Public comment period · §3
Draft monograph: MOTS-c — 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-MOTS-C-MONOG/001 | Dr Wojciech Kaltenbach-Mensah | The monograph should state what the compound costs | Not accepted |
| DRAFT-MOTS-C-MONOG/002 | Dr Perpetua Haverkamp-Diallo industry | Two factual descriptions of the sponsor's programme are inaccurate | Accepted |
| DRAFT-MOTS-C-MONOG/003 | Thaddeus Isaksen-Balogun | Point estimates are given without an interval | Accepted in part |
| DRAFT-MOTS-C-MONOG/004 | Dr Melisande Kirkpatrick-Ola | Every contributing trial shares one sponsor and the monograph does not say so | Accepted |
| DRAFT-MOTS-C-MONOG/005 | Dr Zebedee Zaleski-Mbeki | Anti-drug antibody data are omitted | Accepted in part |
| DRAFT-MOTS-C-MONOG/006 | Dr Anselm Thorsby-Nakamura | A purity figure from a certificate is quoted as though it were a content figure | Accepted |
| DRAFT-MOTS-C-MONOG/007 | Dr Valentin Tollemache | What happens when the compound is stopped is not addressed | Accepted |
| DRAFT-MOTS-C-MONOG/008 | Dr Eamon Immelmann | The monograph does not tell a reader that two vials of the same compound may not contain the same thing | Accepted |
| 8 submissions in total. | |||
§3.2Summary by disposition
Table 2. Counts by disposition, with the meaning of each.
| Disposition | Count | Meaning |
|---|---|---|
| Accepted | 5 | 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 | 0 | 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
- Two factual descriptions of the sponsor's programme are inaccurate — arising from DRAFT-MOTS-C-MONOG/002. 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…
- Point estimates are given without an interval — arising from DRAFT-MOTS-C-MONOG/003. Every estimate now carries its interval where the source reported one, and where it did not, the estimate is annotated as reported without an interval rather than left to appear as a precise figure.
- Every contributing trial shares one sponsor and the monograph does not say so — arising from DRAFT-MOTS-C-MONOG/004. Sponsor concentration is now stated with the certainty rating, and the monograph records how many independent sponsors contributed evidence to each assessed outcome.
- Anti-drug antibody data are omitted — arising from DRAFT-MOTS-C-MONOG/005. 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.
- A purity figure from a certificate is quoted as though it were a content figure — arising from DRAFT-MOTS-C-MONOG/006. 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.
- What happens when the compound is stopped is not addressed — arising from DRAFT-MOTS-C-MONOG/007. Discontinuation trajectory is now an assessed outcome in every monograph where a contributing trial measured it, and a recorded evidence gap in every monograph where none did, so that its absence is visible rather than silent.
- The monograph does not tell a reader that two vials of the same compound may not contain the same… — arising from DRAFT-MOTS-C-MONOG/008. A standing paragraph now appears at the head of §8 in every monograph, stating that a determination applies to the lot measured and that a label mass is not a determination.
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-067/3 · https://compoundevidence.com/comment-periods/draft-mots-c-monograph/disposition/ · retrieved 30 July 2026