We do not expect an approval decision under the MDR until 2022, if ever. Accordingly, we may never achieve a profitable level of operations in the future. In general, these processes do not require additional clinical trials. No subjects exhibited an immune response to INTERCEPT-treated RBCs. Enrollment in the ReCePI study began in 2019. Our patents expire at various dates between 2021 and 2037. Illuminators and replacement parts do not have regulated expiration dates. In March 2020, we received an extension of the CE Mark approval to 2024, under the MDD. In addition, of our U.S. employees, approximately 41% identify as non-white. There may be additional risks faced by our business. This is a new business model with which we have no experience. In addition, our labeling claims may not be consistent across markets. Significant delays in clinical testing could also materially impact our clinical trials. Other regulatory authorities outside of the U.S. may also require post-marketing studies. We may be unable to ensure that our distributors are compliant with such standards. We have not been notified by Nova of their intention to terminate the agreement. As 56 such, certain studies and trials may be delayed for an extended period of time. Item 1B. Unresolved Staff Comments None.
