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In its initial announcements, CMS indicated that the GLP-1 Bridge program would run from July 1, 2026, through the end of the year, with the BALANCE Model beginning in January 2027

There is thus a lack of data to currently see a clear path forward for this drug, but future studies would need to assess the safety and feasibility of this therapeutic approach in this high-risk patient population in Phase 1 or 2 clinical trials

By preserving the native conformational epitopes of authentic virions while eliminating infectious genetic material, VLPs elicit potent humoral and cellular immune responses without the risks associated with replication

Your chances of success increase significantly with each resubmission, so be sure to keep trying