This strategy is focused on identifying misdiagnosed and undiagnosed patients. Topline data is expected from the trial in the fourth quarter of 2021. Metabolism refers to a network of life sustaining chemical reactions in the body. We are targeting Arginase 1 Deficiency with our lead product candidate, pegzilarginase. These patents will expire in 2029 in the absence of any patent term extension. A voucher may be awarded only for an approved rare pediatric disease product application. The reported data are posted in searchable form on a public website on an annual basis. Different pricing and reimbursement schemes exist in other countries. On November 10, 2020, oral arguments were heard in this case. It is unclear when a decision will be made. 25 ITEM 1A. RISK FACTORS Investing in our common stock involves a high degree of risk. We have not dosed any of our other product candidates in humans. As of December 31, 2020, we had an accumulated deficit of $276.0 million. We will need substantial additional funding. For example, the timing of our Phase 3 PEACE trial has been impacted by COVID-19. Any such shortages could cause us to delay or terminate our combination trials. We may not be successful in our efforts to identify additional product candidates. As a result, its ultimate impact, implementation, and meaning are subject to uncertainty. In addition, the United States has recently enacted patent reform legislation. In such an event, this circumstance could have a material adverse effect on our business. Any of our management team members may terminate their employment with us at any time. We do not maintain "key person" insurance for any of our executives or other employees. It is possible that we may have triggered an "ownership change" limitation.