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Rather, we continue to believe that our current process, wherein we evaluate all evidence submitted for each device pass-through application as it applies to the nominated device, is appropriate and consistent with the regulatory requirements

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(PubMed) If AOD-9604 re-enters mainstream clinical availability through compliant channels, the most responsible use-case will likely be: carefully selected patients, realistic expectations, body composition focus, and as an adjunctnot a centerpiece

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