Public comment period · §3
Draft monograph: Maridebart cafraglutide — 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-MARIDEBART-C/002 | Professor Ekaterina Voskresenskaya-Hill | Registered trials that never reported are absent from the monograph | Accepted |
| DRAFT-MARIDEBART-C/007 | Dr Quentin Enthoven | A purity figure from a certificate is quoted as though it were a content figure | Accepted |
| DRAFT-MARIDEBART-C/004 | Dr Amara Vandergraaf | The analytical section assumes a reference standard that is not generally available | Accepted |
| DRAFT-MARIDEBART-C/001 | Dr Prosper Vercingetorix | Trials are described as terminated where they completed as planned | Accepted in part |
| DRAFT-MARIDEBART-C/009 | Dr Georgiana Mountstephen | The absence of a rare harm in the trial set is presented as reassurance | Accepted |
| DRAFT-MARIDEBART-C/006 | Dr Séverine Oduya-Kaltenbrunner | Guidance on lyophilised storage is missing | Noted, no amendment |
| DRAFT-MARIDEBART-C/003 | Dr Hyacinth Oyelaran-Steen | The same concept is given three different names in one document | Accepted |
| DRAFT-MARIDEBART-C/005 | Dr Liesbeth Achterberg | Quantitative claims are reproduced without the method that produced them | Accepted |
| DRAFT-MARIDEBART-C/008 | Dr Emiliana Ollerenshaw | The monograph should state what the compound costs | Not accepted |
| 9 submissions in total. | |||
§3.2Summary by disposition
Table 2. Counts by disposition, with the meaning of each.
| Disposition | Count | Meaning |
|---|---|---|
| Accepted | 6 | 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
- Registered trials that never reported are absent from the monograph — arising from DRAFT-MARIDEBART-C/002. 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-MARIDEBART-C/007. 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.
- The analytical section assumes a reference standard that is not generally available — arising from DRAFT-MARIDEBART-C/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…
- Trials are described as terminated where they completed as planned — arising from DRAFT-MARIDEBART-C/001. Trial status now uses a fixed vocabulary defined in the glossary, and where the reason for stopping is not evidenced by a document the Institute holds, the status is recorded as stopped with the reason not established rather than assigned.
- The absence of a rare harm in the trial set is presented as reassurance — arising from DRAFT-MARIDEBART-C/009. Wherever the monograph reports that an event was not observed, it now states the total exposure and the frequency the contributing trials could have detected, so that the absence is read as the limit of the evidence rather than as a finding.
- The same concept is given three different names in one document — arising from DRAFT-MARIDEBART-C/003. A single term is now used throughout for each defined concept, and the glossary entry is linked at first use within each section rather than once per document.
- Quantitative claims are reproduced without the method that produced them — arising from DRAFT-MARIDEBART-C/005. Every quantitative claim now carries the determination that produced it at the point of use, and figures obtained by non-comparable methods are no longer presented in the same row or sentence.
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-064/3 · https://compoundevidence.com/comment-periods/draft-maridebart-cafraglutide-monograph/disposition/ · retrieved 30 July 2026