Public comment period · §3
Draft monograph: Ecnoglutide — 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-ECNOGLUTIDE-/001 | Dr Theodora Ingelbrecht | Evidence for one member of the class is presented as evidence for this compound | Accepted |
| DRAFT-ECNOGLUTIDE-/002 | Dr Yusuf Whitmarsh-Obi | Every contributing trial shares one sponsor and the monograph does not say so | Accepted |
| DRAFT-ECNOGLUTIDE-/003 | Dr Prosper Vercingetorix | The monograph should state what the compound costs | Not accepted |
| DRAFT-ECNOGLUTIDE-/004 | Dr Eamon Immelmann | The analytical section assumes a reference standard that is not generally available | Accepted |
| DRAFT-ECNOGLUTIDE-/005 | Quentin Whitmarsh-Obi | A superseded version should remain reachable from the version that replaced it | Noted, no amendment |
| DRAFT-ECNOGLUTIDE-/006 | Dr Henrike Jastrzębska | The analytical section is longer than the clinical assessment it accompanies | Accepted in part |
| DRAFT-ECNOGLUTIDE-/007 | Dr Ndidi Ravensworth-Ilunga | Registered trials that never reported are absent from the monograph | Accepted |
| 7 submissions in total. | |||
§3.2Summary by disposition
Table 2. Counts by disposition, with the meaning of each.
| Disposition | Count | Meaning |
|---|---|---|
| Accepted | 4 | 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 | 1 | 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 | 1 | 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 | 1 | 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
- Evidence for one member of the class is presented as evidence for this compound — arising from DRAFT-ECNOGLUTIDE-/001. Class-level inferences are now labelled at the point of use, are excluded from the certainty rating for the compound, and are reported in a separate subsection stating which compound the underlying evidence concerns.
- Every contributing trial shares one sponsor and the monograph does not say so — arising from DRAFT-ECNOGLUTIDE-/002. Sponsor concentration is now stated with the certainty rating, and the monograph records how many independent sponsors contributed evidence to each assessed outcome.
- The analytical section assumes a reference standard that is not generally available — arising from DRAFT-ECNOGLUTIDE-/004. The analytical section now states whether a reference standard is in general circulation for this compound and, where it is not, states which determinations remain possible and which become qualitative. A content figure obtained without a reference standard…
- The analytical section is longer than the clinical assessment it accompanies — arising from DRAFT-ECNOGLUTIDE-/006. 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.
- Registered trials that never reported are absent from the monograph — arising from DRAFT-ECNOGLUTIDE-/007. 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.
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-047/3 · https://compoundevidence.com/comment-periods/draft-ecnoglutide-monograph/disposition/ · retrieved 30 July 2026