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| related topics |
| {product, candidate, development} |
| {product, liability, claim} |
| {regulation, change, law} |
| {interest, director, officer} |
| {personnel, key, retain} |
| {control, financial, internal} |
| {stock, price, operating} |
| {competitive, industry, competition} |
|
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of our remaining assets to a third party and have materially reduced the scope of our current operations.
The Company is considering alternatives regarding future operations.
We have a history of losses and do not expect to achieve profitability.
We have received a going concern opinion from our independent registered public accounting firm, which may negatively impact our business.
We are subject to regulation by regulatory authorities including the FDA, which could delay or prevent marketing of our products. Unexpected regulatory outcomes could adversely affect our business and stock price.
Clinical trial results are very difficult to predict in advance, and the clinical trial process is subject to delays. Failure of one or more clinical trials or delays in trial completion could adversely affect our business and our stock price.
Adverse events in our clinical trials section may force us to stop development of our product candidates or prevent regulatory approval of our product candidates, which could materially harm our business.
Due to our reliance on contract research organizations or other third-parties to assist us in conducting clinical trials, we are unable to directly control all aspects of our clinical trials.
The type and scope of the patent coverage we have may limit the commercial success of our products.
We have limited sales and marketing experience.
If medical doctors do not prescribe our products or the medical profession does not accept our products, our product sales and business would be adversely affected.
We have very limited staffing and will continue to be dependent upon key personnel.
Our corporate compliance programs cannot guarantee that we are in compliance with all potentially applicable regulations.
Risks Relating to Our Industry
We are subject to the risk of clinical trial and product liability lawsuits.
Our stock price could be volatile
Full 10-K form ▸
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