Comment from Clarianne Jimenez
AnonymousSupportAcademic
Summary: Dr. Clarianne I. Jimenez, an academic researcher and educator, argues that the preclinical evidence for Emideltide (DSIP) and KPV warrants a defined research pathway rather than permanent foreclosure from the Section 503A Bulk Drug Substances List. She requests that the Committee weigh the existing scientific signals as a basis for structured investigational studies to resolve current gaps in safety and effectiveness.
I respectfully submit the attached public comments concerning Emideltide (DSIP) and KPV, both under consideration for the Section 503A Bulk Drug Substances List at the July 23 to 24, 2026 Pharmacy Compounding Advisory Committee meeting. I write in an individual academic capacity as a researcher and educator. My comments do not assert that either substance is proven safe and effective, and they do not request inclusion on the strength of the current record. Rather, each concedes the genuine gaps in the evidence and respectfully asks the Committee to weigh the existing preclinical and mechanistic findings as a coherent scientific signal that warrants a defined research pathway, rather than treating those gaps as a basis for permanent foreclosure. These comments are offered in the interest of a complete scientific record and not on behalf of any nominator or commercial party.