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Trimethylamine-N-Oxide pathway: a potential target for the treatment of MAFLD
The solution should be perfectly clear
Currently, in the United States, the FDA may grant three years of exclusivity to a new formulation, for which our GB-102 and GB-103 products would qualify, and other changes to a drug, such as the addition of a new indication to the package insert, if the application contains reports of new clinical investigations (other than bioavailability studies) conducted or sponsored by the sponsor that were essential to the approval of the application
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That doesn't automatically make compounded products unsafe but potency can vary, dosing errors are more likely, and source quality matters enormously
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