920947--8/14/2007--NORTHFIELD_LABORATORIES_INC

related topics

{product, candidate, development}

{property, intellectual, protect}

{product, liability, claim}

{cost, regulation, environmental}

{product, market, service}

{control, financial, internal}

{financial, litigation, operation}

{personnel, key, retain}

{acquisition, growth, future}

{regulation, change, law}

Our financial resources are limited and we will need to raise additional capital in the future to continue our business. We are developing a single product that is subject to a high level of technological risk. We are required to receive FDA approval before we may sell PolyHeme commercially, data from our clinical trials to date may not be adequate to obtain FDA approval, and we may be required to conduct additional clinical trials in the future. There may be limitations in the supply of the starting material for PolyHeme. The market may not accept our product. We rely on third parties to perform data collection and analysis with respect to our clinical trial and to assist in the preparation of our BLA for PolyHeme, which may result in costs and delays that prevent us from successfully commercializing our product. Our activities are and will continue to be subject to extensive government regulation. We currently manufacture PolyHeme at a single location and, if we were unable to utilize this facility, our ability to manufacture PolyHeme will be significantly affected, and we will be delayed or prevented from commercializing PolyHeme. Failure to increase manufacturing capacity may impair PolyHeme s market acceptance and prevent us from achieving profitability. There are significant competitors developing similar products. We do not have experience in the sale and marketing of medical products. Our profitability will be affected if we incur product liability claims in excess of our insurance coverage. We depend on the services of a limited number of key personnel. Our ability to generate revenue from our product will depend on reimbursement and drug pricing policies and regulations. Failure to obtain regulatory approval in foreign jurisdictions would prevent our product from being marketed abroad. Failure to maintain effective internal controls over financial reporting could have a material adverse effect on our business, operating results and stock price. We are subject to a variety of federal, state and local laws, rules and regulations related to the discharge or disposal of toxic, volatile or other hazardous chemicals. We are subject to a putative class action lawsuit and have received requests from both the SEC and the Senate Committee on Finance asking us voluntarily to provide information. RISKS RELATED TO OUR INTELLECTUAL PROPERTY Our success depends upon our ability to protect our intellectual property and our proprietary technology. We rely on trade secrets and other confidential information to maintain our proprietary position. We may be involved in lawsuits to protect or enforce our patents, which could be expensive and time consuming. Third parties may own or control patents or patent applications that are infringed by our product or technologies.

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920947--8/14/2007--NORTHFIELD_LABORATORIES_INC_/DE/