Public comment period · §3
Draft monograph: SS-31 (elamipretide) — disposition
The disposition of every submission and the amendments that resulted.
§3Disposition and amendments
§3.1Disposition table
Table 1. Every submission with its disposition. Each row links to the submission in full.
| Reference | Respondent | Point raised | Disposition |
|---|---|---|---|
| DRAFT-SS-31-MONOGR/002 | Dr Eamon Sandringham-Adu | The document should state what a reader ought to do | Not accepted |
| DRAFT-SS-31-MONOGR/007 | Dr Wojciech Kaltenbach-Mensah | The preclinical section is extensive and the clinical section is not | Accepted in part |
| DRAFT-SS-31-MONOGR/012 | Dr Xenia Uttridge | The monograph should state what the compound costs | Not accepted |
| DRAFT-SS-31-MONOGR/005 | Dr Abimbola Sotomayor-Ekwueme | The analytical section is longer than the clinical assessment it accompanies | Accepted in part |
| DRAFT-SS-31-MONOGR/011 | Dr Nadezhda Lavrentiev industry | Two factual descriptions of the sponsor's programme are inaccurate | Accepted |
| DRAFT-SS-31-MONOGR/010 | Dr Anselm Thorsby-Nakamura | Registered trials that never reported are absent from the monograph | Accepted |
| DRAFT-SS-31-MONOGR/008 | Dr Wolfram Tollemache | A purity figure from a certificate is quoted as though it were a content figure | Accepted |
| DRAFT-SS-31-MONOGR/014 | Dr Prosper Vercingetorix | Every contributing trial shares one sponsor and the monograph does not say so | Accepted |
| DRAFT-SS-31-MONOGR/009 | Dr Torvald Kettlewell | The monograph should not describe how the compound is supplied outside a regulated route | Noted, no amendment |
| DRAFT-SS-31-MONOGR/013 | Professor Ekaterina Voskresenskaya-Hill | What happens when the compound is stopped is not addressed | Accepted |
| DRAFT-SS-31-MONOGR/006 | Dr Ulysses Bellingham-Ojo | A superseded version should remain reachable from the version that replaced it | Noted, no amendment |
| DRAFT-SS-31-MONOGR/003 | Ivo Mountstephen | The compound is supplied under names the monograph does not list | Accepted |
| DRAFT-SS-31-MONOGR/016 | Rosalind Petrossian | Mechanistic claims for a peptide fragment are carried without evidence that the fragment acts as described | Accepted |
| DRAFT-SS-31-MONOGR/004 | Dr Wilhelmina Quaresma | Doses are expressed in units that differ between sections | Accepted |
| DRAFT-SS-31-MONOGR/015 | Dr Rukayat Zaleski-Mbeki industry | The document should not describe uses outside the approved indication | Not accepted |
| DRAFT-SS-31-MONOGR/001 | Dr Theodora Trelawney | The document set should be published in translation | Not accepted |
| 16 submissions in total. | |||
§3.2Summary by disposition
Table 2. Counts by disposition, with the meaning of each.
| Disposition | Count | Meaning |
|---|---|---|
| Accepted | 8 | The submission is accepted and the draft is amended as proposed. The amendment is recorded in the amendment log of the document it changed and is traceable to the numbered submission. |
| Accepted in part | 2 | Part of the submission is accepted and part is not. The secretariat response states which part is which and on what ground the remainder was declined. |
| Noted, no amendment | 2 | The submission raises a point the Institute accepts but that does not require a change to the draft, most often because the draft already states it elsewhere. The location is given in the response. |
| Not accepted | 4 | The submission is not accepted. The secretariat response gives the reason. A submission that is not accepted remains published in full; the Institute does not remove a submission because it disagrees with it. |
§3.3Resulting amendments
- The preclinical section is extensive and the clinical section is not — arising from DRAFT-SS-31-MONOGR/007. The preclinical section is reduced in length, placed after the clinical assessment rather than before it, and opens with a standing statement that an effect observed in an animal model is not a clinical outcome and does not support a certainty rating.
- The analytical section is longer than the clinical assessment it accompanies — arising from DRAFT-SS-31-MONOGR/005. The analytical section is reduced to compound-specific content and cross-references the relevant standards for the general procedure, which shortens it substantially without removing what is not available elsewhere.
- Two factual descriptions of the sponsor's programme are inaccurate — arising from DRAFT-SS-31-MONOGR/011. The trial status now reads as completed at a pre-specified interim analysis, with the analysis identified, and the dose is stated in the unit used in the approved labelling. The submission is identified as an industry submission on its face in accordance with…
- Registered trials that never reported are absent from the monograph — arising from DRAFT-SS-31-MONOGR/010. The trial list now includes every registered trial the Institute identified, with its reporting status stated, and the monograph reports the proportion of registered trials for which no result has been posted or published.
- A purity figure from a certificate is quoted as though it were a content figure — arising from DRAFT-SS-31-MONOGR/008. Purity and content are now reported in separate rows with separate definitions, and the monograph states that a purity figure sets no bound on content and that a content figure requires a determination against a standard of assigned content.
- Every contributing trial shares one sponsor and the monograph does not say so — arising from DRAFT-SS-31-MONOGR/014. Sponsor concentration is now stated with the certainty rating, and the monograph records how many independent sponsors contributed evidence to each assessed outcome.
- What happens when the compound is stopped is not addressed — arising from DRAFT-SS-31-MONOGR/013. Discontinuation trajectory is now an assessed outcome in every monograph where a contributing trial measured it, and a recorded evidence gap in every monograph where none did, so that its absence is visible rather than silent.
- The compound is supplied under names the monograph does not list — arising from DRAFT-SS-31-MONOGR/003. The synonym list is extended to include every name the Institute can evidence from a document it holds, each recorded with its source. Names asserted without a supporting document are not added, and the distinction is stated at the head of the list.
- Mechanistic claims for a peptide fragment are carried without evidence that the fragment acts as… — arising from DRAFT-SS-31-MONOGR/016. Mechanistic claims not traceable to a primary source are removed, and those retained carry their source and a statement of whether the underlying work was conducted in vitro, in animals or in humans.
- Doses are expressed in units that differ between sections — arising from DRAFT-SS-31-MONOGR/004. A single dose unit is now used throughout each monograph, with the source unit retained in parentheses wherever a conversion was applied, and every conversion is stated rather than performed silently.
References cited on this page
References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.
- International Organization for Standardization. ISO/IEC 17025:2017 General Requirements for the Competence of Testing and Calibration Laboratories. ISO/IEC Standard 2017;3rd edition. identifier not held by the Institute
Identifiers are reproduced only where the Institute holds them. Where a digital object identifier or PubMed identifier is not shown, the Institute has recorded the journal and year and has not constructed an identifier.
Compound Evidence Institute · CEI-CP-076/3 · https://compoundevidence.com/comment-periods/draft-ss-31-monograph/disposition/ · retrieved 30 July 2026