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doi: 10.1152/jn.00353.2011

The idea is that this invader will reach the liver cells, and the enclosed gene will initiate production of the protein that would normally restore proper copper metabolism

Comment: The applicant acknowledged that CMS applies a high evidentiary standard for substantial clinical improvement, typically requiring robust clinical data showing improved patient outcomes such as reduced complications, fewer reoperations, faster recovery, or better functional results compared to the current standard of care