Overall Benefit. The Grantee certifies that the aggregate use of the Grant funds shall principally benefit persons of low and moderate income in a manner that ensures that at least seventy percent (70%) of the amount is expended for activities that benefit such persons.
Overall Benefit. The aggregate use of CDBG funds, including Section 108 guaranteed loans, during program year(s) 2021-2023[a period specified by the grantee of one, two, or three specific consecutive program years], shall principally benefit persons of low and moderate income in a manner that ensures that at least 70 percent of the amount is expended for activities that benefit such persons during the designated period.
Overall Benefit. Risk Conclusion Revised the overall benefit risk conclusion. To clarify benefit-risk assessments based on changes in above sections Section 4.4 End of Study Definition Clarified early termination and end of study definitions. To provide clarity for these definitions Section 5.0 Study Population (Sections 5.1, 5.2, 5.3, 5.4) • Revised inclusion and exclusion criteria for all patients. • Added eligibility criteria for Groups 1, 2 and 3 • Removed inclusion and exclusion criteria that were not applicable To clarify eligibility criteria for the different patient groups Section 6 Study Intervention, Section 6.1 Study Intervention Administered, Section 6.2 Preparation/ Handling/ Storage/ Accountability Added language describing the tablet formulation of the study drug that will be introduced in this study once the tablet formulation becomes available. To incorporate tablet form
Overall Benefit. Risk Conclusion Considering the severity of the disease, the continuing anemia and reticulocytosis in some patients on C5 inhibitors, and the lack of an effective oral therapy alternative for PNH patients, there is a clear need for new therapies to improve PNH management. ALXN2050 is expected to provide improved efficacy based on its mechanism of action and optimized PK profile. Based on the preclinical and clinical data available to date, the benefit-risk profile remains favorable for advancing the development of ALXN2050 for the treatment of patients with PNH.
Overall Benefit. To the best of its knowledge, the aggregate use by the entitlement community of CDBG Funds including section 108 guaranteed loans during program year(s) 2010, 2011, 2013 (a period specified by the local government consisting of one, two, or three specific consecutive program years), shall principally benefit persons of low and moderate income in a manner that ensures that at least 70 percent of the amount is expended for activities that benefit such persons during the designated period;
