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related topics |
{product, candidate, development} |
{product, liability, claim} |
{customer, product, revenue} |
{acquisition, growth, future} |
{product, market, service} |
{personnel, key, retain} |
{stock, price, operating} |
{financial, litigation, operation} |
{property, intellectual, protect} |
{cost, regulation, environmental} |
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Certain Factors That May Affect Future Results
Our ability to successfully complete the development of, and obtain regulatory approval to market and sell, ferumoxytol as an IV iron replacement therapeutic is uncertain because the results of our clinical trials may not demonstrate that ferumoxytol is safe and efficacious.
We may not be able to obtain the necessary regulatory approvals in order to market and sell our products, and the approval process is lengthy and unpredictable.
We may not complete our development program, file the NDA for ferumoxytol and obtain regulatory approval for ferumoxytol as an IV iron replacement therapeutic in a timely or cost-effective manner.
We lack marketing and sales experience.
Our stock price has been and may continue to be volatile, and your investment in our stock could decline in value or fluctuate significantly.
We are dependent on a limited number of products and product candidates.
Our inability to obtain raw materials and our reliance on sole source suppliers could adversely impact our business.
We may not be successful in competing with other companies or our technology may become obsolete.
We are currently subject to litigation with one of our marketing partners, the unfavorable outcome of which might have a material adverse effect on our business.
We may need additional capital to achieve our business objectives.
Our operating results will likely fluctuate so you should not rely on a good or bad quarter to predict how we will perform over time.
We need to maintain, and possibly increase, our manufacturing capabilities in order to commercialize our products.
We have a limited number of customers and are dependent on our collaborative relationships.
We may be unable to address the issues raised by the FDA in the March 2005 approvable letter with respect to Combidex, and we may not be able to obtain FDA approval for Combidex.
Our success depends on our ability to attract and retain key employees.
We cannot be certain that our products will be accepted in the marketplace.
Our success is dependent on third-party reimbursement.
Our success depends on our ability to maintain the proprietary nature of our technology.
We are exposed to potential liability claims and we may not be able to maintain or obtain sufficient insurance coverage.
We are subject to environmental laws and potential exposure to environmental liabilities.
We may be unable to comply with continuing regulatory requirements even after our products have been approved for marketing.
Full 10-K form ▸
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