The FDA has set a PDUFA date of April 29, 2021. We have not generated any revenues from product sales. As of December 31, 2020, we had an accumulated deficit of $554.8 million. Any FDA enforcement action could have a material adverse effect on us. Additional preclinical testing may continue even after the IND is submitted. In January 2011, CMS implemented a new prospective payment system for dialysis treatment. We are Fearless, aware that by challenging convention, we truly innovate. Ensuring fair and equitable pay is integral to our commitment to our employees. Claims could also be asserted under state consumer protection acts. 19 Table of Contents●The COVID-19 pandemic continues to rapidly evolve. As a result, increasingly high barriers are being erected to the entry of new products. We are a clinical-stage biopharmaceutical company with a limited operating history. We do not currently carry biological or hazardous waste insurance coverage. Despite the time and expense exerted, failure can occur at any stage. We may be required to indemnify future collaboration partners against such claims.