In addition, we are pursuing discovery efforts in diseases that affect the liver. We have designed MRT5005 to be inhaled via a handheld nebulizer. This process of translation is designed to continue until the mRNA is expended. 8226; Targeting Lower Immunogenicity. CF is caused by dysfunctional or missing CFTR protein. There were no treatment-emergent serious adverse events. MRT5005 was well-tolerated in all of our preclinical studies at all doses. We are also currently conducting discovery activities to advance our scientific platform. The Supply Agreement will remain in effect until terminated in accordance with its terms. Trade secrets and know-how can be difficult to protect. In addition, on May 30, 2018, the Right to Try Act was signed into law. The FDA may request additional information rather than accept the application for filing. Coverage policies and third-party reimbursement rates may change at any time. Other legislative changes have been proposed and adopted since the ACA was enacted. The EMA has indicated that the system will go live in December 2021. Orphan Drug Designation and Exclusivity Regulation (EC) No. Direct-to-consumer advertising of prescription medicines is prohibited across the EU. As a result, increasingly high barriers are being erected to the entry of new products. All of our employees are located in the United States. We have never generated revenue from product sales and may never be profitable. In addition, our product candidates, if approved, may not achieve commercial success. In addition, the resulting clinical data and results may be difficult to analyze. The number of patients may turn out to be lower than expected. MRT5500 has been selected as the lead candidate for a vaccine against SARS-CoV-2. In addition, there is a natural transition period when a new third party commences work. Such delays could materially adversely affect our business. Designation as a breakthrough therapy is within the discretion of the FDA. A broad range of legislative measures also have been introduced at the federal level. There is also no assurance that any covering analyst will provide favorable coverage.
