356591--3/25/2009--NEUROLOGIX_INC/DE

related topics
{product, candidate, development}
{product, liability, claim}
{property, intellectual, protect}
{cost, regulation, environmental}
{personnel, key, retain}
{regulation, government, change}
The Company Has Not Demonstrated that it Can Establish Many Necessary Business Functions. If the Clinical Trials for Parkinson s Disease are Unsuccessful, it Would Likely Have a Material Adverse Effect on the Company s Operations. The Company Cannot Ensure that it will be Able to Pursue Further Trials for its Product Candidates or the Timing of any Future Trials. The Company s Future Success Depends Upon Key Physicians and Researchers. The Company is Subject to Stringent Regulation; FDA Approvals. The Company s Research Activities are Subject to Review by the RAC. The Company May Face Substantial Penalties if it Fails to Comply with Regulatory Requirements. The Company Will Need to Conduct Significant Additional Research and Testing Before Conducting Clinical Trials Involving Future Product Candidates. The Company s Future Success Depends Upon Acceptance of its Products by Health Care Administrators and Providers. Events in the General Field of Gene Transfer May Affect the Company s Ability to Develop its Products. Side Effects, Patient Discomfort, Defects or Unfavorable Publicity May Affect the Company s Ability to Commercialize its Products. The Company Does Not Have any Experience in Manufacturing Products for Commercial Sale. The Company s Ability to Manufacture Products Depends upon FDA Approval and Access to Third-Party Manufacturing Facilities. If the Company Fails to Meet Certain Milestones Related to its Intellectual Property Licenses with Third Parties, the Company Could Forfeit License Rights That Are Important to its Business. The Company s Intellectual Property Rights May Be Called into Question or Subject to Litigation. The Company May be Subject to Product Liability Claims in Connection with its Clinical and Pre-Clinical Trials. The Company May Face Liability Due to its Use of Hazardous Materials.

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