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We generally contract with third parties for the disposal of these materials and wastes. If we or any of our clinical research organizations fail to comply with applicable GCPs, the clinical data generated in our clinical trials may be deemed unreliable and the FDA or comparable foreign regulatory authorities may require us to perform additional clinical trials before approving our marketing applications.
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Our of operations could be materially negatively affected by economic conditions generally, both in the United States and elsewhere around the world. We will have to be diligent to ensure that any such situation is resolved by independent parties.
Men who are taught to work on their own or with a team to complete a mission, to me id very impressive. All of our contract manufacturers must comply with strictly enforced federal, state arez foreign regulations, including cGMP requirements enforced by the FDA through its facilities inspection program, as well as controlled substance handling and security requirements, and we have little control over their compliance with these regulations.
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For instance. Our future arrangements with third party payors, distributors, retailers, marketers and customers may expose us to broadly applicable fraud mahbe abuse and other healthcare laws and regulations, including, without limitation, the federal Anti-Kickback Statute, the federal False Claims Act, and sfeking state or foreign laws which may constrain the business or financial arrangements and relationships through which we sell, market and distribute any product candidates for which we obtain marketing approval.
Additionally, as an emerging growth company, we have elected to delay the adoption of new or revised ing standards that have different effective dates for public and private companies until those standards apply to private companies. Such forward-looking statements include, but are not limited to, statements about our:. We may be unable to build a successful brand identity for a new trademark in a timely manner or at maube, which would limit our ability to commercialize our product candidates.
You love you wife like I can only dream of being loved one day. The patent position of biotechnology and pharmaceutical companies generally is highly uncertain, involves complex legal and factual questions and has in recent years been the subject mkre much litigation. These new laws may result in additional reductions in Medicare and other healthcare funding. For example, we will remain responsible for ensuring that each of our preclinical studies and clinical trials are conducted in accordance with the general investigational plan and protocols for the trial and for ensuring that our preclinical studies are conducted in accordance with good laboratory practice, or GLP, as appropriate.
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If we adopt an alternative brand name, we would lose the benefit of our existing trademark applications for such product candidate and may be required to expend ificant additional resources in an effort to identify a suitable product brand name that would qualify under applicable trademark laws, not infringe the existing rights of third parties and be acceptable to the FDA. Our competitors may be able to circumvent our owned or d patents seekinh developing similar or alternative technologies or products in a non-infringing manner.
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An effective pain relief program should be individualized for the particular patient, operation, and circumstances. The FDA typically conducts a review of proposed product brand names, including an evaluation of potential for confusion with other product names.
Market acceptance could be further limited depending on the prevalence and severity of any expected or unexpected adverse side effects associated with our product candidates. We will obtain limited product liability insurance coverage for our upcoming clinical trials. Even though the postoperative pain market is entrenched with low cost, generic pain relievers, we believe that there still remains a ificant unmet medical need for safer and better-tolerated painkillers, which are also referred to as analgesics.
If the FDA requires us to conduct additional preclinical studies or clinical trials prior to approving IV Tramadol, our ability to obtain approval of this product candidate will be delayed. Moreover, the FDA requires us to comply with standards, commonly referred to as good clinical practices, or GCPs, for conducting, recording and reporting the of clinical trials to assure that data and reported are credible and accurate and that the rights, integrity and confidentiality of trial participants are protected.
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In addition, we seeikng incur substantial costs in order to comply with current or future environmental, health and safety laws and regulations. Neither we, nor any of our officers, directors, agents or representatives or underwriters, make any representation to you about the legality of an investment in our common stock. We might have received better terms from third parties because, among other things, third parties might have competed with each other to win our business.
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Some neq our competitors may be able to sustain the costs of such litigation or proceedings more effectively than we can because of their greater financial resources. We have not received approval to market IV Tramadol from regulatory authorities in any jurisdiction.
Seeeking sick of all the perves and creepers. On occasion, large judgments have been awarded in class action lawsuits based on drugs that had unanticipated side effects.
Our ability to become profitable depends upon our ability to generate revenue. Copies to:.
Our failure to comply with these laws and regulations also may result in substantial fines, penalties or other sanctions. Termination of these agreements or reduction or elimination of our rights under these agreements may result in our having to negotiate new or reinstated agreements with less favorable terms, or cause us to lose our rights under these agreements, including our rights to important intellectual property or technology.
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This risk is especially relevant for us because biotechnology and biopharmaceutical maye have experienced ificant stock price volatility in recent years. Patient enrollment is affected by other factors including, but not necessarily limited to:. Our failure to become and remain profitable would depress our value and could impair our ability to raise capital, expand our business, maintain our research and development efforts, diversify our product offerings or even continue our operations.
Any failure to comply with applicable regulations may result in fines and civil penalties, suspension of production, suspension or delay. However, the Leahy-Smith Act and its implementation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents, all of which sseking have a material adverse effect on our business and financial condition.
As a result, we are required to periodically perform an evaluation of our internal controls over financial reporting to allow management to report on the effectiveness of those controls, as required by Section of the Sarbanes-Oxley Act.
Understanding the range of available interventions and considering the type of surgery is essential to safe and effective pain management. For example, the loss of clinical trial data from completed clinical trials for IV Tramadol could result in delays in our regulatory approval efforts and ificantly increase our costs to recover or reproduce the data. We do not have any manufacturing facilities or personnel.
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We have incurred losses since our inception in February Because of the numerous risks and uncertainties associated with developing pharmaceutical products, we are unable to predict the timing or amount of increased expenses or zeeking or if, we will be able to achieve profitability. If the commercial manufacturers upon whom we rely to manufacture IV Tramadol, and any other product candidates we may in- fail to deliver the required commercial quantities on a timely basis at commercially reasonable prices, we would likely be unable to meet demand for our maybd and we would lose potential revenues.
Our competitors include pharmaceutical companies and biotechnology companies, as well as universities and public and private research institutions. If you invest in our common stock in this offering, your ownership interest will be diluted to the extent of the difference between the offering price per share of our common stock and the as adjusted net tangible book value per share of our common stock immediately after the offering.
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IV Tramadol and other future product candidates and the activities associated with their development and commercialization, including their de, testing, manufacture, safety, efficacy, recordkeeping, labeling, storage, approval, advertising, promotion, sale and distribution, are subject to comprehensive regulation by the FDA and other regulatory agencies in the United States and by the European Medicines Agency, or the EMA, and similar regulatory authorities outside the United States.
We intend to become a listed and traded public company.
Accordingly, our management will have broad discretion in the application of proceeds. Any such conflict of interest or pursuit by Fortress of a corporate opportunity independent of us could expose us to claims by our investors and creditors, and could harm our of operations. The process of obtaining marketing approvals, both in the United States and abroad, is expensive, may take many years if approval is granted at all, and can vary substantially based upon a variety of factors, including the type, complexity and novelty of the product candidates involved.
In addition, we may choose to raise additional capital due to market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating plans. Our business, financial condition or of operations could be harmed by any of these risks. I'm pretty independent, financially and otherwise. Dilution per share to new investors is determined by subtracting as adjusted net tangible book value per share after this offering from the offering price per share paid by new investors.
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