Our clinical-stage pipeline includes brensocatib and TPIP. In the fourth quarter of 2020, we launched ARIKAYCE in Germany. 8226; We plan to commercialize ARIKAYCE in certain countries in Europe. In March 2020, we submitted a JNDA to Japan\'s MHLW. The JMDN was accepted and Lamira is authorized for use in Japan. The study is expected to enroll approximately 100 patients. Patients were treated for up to 28 days. 8,679,532 (expires December 5, 2026)•US Patent No. 9,255,064 has claims reciting hexadecyl-treprostinil, and other treprostinil prodrugs. The master services agreement has an initial term of five years. Further post-approval requirements are discussed below. The FDA must respond within 60 days of receipt of the request. ARIKAYCE has been designated as a QIDP for NTM lung disease. PIPs are subject to modifications from time to time, when they no longer are workable. We had 403 employees in the US, 74 employees in Europe and 44 employees in Japan. In addition, independent foundations may assist with out-of-pocket financial obligations. These pressures could negatively affect our business. Any such failure to obtain regulatory approvals may materially adversely affect us. These processes are complex, lengthy, expensive, resource intensive and uncertain. Accordingly, it is possible that our practices may be challenged under these laws. Our reputation could also suffer. We previously faced a shareholder suit following a decline in our stock price.