing consultants or find other competent outside contractors and consultants on economically reasonabl a e terms, if at all. If we are not able to effe f ctively expand our organization by hiring new employees and expanding our groups of consultants and contractors, we may not be able to successful f ly implement the tasks necessary to further develop our product candidates and, accordingly, may not achieve our research, development, and commercialization goals. If we engage in acquisitio t ns,s in-lic l ensing i or stra t tegi e c partnersh r ips, this may a increase our capi a ta i l requirements,s dilu i te our stoc t kholde l rs, cause us to incur debt or assume contin t gent liabilitie i s and subject us to othe t r risk i s. k We may engage in various acquisitions and strategic partnerships in the future, including licensing or acquiring complementary r products, intellectua t l property rights, technologies or businesses. Any acquisition or strategic partnership may entail numerous risks, including: • increased operating expenses and cash requirements; • the assumption of indebtedness or contingent liabi a lities; • the issuance of our equity securities which would result in dilution to our stockholders; • assimilation of operations, intellectua t l property, products and product candidates of an acquired company, including difficulties associated with integrating new personnel; • the diversion of our management’s attention from our existing product candidates and initiatives in pursuing such an acquisition or strategic partnership; • retention of key employees, the loss of key personnel, and uncertainties in our ability to maintain key business relationships; • risks and uncertainties associated with the other party to such a transaction, including the prospects of that party and their existing products or product candidates and regulatory r approvals; and • our inability to generate revenue from acquired intellectua t l property, technology and/or products suffic f ient to meet our objectives or even to offs f et the associated transaction and maintenance costs. In addition, if we undertake such a transaction, we may incur large one-time expenses and acquire intangible assets that could result in signific f ant future amortization expense.

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