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related topics |
{product, candidate, development} |
{stock, price, share} |
{property, intellectual, protect} |
{personnel, key, retain} |
{product, market, service} |
{control, financial, internal} |
{provision, law, control} |
{acquisition, growth, future} |
{financial, litigation, operation} |
{product, liability, claim} |
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Failure to obtain and maintain required regulatory approvals would severely limit our ability to sell our products.
Any changes in the governmental regulatory classifications of our products could prevent, limit or delay our ability to market or develop our products.
Our inability to complete our product development activities successfully would severely limit our ability to operate or finance operations.
We must successfully complete our clinical trials to be able to market certain of our products.
Failure of third parties to manufacture component parts or provide limited source supplies, or imposition of additional regulation, would impair our new product development and our sales activities.
Manufacturing our cell products in centralized facilities may increase the risk that we will not have adequate quantities of our cell products for clinical programs.
Even if we obtain regulatory approvals to sell our products, lack of commercial acceptance could impair our business.
The market for our products will be heavily dependent on third party reimbursement policies.
Use of animal-derived materials could harm our product development and commercialization efforts.
Given our limited internal manufacturing, sales, marketing and distribution capabilities, we need to develop increased internal capability or collaborative relationships to manufacture, sell, market and distribute our products.
The issuance of additional common stock for funding has the potential for substantial dilution.
Our stock price has been volatile and future sales of substantial numbers of our shares could have an adverse affect on the market price of our shares.
Our stock may be delisted from Nasdaq, which could affect its market price and liquidity.
If we do not keep pace with our competitors and with technological and market changes, our products will become obsolete and our business may suffer.
We have experienced significant management turnover, and if we cannot attract and retain key personnel, then our business will suffer.
If our patents and proprietary rights do not provide substantial protection, then our business and competitive position will suffer.
Intellectual property litigation could harm our business.
The government maintains certain rights in technology that we develop using government grant money and we may lose the revenues from such technology if we do not commercialize and utilize the technology pursuant to established government guidelines.
Potential product liability claims could affect our earnings and financial condition.
Our corporate documents and Michigan law contain provisions that may make it more difficult for us to be acquired.
We are required to evaluate our internal control over financial reporting under Section 404 of the Sarbanes-Oxley Act of 2002 and any adverse results from such evaluation could have a negative market reaction.
Full 10-K form ▸
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