对于销售产品出现健康风险的危害分析

Table of Contents目录

 

 

 

     Efficacy or safety concerns regarding a marketed product, or manufacturing or other problems, may lead to a recall,  withdrawal of marketing approval, reformulation of the product, additional pre-clinical testing or clinical trials, changes in labeling,the need for additional marketing applications, declining sales or other adverse events.
关于销售的产品，或生产中的其他问题或安全问题，可能会导致召回，已经销售许可权被撤销，新的产品需要进行额外的预临床试验或临床试验，改变标签的行为需要额外的营销，拒绝销售或其他不良事件的发生。
These potential consequences may occur whether or not the concerns originate from subsequent testing or other activities by us, governmental regulators, other entities or  organizations or otherwise, and whether or not they are scientifically justified. If products lose previously received marketing and other approvals, our financial results would be adversely affected.

 

    We or our collaborators will be subject to ongoing FDA obligations and continuous regulatory review, and might be required to undertake post-marketing trials to verify the product’s efficacy or safety or other regulatory obligations.Competing products in development may adversely affect acceptance of our products.

 

        We are aware of a number of products and product candidates described in this Annual Report under Business – Competition which compete or may potentially compete with RELISTOR. Any of these approved products or product candidates, or others which may be developed http://www.ukthesis.org/gjswglzy/ in the future may achieve a significant competitive advantage relative to RELISTOR, and, in any event, the existing or future

marketing and sales capabilities of these competitors may impair Salix’s and/or Ono’s ability to compete effectively in the market.

 

        We are also aware of competitors which are developing alternative treatments for disease targets to which our research and

development programs are directed, any of which – or others which may be developed in the future – may achieve a significant competitive advantage relative to any product we may develop.

 

  Developing product candidates may require us to obtain additional financing. Our access to capital funding is uncertain.
开发的候选产品，我们可能需要取得额外融资。我们获得资金的数量，是不确定的。

 

    We expect to continue to incur significant development expenditures for our product candidates, and do not have committed external

sources of funding for most of these projects. These expenditures will be funded from cash on hand, or we may seek additional external

funding for them, most likely through collaborative, license or royalty financing agreements with one or more pharmaceutical companies,

securities issuances or government grants or contracts. We cannot predict when we will need additional funds, how much we will need, the form any financing may take (such as securities issuance or royalty or other financing), or whether additional funds will be available at all,especially in light of current conditions in global credit and financial markets. Our need for future funding will depend on numerous factors,such as the availability of new product development projects or other opportunities which we cannot predict, and many of which are outsideour control. We cannot assure you that any currently-contemplated or future initiatives for funding our product candidate programs will besuccessful.

 

          Our access to capital funding is always uncertain. Stresses in international markets are still affecting access to capital. We may not be able at the necessary time to obtain additional funding on acceptable terms, or at all. Our inability to raise additional capital on terms

reasonably acceptable to us would seriously jeopardize our business.

 

         If we raise funds by issuing and selling securities, it may be on terms that are not favorable to existing stockholders. If we raise fundsby selling equity securities, current stockholders will be diluted, and new investors could have rightssuperiortoexistingstockholders. Raisingfunds by selling debt securities often entails significant restrictive covenants and repayment obligations.

 

 If we are unable to negotiate collaborative agreements, our cash burn rate could increase and our rate of product development could

decrease.如果我们无法协商达成合作协议，我们的现金消耗率可能会增加，我们的产品开发速度减少。

 

         We may not be successful in negotiating additional collaborative arrangements with pharmaceutical and biotechnology companies todevelop and commercialize product candidates and technologies. If we do not enter into new collaborative arrangements, we would have todevote more of our resources to clinical product development and product-launch activities, seeking additional sources of capital, and our cashburn rate would increase or we would need to take steps to reduce our rate of product development.

 

  If testing does not yield successful results, our products will not be approved.

如果测试产生不成功的结果，我们的产品将不会被批准。

         Regulatory approvals are necessary before product candidates can be marketed. To obtain them, we or our collaborators must

demonstrate a product’s safety and efficacy through extensive pre-clinical and clinical testing. During this process, we may find that, for

example, results of pre-clinical studies are inconclusive or not indicative of results in human clinical trials, or that potential products do nothave the desired efficacy or have undesirable side effects or other characteristics that preclude marketing approval or limit their potentialcommercial use if approved.
   We, our collaborators or regulators may also suspend or terminate clinical trials if we or they believe that theparticipating subjects are being exposed to unacceptable health risks, or after reviewing test results, we or our collaborators may abandon projects which we previously believed to be promising.
我们的合作者或监管机构也可能暂停或终止临床试验，如果我们或他们认为暴露不可接受的健康风险，或复审测试结果后，我们或我们的合作者可能会放弃我们以前认为是有前途的项目。