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related topics |
{product, candidate, development} |
{product, liability, claim} |
{stock, price, share} |
{stock, price, operating} |
{personnel, key, retain} |
{acquisition, growth, future} |
{cost, regulation, environmental} |
{property, intellectual, protect} |
{regulation, change, law} |
{control, financial, internal} |
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The testing process for the Company s drug candidates is long, costly, and uncertain, and most drug candidates do not get approved. Even if approved for use in humans, the Company s drug candidates may later prove to be unsafe or ineffective
The Company is subject to strict governmental regulation. If the Company cannot obtain product approvals or if it cannot comply with ongoing governmental regulations, its business could be adversely affected.
The Company faces vigorous competition in the areas of drug discovery and development, which may result in others developing or commercializing products before or more successfully than it does.
The Company has limited experience in the clinical process and relies heavily on its collaborative partners for research and development funding and commercialization.
A consequence of entering into collaborative arrangements is that the Company s potential upside is smaller if a successful product emerges than if it successfully commercialized a product on its own.
The Company periodically explores new alliances that may never materialize or may fail.
Developing the Company s drug candidates, particularly its unpartnered product candidates, will require significant additional expenditures. The Company is not certain how much capital it may need, and it may have difficulty raising needed capital in the future on favorable terms or at all.
The Company s patents, trade secrets and confidentiality agreements with collaborators, employees and others may be invalidated or inadequate to protect its intellectual property.
The Company is subject to uncertainties regarding healthcare reimbursement and reform. In the event that it is successful in bringing any products to market, its revenues may be adversely affected if it fails to obtain acceptable prices or adequate reimbursement for the cost of its products from third-party payors.
The Company may be unable to attract and retain qualified management and technical personnel.
relies upon third parties for its manufacturing requirements, and it cannot assure the reader that it will be able to manufacture products on a timely and competitive basis.
lacks marketing and sales experience.
The Company s business exposes it to clinical trial and product liability claims.
The Company s business involves hazardous materials and the risk of environmental liability.
The price of the Company s common stock may be volatile.
The Company s existing stockholders have significant control of its management and affairs.
If the Company s stockholders sell substantial amounts of its common stock, the market price of its common stock may fall.
The Company does not expect to pay dividends on its common stock.
The Company anticipates future losses and may never become profitable.
Accounting pronouncements may affect the Company s future financial position and results of operations.
Full 10-K form ▸
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