Our primary target markets are hospital acute care, gastroenterology and rheumatology. In January 2020, we initiated a full-scale launch of this ready-to-use product. The product was developed and registered by Astellas. It is the first DMD clinical study approved for FDA Orphan Product Development funding. The study results and a proposed clinical development plan were discussed with the FDA. A Phase II study has been initiated and and patient enrollment completed. We currently market seven FDA approved products for sale in the United States. Build an international contribution to our business. Manage our operations with financial discipline. During 2019 we entered into a new packaging arrangement for this product. The 445 Acetadote Patent is scheduled to expire in August 2025. NAC is accepted worldwide as the standard of care for acetaminophen overdose. These drugs are manufactured by numerous pharmaceutical companies. The major generic competitors are vancomycin, linezolid, and daptomycin. If the NDA is found to be incomplete, it will not be accepted. The following highlights certain provisions of the legislation that may affect us. These laws include anti-kickback statutes and false claims statutes. Risk Factor SummaryInvesting in our common stock involves a high degree of risk. We have a relatively small internal infrastructure. The pharmaceutical industry is intensely competitive. Expansion of the market for our products may be subject to certain limitations. Adoption of such legislation could further limit reimbursement for pharmaceuticals. There is uncertainty with respect to the timing and impact of any changes. We could be adversely affected if we or our products are subject to negative publicity. Virtually all aspects of our business activities are regulated by government agencies. These regulations became effective on April 1, 2016. Also, others could acquire or independently develop similar technology. We might not be able to obtain such a license on terms acceptable to us or at all. As a result, we may incur losses in future periods.
