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          Clinical testing is very expensive and can take many years. Results attained in early human clinical trials may not be indicative of

results in later clinical trials. 臨床測試的費用是非常昂貴的，并要進行許多年。在早期的人體臨床試驗獲得的結果可能未必能反映 In addition, many of our investigational or experimental drugs are at an early stage of development, and successfulcommercialization of early stage product candidates requires significant research, development, testing and approvals by regulators, andadditional investment. 此外，我們在早期的發展階段的研究或實驗性藥物，并成功的成為商業中的早期階段的候選產品，需要顯著的研究，開發，測試及監管機構的批準，才能獲得投資。
Our products in the research or pre-clinical development stage may not yield results that would permit or justify clinicaltesting. Our failure to demonstrate adequately the safety and efficacy of a product under development would delay or prevent marketingapproval, which could adversely affect our operating results and credibility.

 

Setbacks in clinical development programs could adversely affect us.挫折的臨床開發項目造成不利影響。

 

          We and our collaborators continue to conduct clinical trials, including trials of RELISTOR and other drug candidates. If the results of

these or future trials are not satisfactory, we or our collaborators encounter problems enrolling subjects, clinical trial supply issues or otherdifficulties arise, or we or our collaborators experience setbacks in developing drug formulations, including raw material-supply,

manufacturing or stability difficulties, the entire development program for that product or candidate could be adversely affected, resulting indelays in trials or regulatory filings for further marketing approval. Conducting additional clinical trials or making significant revisions to theclinical development plan would lead to delays in regulatory filings. If clinical trials indicate a serious problem with the safety or efficacy of aproduct or candidate, we or our collaborators may stop development or commercialization of affected products. Since RELISTOR is our onlyapproved product, any setback of these types with respect to it could have a material adverse effect on our business, results of operations andfinancial condition.

 

         Ono is conducting required clinical trials with Japanese patients to obtain regulatory approval of RELISTOR in Japan. There can be

no assurance that these clinical trials will yield results adequate for that regulatory approval.

 

          If the results of current or future clinical studies of our product candidates are not satisfactory, we would need to reconfigure our

clinical trial programs to conduct additional trials or abandon the program involved.如果目前或未來的候選產品的臨床研究結果并不理想，我們需要重新配置我們的臨床試驗計劃，以便進行更多的試驗，或放棄參與該計劃。

 

Clinical trials often take longer than expected.臨床試驗時間往往需要比預期更長。

 

          Projections that we publicly announce of commencement and duration of clinical trials may not be certain. For example, we have

experienced clinical trial delays in the past as a result of slower than anticipated enrollment. These delays may recur. Delays can be caused by,among other things, deaths or other adverse medical events; regulatory or patent issues; interim or final results of ongoing clinical trials; failureto enroll clinical sites as expected; competition for enrollment from clinical trials; scheduling conflicts with participating clinicians andinstitutions; disagreements, disputes or other matters arising from collaborations; our inability to obtain necessary funding; or manufacturingproblems.

 

          We have limited experience in conducting clinical trials, and we rely on others to conduct, supervise or monitor some or all aspects ofsome of our clinical trials. In addition, certain clinical trials for our product candidates may be conducted by government-sponsored agencies,and consequently will be dependent on governmental participation and funding. Under our License Agreement with Salix, Salix generally hasresponsibility for conducting RELISTOR clinical trials, including all trials outside of the United States other than Japan, where Ono has theresponsibility for clinical trials. We have less control over the timing and other aspects of these clinical trials than if we conducted them entirely on our own.http://www.ttc-switch.com/dissertation_writing/Ecommerce/

 

Our product candidates may not obtain regulatory approvals needed for marketing.我們的產品候選人可能無法獲得所需的市場營銷監管部門的批準。

 

         None of our product candidates other than RELISTOR has been approved by applicable regulatory authorities for marketing. The

process of obtaining FDA and foreign regulatory approvals often takes many years and can vary substantially based upon the type, complexityand novelty of the products involved. We have had only limited experience in filing and pursuing applications and other submissions necessaryto gain marketing approvals. Products under development may never obtain marketing approval from the FDA or other regulatory authoritiesnecessary for commercialization.

 

 Even if our products obtain marketing approval, they may not be accepted in the marketplace.

即使我們的產品得到市場認可，他們可能也不被市場接受的。

          The commercial success of our products will depend upon their acceptance by the medical community and third party payors as

clinically useful, cost effective and safe. If health care providers believe that patients can be managed adequately with alternative, currently available therapies, they may not prescribe our products, especially if the alternative therapies are viewed as more effective, as having a bette rsafety or tolerability profile, as being more convenient to the patient or health care providers or as being less expensive. For pharmaceuticals administered in an institutional setting, the ability of the institution to be adequately reimbursed could also play a significant role in demand for our products. Even if our products obtain marketing approval, they may not achieve market acceptance. If any of our products do not achieve market acceptance, we will likely lose our entire investment in that product.
即使我們的產品得到市場認可，他們可能也無法完全獲得市場接受。如果我們的產品沒有達到市場的認可，我們很可能會失去我們該產品全部投資。