Our registered office is located at One New Change, London EC4M 9AF, England. We expect to receive a decision from the NMPA in Mainland China near the end of 2021. The review process in Hong Kong is expected to conclude near the end of 2021. On November 4, 2020, our rehearing and en banc petitions were denied. In April 2011, we reported topline results from the ANCHOR trial. There were no treatment-related serious adverse events in this study. As such, the resulting conclusions from such sources should be viewed with caution. VASCEPA is under registration in additional countries in the MENA region. Multiple generic versions of Lovaza are available in the United States. Both studies were conducted to support a planned 505(b)(2) registration pathway. In August 2020, Afimmune reported Ph2a study results of epeleuton in patients with NAFLD. Most regulatory regimes outside the United States are similar in this regard. In contrast, mean LDL-C levels have decreased. The data are generated in two distinct development stages: preclinical and clinical. The lawsuit, captioned Amarin Pharma, Inc., et al. A trade deal was entered into between the UK and the EU on December 24, 2020. Unlike Medicare Part A and B, Part D coverage is not standardized. It is impossible to determine whether similar taxes could be instated in the future. The rebates are calculated as the difference between the annual Non-FAMP and FCP. We are the owner of the above-listed patents. In November 2020, Hikma launched its generic version of VASCEPA on a limited scale. We seek ways to continually improve in this area. We 33 have not had any mass layoffs of employees. 8226; Our promotion of VASCEPA is subject to regulatory scrutiny and associated risk. A secondary goal for this patient population is to reduce cardiovascular risk. Our promotion of VASCEPA is subject to regulatory scrutiny and associated risk generally. We are cooperating with the DOJ. Results are expected in fourth quarter of 2021. In addition, COVID-19 has limited the ability of suppliers to be inspected. In January 2020, HLS obtained an extended regulatory exclusivity designation. We plan to vigorously defend our rights under issued patents. We may require substantial additional resources to fund our operations. There can be no assurance that we will not be considered a PFIC for any taxable year.