Public comment period · §3
Draft monograph: CagriSema (cagrilintide with semaglutide) — 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-CAGRISEMA-MO/001 | Dr Fitzwilliam Danquah-Öberg | A purity figure from a certificate is quoted as though it were a content figure | Accepted |
| DRAFT-CAGRISEMA-MO/002 | Dr Henrike Jastrzębska | Evidence for one member of the class is presented as evidence for this compound | Accepted |
| DRAFT-CAGRISEMA-MO/003 | Dr Evander Ashworth-Danquah | A sortable table implies a comparison the underlying data do not support | Noted, no amendment |
| DRAFT-CAGRISEMA-MO/004 | Dr Georgiana Mountstephen | The monograph should not describe how the compound is supplied outside a regulated route | Noted, no amendment |
| DRAFT-CAGRISEMA-MO/005 | Dr Lorcan Trelawney | The absence of a rare harm in the trial set is presented as reassurance | Accepted |
| 5 submissions in total. | |||
§3.2Summary by disposition
Table 2. Counts by disposition, with the meaning of each.
| Disposition | Count | Meaning |
|---|---|---|
| Accepted | 3 | 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 | 0 | 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 | 0 | 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
- A purity figure from a certificate is quoted as though it were a content figure — arising from DRAFT-CAGRISEMA-MO/001. 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.
- Evidence for one member of the class is presented as evidence for this compound — arising from DRAFT-CAGRISEMA-MO/002. 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.
- The absence of a rare harm in the trial set is presented as reassurance — arising from DRAFT-CAGRISEMA-MO/005. 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.
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-043/3 · https://compoundevidence.com/comment-periods/draft-cagrisema-monograph/disposition/ · retrieved 30 July 2026