1360214--3/26/2009--TRANSDEL_PHARMACEUTICALS

related topics

{product, candidate, development}

{product, liability, claim}

{stock, price, share}

{product, market, service}

{control, financial, internal}

{personnel, key, retain}

{property, intellectual, protect}

{regulation, government, change}

{stock, price, operating}

Timing and results of clinical trials to demonstrate the safety and efficacy of products as well as FDA approval of products are uncertain. If we fail to comply with continuing federal, state and foreign regulations, we could lose our approvals to market drugs and our business would be seriously harmed. Delays in the conduct or completion of our clinical and non-clinical trials or the analysis of the data from our clinical or non-clinical trials may result in delays in our planned filings for regulatory approvals, and may adversely affect our business. None of our pharmaceutical product candidates, other than Ketotransdel , have commenced clinical trials. Once approved, there is no guarantee that the market will accept our products, and regulatory requirements could limit the commercial usage of our products. We may be subject to product liability claims. If our patents are determined to be unenforceable, or if we are unable to obtain new patents based on current patent applications or for future inventions, we may not be able to prevent others from using our intellectual property. The use of our technologies could potentially conflict with the rights of others. We will be dependent on outside manufacturers in the event that we successfully develop our product candidates into commercial products; therefore, we will have limited control of the manufacturing process, access to raw materials, timing for delivery of finished products and costs. One manufacturer may constitute the sole source of one or more of our products. We are dependent on third parties to conduct clinical trials and non-clinical studies of our drug candidates and to provide services for certain core aspects of our business. Any interruption or failure by these third parties to meet their obligations pursuant to various agreements with us could have a material adverse effect on our business, results of operations and financial condition. Our cosmetic/cosmeceutical product development program may not be successful. We currently have no internal sales and marketing resources and may have to rely on third parties in the event that we successfully commercialize our product. If we are unable to retain our key personnel or attract additional professional staff, we may be unable to maintain or expand our business. Risks Relating to Our Industry If we are unable to compete with other companies that develop rival products to our products, then we may never gain market share or achieve profitability. We may not be able to keep up with the rapid technological change in the biotechnology and pharmaceutical industries, which could make our products obsolete and reduce our potential revenues. Our ability to generate revenues will be diminished if we fail to obtain acceptable prices or an adequate level of reimbursement from third-party payors. Changes in the healthcare industry that are beyond our control may be detrimental to our business. Risks Relating to the Common Stock We are subject to financial reporting and other requirements for which our accounting and other management systems and resources may not be adequately prepared. If we fail to maintain an effective system of internal control, we may not be able to report our financial results accurately or to prevent fraud. Any inability to report and file our financial results accurately and timely could harm our business and adversely impact the trading price of our common stock. Public company compliance may make it more difficult to attract and retain officers and directors. Our stock price may be volatile. We have not paid dividends in the past and do not expect to pay dividends in the future. Any return on investment may be limited to the value of our common stock. Our common stock may be deemed a penny stock , which would make it more difficult for our investors to sell their shares.

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1360214--3/26/2009--TRANSDEL_PHARMACEUTICALS_INC