With this approach, we are targeting submitting this BLA in 2024. Each protocol must be submitted to the FDA as part of the IND. The entry into application of the Clinical Trials Regulation has been delayed. Regenerative medicine advanced therapy ("RMAT") designation. Violation of these laws could result in substantial fines and imprisonment. Our product candidates may not be considered medically necessary or cost-effective. Any such changes could affect the number of individuals with health coverage. The regime does not, however, extended to procedures such as batch release certification. Among the areas of absence of mutual recognition are batch testing and batch release. However, we cannot ensure that EHS liabilities will not develop in the future. We consider our relationship with our employees to be good. Some of these factors are outside of our control. Such an outcome could have a material adverse effect on our business. Similar extensions of patent term are available in Europe and other jurisdictions. A number of cell and gene therapy products recently have been approved by the FDA. We expect our operating results to be subject to quarterly fluctuations. Accordingly, both state and federal courts have jurisdiction to entertain such claims.