Public comment period · §3
Draft monograph: semaglutide, version 3 — 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-SEMAGLUTIDE-/003 | Quentin Gwynne-Sarpong industry | The document should not describe uses outside the approved indication | Not accepted |
| DRAFT-SEMAGLUTIDE-/009 | Dr Rukayat Zaleski-Mbeki | Registered trials that never reported are absent from the monograph | Accepted |
| DRAFT-SEMAGLUTIDE-/004 | Dr Wolfram Kaltenbach-Mensah | Mechanistic claims for a peptide fragment are carried without evidence that the fragment acts as described | Accepted |
| DRAFT-SEMAGLUTIDE-/010 | Rosalind Petrossian | The search date is not on the face of the document | Accepted |
| DRAFT-SEMAGLUTIDE-/013 | Dr Hyacinth Oyelaran-Steen | The monograph does not tell a reader that a stated mass may be substantially counter-ion and water | Accepted |
| DRAFT-SEMAGLUTIDE-/002 | Dr Zebedee Zaleski-Mbeki | The absence of a rare harm in the trial set is presented as reassurance | Accepted |
| DRAFT-SEMAGLUTIDE-/001 | Dr Ottoline Fitzgerald-Nwosu | Adverse event frequencies are given without the denominator or the exposure period | Accepted |
| DRAFT-SEMAGLUTIDE-/005 | Dr Ludmila Tollemache | Evidence for one member of the class is presented as evidence for this compound | Accepted |
| DRAFT-SEMAGLUTIDE-/008 | Dr Liesbeth Quenneville | The indication table mixes approved indications with uses for which the compound is merely supplied | Accepted |
| DRAFT-SEMAGLUTIDE-/012 | Professor Ekaterina Voskresenskaya-Hill | Regulatory status is stated without naming the jurisdiction | Accepted |
| DRAFT-SEMAGLUTIDE-/007 | Dr Dmitri Nordhagen | A sortable table implies a comparison the underlying data do not support | Noted, no amendment |
| DRAFT-SEMAGLUTIDE-/014 | Dr Amara Vandergraaf industry | Two factual descriptions of the sponsor's programme are inaccurate | Accepted |
| DRAFT-SEMAGLUTIDE-/006 | Dr Jolyon Grünbaum-Sowande | A superseded version should remain reachable from the version that replaced it | Noted, no amendment |
| DRAFT-SEMAGLUTIDE-/011 | Dr Prosper Vercingetorix | Trials are described as terminated where they completed as planned | Accepted in part |
| 14 submissions in total. | |||
§3.2Summary by disposition
Table 2. Counts by disposition, with the meaning of each.
| Disposition | Count | Meaning |
|---|---|---|
| Accepted | 10 | 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 | 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 | 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-SEMAGLUTIDE-/009. 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.
- Mechanistic claims for a peptide fragment are carried without evidence that the fragment acts as… — arising from DRAFT-SEMAGLUTIDE-/004. 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.
- The search date is not on the face of the document — arising from DRAFT-SEMAGLUTIDE-/010. The search date is now printed adjacent to every certainty rating and is carried in the document metadata, so that the interval between the search and the reading is visible without reference to the methods section.
- The monograph does not tell a reader that a stated mass may be substantially counter-ion and water — arising from DRAFT-SEMAGLUTIDE-/013. The monograph now states, at the point where vial contents are first mentioned, that a mass figure is uninterpretable unless it states whether it is peptide content or total solids, and cross-references the content standard in the analytical series.
- The absence of a rare harm in the trial set is presented as reassurance — arising from DRAFT-SEMAGLUTIDE-/002. 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.
- Adverse event frequencies are given without the denominator or the exposure period — arising from DRAFT-SEMAGLUTIDE-/001. Every reported frequency now carries the number of participants, the number of events and the exposure period, and comparator-arm figures are reported alongside rather than in a separate table.
- Evidence for one member of the class is presented as evidence for this compound — arising from DRAFT-SEMAGLUTIDE-/005. 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 indication table mixes approved indications with uses for which the compound is merely supplied — arising from DRAFT-SEMAGLUTIDE-/008. The indication table now carries a status column with three values, approved, under investigation and supplied without trial evidence, and the value is stated for every row. Rows in the third category also state that no certainty rating is assigned because…
- Regulatory status is stated without naming the jurisdiction — arising from DRAFT-SEMAGLUTIDE-/012. Every regulatory status statement now names the authority, states the date on which the status was verified, and is recorded per jurisdiction rather than as a single global assertion.
- Two factual descriptions of the sponsor's programme are inaccurate — arising from DRAFT-SEMAGLUTIDE-/014. 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…
- Trials are described as terminated where they completed as planned — arising from DRAFT-SEMAGLUTIDE-/011. 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.
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-005/3 · https://compoundevidence.com/comment-periods/draft-semaglutide-monograph-v3/disposition/ · retrieved 30 July 2026