In August 2016, our first commercial product, SUSTOL, was approved by the FDA. In November 2017, our second commercial product, CINVANTI was approved by the FDA. An NDA for HTX-019 is planned in late 2021 for prevention of PONV in adults. HTX-011 (ZYNRELEF in Europe) is an investigational agent in the U.S. and Canada. CINVANTI faces significant competition. Moreover, recent health care reform legislation has strengthened many of these laws. Failure to submit required information can result in civil monetary penalties. Therefore, these privacy and security requirements do not apply to us. Developing and maintaining a positive corporate culture is a priority for Heron. 22 Risk Factor Summary Investing in our securities involves a high degree of risk. Importantly, this summary does not address all of the risks that we face. 8226; We may not obtain regulatory approval for our Product Candidates in development. It is unclear whether or how the Biden administration will move forward with the Rule. Regulatory approval may also be delayed, limited or prevented by other factors. Further, we may not be successful in overseeing any such collaborative arrangements. We rely on independent third parties to provide certain services to us. 44 The outcome of clinical testing is inherently uncertain. The FDA and other regulatory agencies do not regulate a physician's choice of treatments. Patents, if issued, may be challenged, invalidated or circumvented. In addition, the limited trading volume of our stock may contribute to its volatility.