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The GHK-Cu decision reflects a broader shift in how the FDA is approaching peptides with established safety records and clear endogenous precedent (i.e., the body already makes them)
Finally, studies published prior to 2018 were included only if they provided foundational pharmacokinetic or pharmacodynamic data on GLP-1 receptor distribution in the CNS or on the initial development of acylated GLP-1 analogs
That is one reason longer phase 3 trials drew so much interest, since the ceiling had not announced itself yet
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