Metabasis Therapeutics (MBRX)

Delays in the commencement or completion of clinical testing could result in increased costs to us and delay our ability to generate significant revenues.

        Delays in the commencement or completion of clinical testing could significantly impact our product development costs. We do not know whether planned clinical trials will begin on time or be completed on schedule, if at all. The commencement of clinical trials can be delayed for a variety of reasons, including delays in:

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obtaining regulatory approval to commence a clinical trial,



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reaching agreement on acceptable terms with prospective contract research organizations and trial sites,



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manufacturing sufficient quantities of a product candidate,



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obtaining institutional review board approval to conduct a clinical trial at a prospective site, and



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recruiting and enrolling patients to participate in a clinical trial.

        In addition, once a clinical trial has begun, it may be suspended or terminated by us, our collaborators, the FDA or other regulatory authorities due to a number of factors, including:

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failure to conduct the clinical trial in accordance with regulatory requirements or clinical protocols,



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inspection of the clinical trial operations or trial site by the FDA or other regulatory authorities resulting in the imposition of a clinical hold,



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unforeseen safety issues such as the serious adverse events recently observed in a clinical trial of CS-917, or



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lack of adequate funding to continue the clinical trial.

        If we experience significant delays in the commencement or completion of clinical testing, our product development costs may increase, we may lose any competitive advantage associated with early market entry and our ability to generate significant revenues may be delayed. In addition, many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of a product candidate.

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