Question: What are the plans to publish the data from the European Sepsis Trial and can you give an update on the dosing study and other studies? Are the results of the dosing study needed to sell CytoSorb?
Dr. Chan: Yes, the manuscript is being prepared after completing some additional data analysis and conducting a number of data review and planning meetings with our key Germany investigators. Because there are so many valued opinions contributing to this manuscript, it makes things more complicated, but in the end, I believe it will result in a stronger paper.
In terms of the dosing study, we are working to have some data to discuss sometime this year. The data from this study will be important to expand the knowledge base of how to best use the device, and will be useful when we design a future US pivotal study. We do not believe that the results from this study are needed either to launch CytoSorb® or have clinicians use the product. In fact, early adopter clinicians are willing to use CytoSorb® not only for sepsis, but for things we haven’t even run clinical trials in, like pancreatitis, solid organ transplant, and many other applications. The key is that we have demonstrated that it is safe and that it removes cytokines efficiently. It will always be the case that the more data we can generate, the better strength we will have in marketing CytoSorb®, and we will continue our research programs for this purpose and to evaluate more specific potential uses of the device. We will seek to do this through a combination of company-sponsored trials as well as anticipated investigator-initiated studies. There will always be some clinicians that want to see published data before trying a new product and it is a priority for us to see our data reviewed and published as soon as it can be, as this will assist the sales efforts of the team we are putting in place.
Question: Are you contemplating manufacturing in Europe or utilizing a contract manufacturer?
Dr. Chan: In terms of manufacturing, our ISO 13485 certified facility is sufficient for our anticipated near term demand. It is not necessary to incur the cost of establishing manufacturing capabilities in Europe or elsewhere at this time.
Question: There seems to be a lot of bashers on the stock message boards that post negative comments constantly, always trying to instill fear and doubt into shareholders who believe in the company. What can be done?
Dr. Chan: For any company, there will always be those who believe and those who doubt. Apple, Google, Facebook, Pfizer and Intuitive Surgical, for example, are no different. Unlike these companies, however, smaller microcap companies with predominantly retail investors are sometimes disproportionately influenced by these stock message boards as it is often a prime place to exchange information or opinions. As for “bashers”, one has to ask why are they so persistent, constantly posting to try influence opinion, twisting even good news into bad? After all, we are a relatively unknown medical device company trying to bring a potentially revolutionary product to the market to save lives. What is so distasteful about that? The motives of these “bashers” typically are rooted in some kind of financial motivation. They could be “paid” posters who get money for every negative post they make. They could be competitors or their shareholders trying to discredit their competitors. They could be “investors” who profit if the stock goes down. Or they could be investors who want to build a position cheaply and are trying to get other investors to sell to lower the stock price, in order to accumulate stock. In the end, we can’t really speak to what motivates any individual person. Our position is to not get distracted by our critics, while staying focused on executing on our business strategy and building tangible value for shareholders through our products and research programs.