Thursday, June 24, 2021 1:59:00 AM
Not commenting as an authority but as a curbside consult… Standard procedure for new drugs is to run animal trials (mouse and dog) to test toxicology prior to submitting IND for human testing. I have not researched what the FDA is looking at when measuring toxicology at the DNA level (unsure if they are looking for changes to the DNA sequence and/ or DNA structure) but Aviptadil is an amino acid construct so it should be exempt from screenings required of nucleic acid based therapies. Even if DNA toxicology testing is a new blanket protocol for all new drugs I don’t see the FDA requiring RLFTF/NRXP to backtrack to animal studies since Aviptadil has already been used in humans even prior to COVID thus we can observe and test changes to human DNA instead of going back to animal models. There are even individuals who have been injecting Aviptadil directly into their phallus for years as an ED treatment but nothing the FDA does surprises me anymore. My opinion.
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