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The FDA peptides vote is days away. This insider expects approval
Description
In episode 74, Jonathan Stern sits down with Dr. Jesse Morse, a board-certified family and sports medicine physician, longtime peptide prescriber who helped assemble safety evidence for the upcoming PCAC review. They discuss the FDA briefing recommending against adding seven peptides to the 503A bulks list and how the 2023 restrictions pushed demand into gray and black markets. Morse breaks down the 7 peptides under review -- BPC-157, TB-500, KPV, MOTS-c, DSIP, Epitalon, and Semax -- including their proposed uses, safety concerns, and his approval odds for each. The conversation also covers peptide efficacy standards, the politics behind the FDA process, and why U.S.-made API could become a major advantage for Hims & Hers.
00:00 - Sponsor: Superpower
01:37 - FDA briefing document
03:24 - Getting peptides back in front of the FDA
08:58 - Prescribing peptides back in 2017
12:42 - Peptides safety data
16:08 - BPC-157 deep-dive and odds for approval
22:56 - TB-500 deep-dive
26:15 - Approval odds for the other 5 peptides
31:02 - Peptide efficacy data
34:40 - FDA politics and final decisions
40:30 - Peptides market size
42:48 - Training the doctors
47:20 - Shipping hurdles and gray-market risk
53:25 - Why peptides could reshape healthcare
Disclaimer: This podcast is for informational and entertainment purposes only. Nothing discussed should be considered financial, investment, or legal advice. Always consult with a qualified professional before making financial decisions.