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This is notably lower than the 6.21 percent average standard deviation observed for rarely utilized orphan drugs, as reported in the CY 2024 PFS final rule (88 FR 52393)

TB-500 (thymosin beta-4 fragment) influences actin polymerization and cytoskeletal organization

This is associated with impaired mitochondrial function, dysregulated OXPHOS, and increased ROS

All right, so in my view, I'll bury the lead and just tell you I think that these results are at high risk of being fully explained by immortal time bias