Anymore............
Summary of Key Risks and Uncertainties The primary risks that may affect the Company during this fiscal year are summarized below. If any of the risks and uncertainties occurs, the business, financial condition, prospects, or results of operations for the Company could be materially adversely affected. The Company faces uncertainties related to regulatory approval which could result in delays in product commercialization in certain territories. Even if the Company obtains marketing approval, its products will be subject to ongoing regulatory review. The Company does not currently have a commercial infrastructure in the United States and may not be successful in building one in a timely fashion to coincide with future regulatory approvals. The Companys products, if approved, may fail to achieve market acceptance. The Company may not be able to manufacture its products in commercial quantities, which would prevent it from marketing its products. The Company does not yet have any commercial revenue and, as such, expects to continue to experience losses as a result of its ongoing operations. The Company relies on forecasts and estimates in its evaluation of the fair value of financial instruments and the recoverable amounts of assets in relation to impairment testing. The accuracy of such forecasts are inherently vulnerable to assumptions related to the timing of future events, the size of anticipated markets, the expected growth of sales, and forecasted costs of manufacturing facilities. If the Company cannot raise additional capital on acceptable terms, it may delay or be unable to pursue further development of its product portfolio, obtain regulatory approvals or commercialize its product candidates. The Company has certain long-term debt covenants which, if not met, could result in material contract breaches that would require the reclassification of the related debt to current liabilities. The Company does not currently have backup manufacturing capacity for its key product. The loss of a key supplier of certain raw materials could have a material adverse effect on the Companys business and financial condition. Rapid technological change could make the Companys products obsolete. Development of therapeutics is costly and require years of research and development. If the Company is unable to protect its intellectual property rights, its competitors may develop and market products with similar features that may reduce demand for its products and the effective commercialization of its products may be inhibited. The Company may become involved in lawsuits with respect to collaborations or protection or enforcement of its patents that would be expensive and time-consuming. The Company may not be able to successfully achieve its goals. The Company may incur losses associated with foreign currency fluctuations. The Company is subject to the risk of product liability claims, for which it may not have, nor be able to obtain, adequate insurance coverage. Some of the Companys products may use hazardous materials and, as a result, it is exposed to potential liability claims and to costs associated with complying with laws regulating hazardous waste. Future sales of Common Shares by the Company or its existing lenders or shareholders may cause its share price to fall. The Company has never paid dividends on its Common Shares.