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$HIMS 🚨 NEEDHAM'S RYAN MACDONALD SAYS HIS "BASE CASE" IS THAT PEPTIDES WILL BE APPROVED Jonathan Stern: "I have seen a ton of alarmist tweets saying, 'RIP to the peptide bros', essentially. And what you're saying, Ryan, is that it's really not that simple." "We have a process here....

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Hims House

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The FDA’s recent recommendations on peptides are a *significant* setback for new and existing companies being built around the expectation that they will be able to sell compounded peptides. That’s because the 503A Bulks List is basically a pathway that lets compounding pharmacies use certain bulk drug substances to compound drugs for patient-specific prescriptions. The FDA is recommending against adding seven popular peptides to the list. Unless RFK goes against the FDA staff recommendation, these companies’ path to legally compounding and selling peptides becomes very difficult.

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$HIMS THE CAT IS OUT OF THE BAG WITH PEPTIDES Jonathan: "There is no going back to 2010. These have taken over the cultural consciousness and are here to stay... What happens, though, if the 7 peptides are not approved?" Jesse Morse, M.D.: "So here's the problem. The demand is there. Right now, the supply is the problem, and part of that supply is purity and safety." "Millions of people are taking peptides every day in the United States." "Less than 5% of them, if I were to guess, are being compounded by American pharmacies." "That means 95% of the peptides that are not GLPs are being ordered from some random website or picked up at a bodega in New York." "The FDA has to see this, and they have to say, 'Hey, I understand this is not ideal, and we don't have 10 years of beautiful data. But unfortunately, this is the situation we're in.' "
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$HIMS THE CAT IS OUT OF THE BAG WITH PEPTIDES Jonathan: "There is no going back to 2010. These have taken over the cultural consciousness and are here to stay... What happens, though, if the 7 peptides are not approved?" Jesse Morse, M.D.: "So here's the problem. The demand is there. Right now, the supply is the problem, and part of that supply is purity and safety." "Millions of people are taking peptides every day in the United States." "Less than 5% of them, if I were to guess, are being compounded by American pharmacies." "That means 95% of the peptides that are not GLPs are being ordered from some random website or picked up at a bodega in New York." "The FDA has to see this, and they have to say, 'Hey, I understand this is not ideal, and we don't have 10 years of beautiful data. But unfortunately, this is the situation we're in.' "

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