1072379--4/15/2008--NORTHWEST_BIOTHERAPEUTICS

related topics

{product, candidate, development}

{product, liability, claim}

{property, intellectual, protect}

{stock, price, share}

{personnel, key, retain}

{provision, law, control}

{cost, regulation, environmental}

{financial, litigation, operation}

{competitive, industry, competition}

{stock, price, operating}

We may not be able to retain existing personnel. We may not be able to attract expert personnel. We must rely at present on a single relationship with a third-party contract manufacturer, which will limit our ability to control the availability of our product candidates in the near-term. Our success partly depends on existing and future collaborators. We are involved in legal proceedings that could result in an adverse outcome, or that could otherwise harm our business. In addition, future litigation could be costly to defend or pursue and uncertain in its outcome. Clinical trials for our product candidates are expensive and time consuming and their outcome is uncertain. We have limited experience in conducting and managing clinical trials. Our product candidates will require a different distribution model than conventional therapeutic products. We lack sales and marketing experience and as a result may experience significant difficulties commercializing our research product candidates. Competition in the biotechnology and biopharmaceutical industry is intense and most of our competitors have substantially greater resources than us. Our intellectual property rights may not provide meaningful commercial protection for our research products or product candidates, which could enable third parties to use our technology, or very similar technology, and could reduce our ability to compete in the market. Our success will depend substantially on our ability to operate without infringing or misappropriating the proprietary rights of others. We may not receive regulatory approvals for our product candidates or there may be a delay in obtaining such approvals. Further trials and other costly and time-consuming assessments of the product may be required to obtain or maintain regulatory approval. Regulatory approval may be withdrawn at any time. We may fail to comply with regulatory requirements. We may be subject to sanctions if we are determined to be promoting our investigational products prior to regulatory approval or for unapproved uses. We may not obtain or maintain orphan drug status and the associated benefits, including marketing exclusivity. New legislation may have an adverse effect on our business. The availability and amount of reimbursement for our product candidates and the manner in which government and private payers may reimburse for our potential products is uncertain. DCVax is our only technology in clinical development. We may be prevented from using the DCVax name in Europe. Competing generic medicinal products may be approved. We may be exposed to potential product liability claims, and insurance against these claims may not be available to us at a reasonable rate in the future, if at all. We use hazardous materials and must comply with environmental, health and safety laws and regulations, which can be expensive and restrict how we do business. Toucan Capital and Toucan Partners beneficially own a majority of our shares of common stock and, as a result, the trading price for our common stock may be depressed and these stockholders can take actions that may be adverse to the interests of other investors. Our Certificate of Incorporation and Bylaws and stockholder rights plan may delay or prevent a change in our management. There may not be an active, liquid trading market for our common stock. The resale, or the availability for resale, of the shares placed in the PIPE Financing could have a material adverse impact on the market price of our common stock. Because our common stock is subject to penny stock rules, the market for the common stock may be limited. The price of our common stock may be highly volatile. Our business could be adversely affected by animal rights activists.

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1072379--4/15/2008--NORTHWEST_BIOTHERAPEUTICS_INC