2
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our status as a development‑stage company and our expectation to incur losses in the future; |
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our future capital needs and our need to raise additional funds; |
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our limited operating history; |
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the lengthy and expensive clinical development process with its uncertain outcome and potential for clinical failure or delay; |
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the decision by any applicable regulatory authority whether to clear our product candidates for clinical development and, ultimately, whether to approve them for marketing and sale; |
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our ability to anticipate and prevent adverse events caused by our product candidates; |
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our ability to identify, in‑license, acquire, discover or develop additional product candidates; |
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our ability to have our product candidates manufactured; |
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the market acceptance of our product candidates; |
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our ability to timely and successfully develop and commercialize our existing and future product candidates, if approved; |
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physician awareness and adoption of our product candidates; |
3
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the size of the market for our product candidates; |
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our ability to meet the quality expectations of physicians or patients; |
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our ability to improve our product candidates; |
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the decision of third‑party payors not to cover our product candidates or to require extensive or independently performed clinical trials prior to covering or maintaining coverage of our product candidates; |
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our ability to successfully manage our growth; |
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our ability to avoid product liability claims and maintain adequate product liability insurance; |
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our ability to obtain regulatory exclusivity; |
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our ability to obtain, maintain, protect and enforce our intellectual property rights related to our product candidates; |
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federal, state and foreign regulatory requirements applicable to our product candidates; and |
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ownership concentration of our executive officers and certain members of senior management may prevent our shareholders from influencing significant corporate decisions. |