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| related topics |
| {product, candidate, development} |
| {stock, price, share} |
| {regulation, government, change} |
| {customer, product, revenue} |
| {competitive, industry, competition} |
| {product, liability, claim} |
| {provision, law, control} |
| {interest, director, officer} |
| {personnel, key, retain} |
| {product, market, service} |
| {cost, operation, labor} |
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RISKS RELATED TO OUR BUSINESS
The dialysis provider market is highly concentrated in national and regional dialysis chains that account for the majority of our domestic revenue. Our business is substantially dependent on one of our customers that accounts for a substantial portion of our sales. The loss of this customer would have a material adverse affect on our results of operations and cash flow.
We operate in a very competitive market against substantially larger competitors with greater resources.
Our new drug product requires FDA approval and expensive clinical trials before it can be marketed.
Even if our new drug product is approved by the FDA, we may not be able to market it successfully.
We may not be successful in maintaining our gross profit margins.
We depend on government funding of healthcare.
Orders from our international distributors may not result in recurring revenue.
We depend on key personnel.
Our business is highly regulated.
We depend on contract research organizations and consultants to manage and conduct our clinical trials and if they fail to follow our protocol or meet FDA regulatory requirements our clinical trial data and results could be compromised causing us to delay our development plans or have to do more testing than planned.
Foreign approvals to market our new drug products may be difficult to obtain.
Health care reform could adversely affect our business.
We may not have sufficient products liability insurance.
Our Board of Directors is subject to potential deadlock.
RISKS RELATED TO OUR COMMON STOCK
Shares eligible for future sale may affect the market price of our common shares.
The market price of our securities may be volatile.
Voting control and anti-takeover provisions reduce the likelihood that you will receive a takeover premium.
Full 10-K form ▸
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