“While the total exposure to these impurities for most patients was small, we are deeply concerned that patients were exposed to this impurity in the first place and that the presence of nitrosamines went undetected for a period of time. The potential for the development of genotoxic impurities during manufacturing processes is an area of intense focus. We’ll continue to improve our science and standards for detecting and preventing these risks,” the agency stated.

Yang, J. et al. Smad-dependent and smad-independent induction of id1 by prostacyclin analogues inhibits proliferation of pulmonary artery smooth muscle cells in vitro and in vivo. Circ. Res. 107, 252–262 (2010).

As a toxicologist, I’ll note that N-nitrosodiethylamine is a carcinogen to be concerned about. Now, agencies like EPA and IARC label virtually anything as carcinogenic, it can be hard to decide what to be concerned about. Most nitrosamines are very dangerous.

        Any of these events could harm our business and operations and could negatively impact our stock price.

        We qualify as an "emerging growth company" as defined in the Jumpstart Our Business Startups Act of 2012, as amended, or the JOBS Act. As an emerging growth company, we may take advantage

Market data and certain industry data and forecasts used throughout this annual report were obtained from internal company surveys, market research, consultant surveys commissioned by the Company, publicly available information, reports of governmental agencies and industry publications and surveys. Industry surveys, publications, consultant surveys commissioned by the Company and forecasts generally state that the information contained therein has been obtained from sources believed to be reliable. However, this information may prove to be inaccurate because of the method by which some of the data for the estimates is obtained or because this information cannot always be verified with complete certainty due to the limits on the availability and reliability of raw data, the voluntary nature of the data gathering process and other limitations and uncertainties. As a result, the market and industry data and forecasts included or incorporated by reference in this annual report, and estimates and beliefs based on that data, may not be reliable. We have relied on certain data from third-party sources, including internal surveys, industry forecasts and market research, which we believe to be reliable based on our management’s knowledge of the industry. However, we have not ascertained the underlying economic assumptions relied upon therein. Forecasts are particularly likely to be inaccurate, especially over long periods of time. In addition, we do not necessarily know what assumptions regarding general economic growth were used in preparing the forecasts we cite. Statements as to our market position are based to the best of our knowledge on the most currently available data. While we are not aware of any misstatements regarding the industry data presented in this annual report, our estimates involve risks and uncertainties and are subject to change based on various factors, including those discussed under the heading “Risk Factors” in this annual report.

In addition, we rely and intend to rely on third-parties, including our clinical research organizations, third-party manufacturers and second source suppliers, and certain other important vendors and consultants. As a result of volatile and unpredictable global economic situations, there may be a disruption or delay in the performance of our third-party contractors and suppliers. If such third-parties are unable to satisfy their contractual commitments to us, our business could be severely adversely affected.

Y.Y.C. performed the research, analyzed the data and wrote the manuscript; Q.L., C.S.P., L.Y., C.S.W. and J.Y.H. designed the research; Y.B. contributed to echocardiographic analysis; A.P.L. and B.H. contributed to proteomic and network analysis; K.H., K.S., Q.F.C. and Y.Y.L. contributed to the others experiments. J.Y.F. and J.Y.H. revised the manuscript. All authors have read and agreed with the manuscript.

We have never declared or paid any cash dividends on our ordinary shares and do not anticipate paying any cash dividends in the foreseeable future. Payment of cash dividends, if any, in the future will be at the discretion of our Board and will depend on then-existing conditions, including our financial condition, operating results, contractual restrictions, capital requirements, business prospects and other factors our Board may deem relevant.

In response to the valsartan recall, André’s company is now conducting audits that zero in on the potential for any process to generate genotoxic impurities. So far, audits have found three problematic synthetic drug substances, says André. One of them is levocarnitine, synthesized from a probable carcinogen, epichlorohydrin. Depending on how it is synthesized, the compound may not only contain epichlorohydrin, but also traces of cyanide.

For cash bonuses granted to Mr. Baharaff see “Item 6. Directors, Senior Management and Employees— B. Compensation—Individual Compensation of Covered Executives.” For outstanding equity-based awards granted to Mr. Baharaff see below under “Item 6. Directors, Senior Management and Employees—E. Share Ownership—Certain Information Concerning Equity Awards to Office Holders.”

I am not always sure where to put the limit. So let’s have fun as long as it is clear from the context that we are just speculating.