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our anticipated timing of regulatory submissions; commencement and completion of preclinical studies and clinical trials, meetings with the FDA and other regulatory authorities; and product approvals for gemcabene or any other product candidates we may pursue in the future; |
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the outcome of our ongoing preclinical toxicology studies related to our partial clinical hold with respect to clinical trials of longer than six months in duration; |
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the outcome of our Phase 2 and Phase 3 clinical trials of gemcabene and our ability to replicate positive results from a completed clinical trial in a future clinical trial; |
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our expected clinical trial designs and regulatory pathways; |
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our expectation that the FDA will not require us to complete a cardiovascular outcomes trial prior to approval; |
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our expectations for the attributes of gemcabene or any other product candidate we may pursue in the future, including pharmaceutical properties, efficacy, safety, dosing regimens and cost, as compared to other lipid-lowering therapies; |
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our ability to design an efficient development plan; |
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our expectation that our existing capital resources will be sufficient to enable us to complete our planned late stage clinical trials and complete certain preclinical studies; |
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our plans to advance the late-stage clinical development of gemcabene across multiple target indications, pursue oral combination opportunities for gemcabene, maximize the global commercial value of gemcabene and leverage the expertise and experience of our management team to evaluate future in-license acquisition opportunities; |
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our estimates regarding industry trends and market potential for gemcabene; |
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if approved, our ability to maintain regulatory approval of gemcabene and respond and adhere to regulatory requirements; |
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our ability to identify, in-license or acquire, develop and, if approved, successfully commercialize best-in-class products, including gemcabene or any other product candidates we may pursue in the future; |
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our ability to enhance brand awareness among key thought leaders and physicians; |
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if approved, the rate and degree of market acceptance of gemcabene or any other product candidates we may pursue in the future; |
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if approved, our ability to compete with other companies that are, or may be, developing or selling products that may compete with gemcabene; |
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reimbursement policies, including any future changes to such policies or related government legislation and our ability to sell gemcabene, if approved; |
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regulatory and legal developments in the United States and in foreign countries; |
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our ability to obtain and maintain intellectual property protection for gemcabene or any other product candidates we may pursue in the future and not infringe upon the intellectual property of others; |
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our ability to fund our working capital requirements; |
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our estimates of our expenses, ongoing losses, future revenue, capital requirements and our needs for, or ability to, obtain additional financing; |
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the ability of any third parties with whom we collaborate for the development and commercialization of gemcabene to successfully perform their assigned functions; |
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our ability to retain and recruit key scientific and management personnel; |
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our financial performance; and |
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our expectations regarding the period during which we qualify as an emerging growth company under the JOBS Act. |