Post by
beyourself81 on Oct 30, 2017 2:54pm
Some worrying parts of report
Had anyone else read these parts of the report? Must be mandatory to disclose or something? INHERENT RISK FACTORS You should carefully consider the following risks and uncertainties in addition to other information in this MD&A in evaluating the Company and its business before making any investment decision in regard to the common shares of the Company. The Companys operating and financial condition could be harmed due to any of the following risks. These risks reflect the companys involvement in Scientific Research and drug development as well as production of medical marijuana. Scientific Research and drug development Competition The market for the Companys research and development is highly competitive. The Company competes with other research companies who are also examining potential drug development for treating and managing pain. Many of its competitors have greater financial and operational resources. These and other companies may have developed or could in the future develop new drugs and or technologies that compete with the Companys current research and development plans or even render its research obsolete. Competition in the Companys markets is primarily driven by: timing of drugs and technological introductions; ability to develop, maintain and protect proprietary products and technologies; and expertise of research and development team. Litigation to Protect Companys Intellectual Property The Companys future success and competitive position depends in part upon its ability to maintain its intellectual property portfolio. There can be no assurance that any patents will be issued on any existing or 22 TETRA BIO-PHARMA INC. MANAGEMENTS DISCUSSION & ANALYSIS For the nine months ended August 31, 2017 and up to October 25, 2017 future patent applications. Even if such patents are issued, there can be no assurance that any patents issued or licensed to the Company will not be challenged. The Companys ability to establish and maintain a competitive position may be achieved in part by prosecuting claims against others who it believes to be infringing its rights. In addition, enforcement of the Companys patents in foreign jurisdictions will depend on the legal procedures in those jurisdictions. Even if such claims are found to be invalid, the Companys involvement in intellectual property litigation could have a material adverse effect on its ability to distribute any products that are the subject of such litigation. In addition, the Companys involvement in intellectual property litigation could result in significant expense, which could materially adversely affect the use responsibilities, whether or not such litigation is resolved in the Companys favour. Clinical testing and Regulatory approval Since the Companys success is dependent on the successful completion of clinical trials, regulatory approval and introduction of its products and technology into the market, and since the Company has completed none of the tasks at this time, the Company does not know if it will be able to complete them. The actual timing of these events can vary dramatically due to factors such as delays or failures in the Companys clinical trials and the uncertainties inherent in the regulatory approval process. The Company might not be able to obtain the necessary results from its clinical trials or to gain regulatory approval necessary for licensing its products and technology. The Companys failure to achieve these objectives will mean that an investor will not be able to recoup their investment or to receive a profit on their investment. Intellectual Property The Companys success depends to a significant degree upon its ability to develop, maintain and protect proprietary products and technologies. The Company may file patent applications in the United States, Canada, Europe, and selectively in other foreign countries as part of its strategy to protect its proprietary products and technologies. However, patents provide only limited protection of the Companys intellectual property. The assertion of patent protection involves complex legal and factual determinations and is therefore uncertain and expensive. The Company cannot provide assurances that patents will be granted with respect to any of its pending patent applications, that the scope of any of its patents will be sufficiently broad to offer meaningful protection, or that it will develop additional proprietary technologies that are patentable. This could result in the Companys patent rights failing to create an effective competitive barrier. Losing a significant patent or failing to get a patent to issue from a pending patent application that the Company considers significant could have a material adverse effect on its business. The laws governing the scope of patent coverage in various countries continue to evolve. The laws of some foreign countries may not protect the Companys intellectual property rights to the same extent as the laws of Canada and the United States. The Company holds patents only in selected countries. Therefore, third parties may be able to replicate technologies covered by the Companys patents in countries in which it does not have patent protection. Legal Proceedings In the course of the Companys business, the Company may from time to time have access to confidential or proprietary information of third parties, and these parties could bring a claim against the Company asserting that it has misappropriated their technologies and had improperly incorporated such technologies into its products. Due to these factors, there remains a constant risk of intellectual property litigation affecting the Companys business. In the future, the Company may be made a party to litigation involving intellectual property matters and such actions, if determined adversely, could have a material adverse effect on the Company. Dependence upon Management Although the Company Issuer is expected to have experienced senior management and personnel, it will be substantially dependent upon the services of a few key personnel, particularly Dr. Guy Chamberland for the successful operation of its business. The loss of the services of any of these persons could have a material adverse effect on the business of the Company. The Company may not be able to attract and retain personnel on acceptable terms given the intense competition for such personnel among high technology enterprises, including biotechnology, and healthcare companies, universities and non-profit research institutions. If it loses any of these persons, or is unable to attract and retain qualified personnel, its business, financial condition and results of operations may be materially and adversely affected. Going Concern The ability of the Company to continue as a going concern is dependent on its ability to generate future profitable operations and to obtain additional debt or equity financing. There can be no assurance that the Companys operations will achieve profitability in the future or that the Company will be able to successfully obtain financing on commercially reasonable terms or at all. Substantial Capital Requirements and Liquidity Substantial additional funds for the Companys research and development programs will be required. No assurances can be given that the Company will be able to raise the additional funding that may be required for such activities. To meet such funding requirements, the Company may be required to undertake additional equity financing, which would be dilutive to shareholders. Debt financing, if available, may also involve restrictions on financing and operating activities. There is no assurance that additional financing will be available on terms acceptable to the Company or at all. If the Company is unable to obtain additional financing as needed, it may be required to reduce the scope of its operations, or even cease its operations. Reliance on Third Parties The Company is relying on a third party to assist it in conducting its clinical trials. If this third party does not successfully carry out their contractual duties or meet expected deadlines, the Company may not be able to obtain regulatory approval for or commercialize its products or technology. Unproven market The Company believes that there will be many different applications for its products and technologies and that the anticipated market for these products and technologies will continue to expand. However, no assurance can be given that these beliefs will be correct owing, in particular, to competition from existing products and technologies or new products and technologies. Change in Laws, Regulations and Guidelines Tetras proposed operations are subject to a variety of laws, regulations and guidelines relating to the manufacture, management, transportation, storage and disposal of medical marijuana but also including laws and regulations relating to health and safety, the conduct of operations and the protection of the environment. While the impact of such changes are uncertain and are highly dependent on which specific laws, regulations or guidelines are changed and on the outcome of any such court actions, it is not expected that any such changes would have an effect on Tetras proposed operations that is materially different than the effect on similar-sized companies in the same business as Tetra. Risks Inherent to a Single Supplier The Companys business involves acquiring medical cannabis for the manufacture of its clinical trial product PPP001. Currently, the Company has a single supplier for this product. As such, the business is subject to supply risks that could delay its clinical program with PPP001, and could have an impact on its submission to Health Canada for drug approval, thereby delaying commercialization and its eventual revenue generation. Difficult to Forecast Detailed sales forecasts are not generally obtainable from sources at this early stage of the medical marijuana industry in Canada. A failure in the demand for products to materialize as a result of competition, technological change or other factors could have a material adverse effect on the proposed business, results of operations and financial condition of Tetra. Dependence on Suppliers and Skilled Labour The ability of Tetra to compete and grow will be dependent on it having access, at a reasonable cost and in a timely manner, to skilled labour, equipment, parts and components. No assurances can be given that Tetra will be successful in maintaining its required supply of skilled labour, equipment, parts and components. It is also possible that the final costs of any major equipment that may be contemplated by Tetras capital expenditure program may be significantly greater than anticipated by management, and may be greater than funds available to Tetra, in which circumstance Tetra may curtail, or extend the timeframes for completing, its capital expenditure plans. This could have an adverse effect on the financial results of Tetra. Reliance on Key Inputs The proposed business is dependent on a number of key inputs and their related costs including raw materials and supplies related to growing operations, as well as electricity, water and other local utilities. Any significant interruption or negative change in the availability or economics of the supply chain for key inputs could materially impact the business, financial condition and operating results of Tetra. Any inability to secure required supplies and services or to do so on appropriate terms could have a materially adverse impact on the proposed business, financial condition and operating results of Tetra.