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the implementation of our business model and our plans to develop and commercialize our two lead product candidates and other product candidates, including the potential clinical efficacy and other benefits thereof; |
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our ongoing and future clinical trials for our two lead product candidates and other product candidates, whether conducted by us or by any of our collaborators, including the timing of initiation of these trials, the pace of enrollment, the completion of enrollment, the availability of data from these trials, the expected dates of BLA submission and approval by FDA and equivalent foreign regulatory authorities; |
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our pre-clinical studies and future clinical trials for our other product candidates and our research and development programs, whether conducted by us or by any of our collaborators, including the timing of initiation of these trials, the pace of enrollment, the expected date of completion and of the anticipated results; |
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the timing of and our ability to obtain and maintain regulatory, marketing and reimbursement approvals for our product candidates; |
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the rate and degree of market acceptance and clinical utility of any products for which we receive marketing approval; |
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the pricing and reimbursement levels of our product candidates, if approved; |
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our ability to retain the continued service of our key employees and to identify, hire and retain additional qualified employees, including a direct salesforce in the future; |
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remediation of material weaknesses in our internal control over financial reporting; |
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our commercialization, marketing and manufacturing capabilities and strategy; |
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our intellectual property position and strategy and the scope of protection we are able to establish and maintain for the intellectual property rights covering our product candidates and technology; |
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our ability to identify and develop additional product candidates and technologies with significant commercial potential; |
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our plans and ability to enter into collaborations or strategic partnerships for the development and commercialization of our product candidates and future operations; |
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the potential benefits of any future collaboration or strategic partnerships; |
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our expectations related to the use of our cash and cash equivalents, how long that cash is expected to last, and the need for, timing and amount of any future financing transaction; |
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our financial performance, including our estimates regarding revenues, expenses, capital expenditure requirements; |
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developments relating to our competitors and our industry; |
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the impact of government laws and regulations; and |
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our expectations regarding the time during which we will be an emerging growth company under the JOBS Act. |