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The docket closes on July 22, 2026, and comments submitted after July 9 but before the docket closes will still be taken into consideration by FDA

Genuine pharmacokinetic differences in a particular preparation

People with impaired FMO3 activity either due to genetic variants known to cause trimethylaminuria or due to liver disease have reduced ability to clear TMA

I spent months doing computational modeling [to design peptides with amino acid structures that would engage with the receptors] within a narrow category as I couldnt choose a molecule that had previously been tested in a clinical context [because it could not then be legally marketed as a dietary supplement]