Risks and uncertainties, the occurrence of which could adversely affect our business, include the following:
•
We have a history of operating losses and we do not expect to become profitable in the near future.
•
Our technologies are in an early stage of development and are unproven.
•
Our business is substantially dependent on our ability to develop, launch and generate revenue from our pharmaceutical and diagnostic programs.
•
Our research and development activities, or that of our investees, may not result in commercially viable products.
•
The results of previous clinical trials may not be predictive of future results, and our current and planned clinical trials may not satisfy the requirements of the United States (“U.S.”) Food and Drug Administration (“FDA”) or other non-U.S. regulatory authorities.
•
We may require substantial additional funding, which may not be available to us on acceptable terms, or at all.
•
We may finance future cash needs primarily through public or private offerings, debt financings or strategic collaborations, which may dilute your stockholdings in the Company.
•
If our competitors develop and market products that are more effective, safer or less expensive than our future product candidates, our commercial opportunities will be negatively impacted.
•
The regulatory approval process is expensive, time consuming and uncertain and may prevent us or our collaboration partners from obtaining approvals for the commercialization of some or all of our product candidates.
•
Failure to recruit and enroll patients for clinical trials may cause the development of our product candidates to be delayed.
•
Even if we obtain regulatory approvals for our product candidates, the terms of approvals and ongoing regulation of our products may limit how we manufacture and market our product candidates, which could materially impair our ability to generate anticipated revenues.
•
We may not meet regulatory quality standards applicable to our manufacturing and quality processes.
•
Even if we receive regulatory approval to market our product candidates, the market may not be receptive to our products.
•
The loss of Phillip Frost, M.D., our Chairman and Chief Executive Officer, could have a material adverse effect on our business and product development.
•
If we fail to attract and retain key management and scientific personnel, we may be unable to successfully develop or commercialize our product candidates.
•
In the event that we successfully evolve from a company primarily involved in development to a company also involved in commercialization, we may encounter difficulties in managing our growth and expanding our operations successfully.
News 
Market Data 
Discover 
