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related topics |
{product, candidate, development} |
{property, intellectual, protect} |
{stock, price, operating} |
{operation, international, foreign} |
{loan, real, estate} |
{debt, indebtedness, cash} |
{interest, director, officer} |
{product, liability, claim} |
{personnel, key, retain} |
{customer, product, revenue} |
{product, market, service} |
{cost, regulation, environmental} |
{competitive, industry, competition} |
{control, financial, internal} |
{acquisition, growth, future} |
{stock, price, share} |
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Risks Related to Our Business
We continue to sustain losses and our revenues are not sufficient to sustain our operations.
We may incur losses associated with foreign currency fluctuations.
We may need additional capital to fulfill our business strategies. We may also incur unforeseen costs. Failure to obtain such capital would adversely affect our business.
The loss of the services of key personnel would adversely affect our business.
We are dependent on business partners to conduct clinical trials of, obtain regulatory approvals for, and manufacture, market, and sell our controlled release products.
We face competition in our industry, and many of our competitors have substantially greater experience and resources than we do.
We are dependent upon sales outside the United States, which are subject to a number of risks.
We rely upon third-party manufacturers, which puts us at risk for supplier business interruptions.
We are subject to extensive government regulation including the requirement of approval before our products may be marketed. Even if we obtain marketing approval, our products will be subject to ongoing regulatory review.
We may not be able to expand or enhance our existing product lines with new products limiting our ability to grow.
The market may not be receptive to products incorporating our drug delivery technologies.
We are subject to environmental regulations and any failure to comply may result in substantial fines and sanctions.
Our limited cash resources restrict our ability to pay cash dividends.
Risks Related to Our Intellectual Property
If we are not able to adequately protect our intellectual property, we may not be able to compete effectively.
If we infringe on the rights of third parties, we may not be able to sell our products, and we may have to defend against litigation and pay damages.
We may not be successful in defending the lawsuit filed by Biovail Laboratories SLR against us and may have to reimburse certain legal expenses and damages awarded.
Our controlled release products that are generic versions of branded controlled release products that are covered by one or more patents may be subject to litigation, which could delay FDA approval and commercial launch of our products
Risks Related to Our Securities:
The price of our common stock could be subject to significant fluctuations.
We have a concentration of stock ownership and control, and a small number of stockholders have the ability to exert significant control in matters requiring stockholder vote and may have interests that conflict with yours.
Our common stock is a high risk investment.
We became public by means of a reverse merger, and as a result we are subject to the risks associated with the prior activities of the public company with which we merged. In addition, we may not be able to attract the attention of major brokerage firms or institutional buyers
Full 10-K form ▸
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