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The product presentation appeared professional

In contrast, Kashi et al

Emerging therapies, including PCSK9 inhibitors, inclisiran, bempedoic acid, and investigational RNA-based Lp(a)-lowering agents, illustrate how better biomarker definition can guide more targeted cardiovascular risk reduction

The absence of FDA approval means no verified manufacturing standards, dosing protocols, or safety benchmarks exist for human use

The question isn't whether the rules changed
