Our Phase 2b/3 trial, Saturn-1, commenced in September 2020. In December 2020 we had a Type C meeting with the FDA for TP-03. In relation to malaria, we may conduct our Phase 1/2 trial outside the United States. Annual diagnoses rates have been maintained at similar levels since 2015. TP-03 was generally well tolerated throughout these trials. This may in turn provide herd protection against the spread of malaria. These blepharitis cases are referred to Demodex blepharitis. Fourteen of the 15 subjects who received treatment completed the trial through Day 28. No subjects discontinued the trial due to adverse events. This subject did not return for their follow-up visit on Day 42. Early symptoms include a localized rash, fever and fatigue. To do this, we are developing TP-05 as an oral formulation of lotilaner. We in-license certain of such patents and patent applications from Elanco. FDA adjusts the PDUFA user fees on an annual basis. If the FDA concludes that a REMS is needed, the NDA sponsor must submit a proposed REMS. Additionally, the Further Consolidated Appropriations Act of 2020, Pub. Our telephone number is (949) 409-9820. We do not maintain "key person" insurance for any of our executives or employees. Our product candidates still require significant testing. We have not conducted any preclinical studies in rosacea with TP-04 to date. We may not be successful in accomplishing these required tasks. Such changes carry the risk that they will not achieve these intended objectives. Some of these third parties may terminate their engagements with us at any time. As a result, we may not obtain access to these facilities on a priority basis or at all. The Bayh-Dole Act also provides federal agencies with "march-in rights". Therefore, coverage and adequate reimbursement is critical to new product acceptance. We could be subject to securities class action litigation.
