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The committee members who voted yes generally believed the risks to be minimal, while those who voted no tended to worry about safety risks and effectiveness, and expressed concern that adding the peptide to the compounding list would create a false impression that it has been evaluated with the same rigorous standards as an FDA-approved drug

Key gaps include: No large-scale randomised controlled trials in humans the evidence basis for clinical use is extrapolated from animal data and small pilot studies No long-term safety data effects beyond 1216 weeks are not well characterised Variable results in human sleep trials some early human studies showed modest or inconsistent effects on sleep architecture compared to animal data, suggesting the translation may not be linear No FDA approval DSIP is not approved for any therapeutic use in the United States Stability concerns DSIP degrades relatively quickly in circulation

S17 The ATP levels in LLC cells after different treatments