Public comment period · §3
Draft monograph: Semaglutide, oral — 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-ORAL-SEMAGLU/001 | Dr Frideswide Nordhagen | Doses are expressed in units that differ between sections | Accepted |
| DRAFT-ORAL-SEMAGLU/002 | Leonhard Achterberg | Anti-drug antibody data are omitted | Accepted in part |
| DRAFT-ORAL-SEMAGLU/003 | Dr Jerome Lavrentiev | The absence of paediatric evidence is not stated where a reader would look for it | Accepted |
| DRAFT-ORAL-SEMAGLU/004 | Dr Rurik Haverkamp-Diallo | The monograph should not describe how the compound is supplied outside a regulated route | Noted, no amendment |
| DRAFT-ORAL-SEMAGLU/005 | Dr Eamon Immelmann | The analytical section assumes a reference standard that is not generally available | Accepted |
| DRAFT-ORAL-SEMAGLU/006 | Dr Marisol Dunmore-Ekpo | The certainty rating for the principal assessed outcome cannot be traced to the contributing trials | Accepted |
| DRAFT-ORAL-SEMAGLU/007 | Dr Melisande Kirkpatrick-Ola | Open-label extension data are presented alongside randomised data without distinction | Accepted |
| DRAFT-ORAL-SEMAGLU/008 | Dr Evander Whitmarsh-Obi | Quantitative claims are reproduced without the method that produced them | Accepted |
| DRAFT-ORAL-SEMAGLU/009 | Professor Ekaterina Voskresenskaya-Hill | Where the compound is a glucagon-like peptide-1 receptor agonist, the cardiovascular outcome evidence should… | Accepted in part |
| 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 | 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 | 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 | 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
- Doses are expressed in units that differ between sections — arising from DRAFT-ORAL-SEMAGLU/001. 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.
- Anti-drug antibody data are omitted — arising from DRAFT-ORAL-SEMAGLU/002. Anti-drug antibody incidence and any reported association with loss of effect are now reported where measured, and recorded as not measured where the contributing trials did not assess them.
- The absence of paediatric evidence is not stated where a reader would look for it — arising from DRAFT-ORAL-SEMAGLU/003. The population table now carries a paediatric row in every monograph, and where evidence exists the trials are named.
- The analytical section assumes a reference standard that is not generally available — arising from DRAFT-ORAL-SEMAGLU/005. 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 certainty rating for the principal assessed outcome cannot be traced to the contributing trials — arising from DRAFT-ORAL-SEMAGLU/006. Each assessed outcome now carries its downgrade domains in the summary-of-findings row, with a short statement of the judgement made in each, so that the rating can be checked domain by domain against the contributing trials.
- Open-label extension data are presented alongside randomised data without distinction — arising from DRAFT-ORAL-SEMAGLU/007. Extension data now appear in a separate table headed as uncontrolled follow-up, with a standing note on differential withdrawal.
- Quantitative claims are reproduced without the method that produced them — arising from DRAFT-ORAL-SEMAGLU/008. 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.
- Where the compound is a glucagon-like peptide-1 receptor agonist, the cardiovascular outcome… — arising from DRAFT-ORAL-SEMAGLU/009. Cardiovascular outcomes are now an assessed outcome with their own certainty rating in every monograph for which a dedicated cardiovascular outcome trial of that compound has reported, and are recorded as not assessed elsewhere.
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-069/3 · https://compoundevidence.com/comment-periods/draft-oral-semaglutide-monograph/disposition/ · retrieved 30 July 2026