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related topics |
{stock, price, share} |
{product, liability, claim} |
{acquisition, growth, future} |
{competitive, industry, competition} |
{personnel, key, retain} |
{interest, director, officer} |
{product, candidate, development} |
{cost, regulation, environmental} |
{product, market, service} |
{provision, law, control} |
{regulation, change, law} |
{control, financial, internal} |
{property, intellectual, protect} |
{customer, product, revenue} |
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Risks Related To Our Business
We will require additional capital, and if additional capital is not available, we may have to curtail or cease operations.
We have not been profitable and expect future losses.
Our independent registered public accounting firm has expressed substantial doubt about our ability to continue as a going concern.
Many of the products manufactured by us contain controlled substances, the supply of which is regulated.
We are dependent on a small number of suppliers for our raw materials and any delay or unavailability of raw materials can materially adversely affect our ability to produce products.
Our failure to prevail in our pending litigation against Dr. Mulye and Nostrum would result in dilution of existing shareholders and further disagreements between management and Dr. Mulye and Nostrum.
We have a relatively limited operating history, which makes it difficult to evaluate our future prospects and are implementing a new business model, an off-shore Front End growth strategy.
A failure to locate and hire a suitable permanent Chief Executive Officer could have a material adverse effect on our operations and financial results.
Our failure to compete effectively may limit our ability to achieve profitability.
We may fail to establish or cultivate strategic partnerships to expand our business.
We may become subject to increased governmental regulation, which could increase the costs or cause us to revise certain product claims.
We can provide no assurance of the successful and timely development of our new products.
We face product liability risks and may not be able to obtain adequate insurance to protect us against losses.
If key personnel were to leave us or if we are unsuccessful in attracting qualified personnel, our ability to develop products could be materially harmed.
We rely on trade secrets, unpatented proprietary expertise and continuing innovation to protect our proprietary interests.
Risks Related to Our Industry
The biotechnology and biopharmaceutical industries are characterized by rapid technological developments and a high degree of competition. We may be unable to compete with more substantial enterprises.
The industry in which we operate is highly competitive.
The government regulatory approval process is time consuming and expensive.
Any manufacturer producing our products will be required to comply with extensive government regulation.
The commercial success of any newly-introduced pharmaceutical product depends in part upon the ability of patients to obtain adequate reimbursement.
Risks Related To Our Common Stock
The securities markets have recently been highly volatile.
Our common stock is thinly traded and may experience price volatility, which could affect a stockholder s ability to sell our stock or the price for which it can be sold.
Rights to acquire shares of our common stock may have a negative effect on the trading prices of our common stock as well as a dilutive effect.
If penny stock regulations become applicable to our common stock they will impose restrictions on the marketability of our common stock and the ability of our stockholders to sell shares of our stock could be impaired.
It may be difficult for a third party to gain control of us, even if the acquisition of control would be in the best interests of our stockholders.
Our by-laws have been amended to restrict the ability of stockholders to participate in the election of directors and the presentation of matters at stockholder meetings.
We will have insufficient authorized capital to issue common stock to all of our holders of warrants and other convertible securities.
Full 10-K form ▸
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