Public comment period · §3
Draft monograph: Melanotan-II — 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-MELANOTAN-II/001 | Dr Perpetua Haverkamp-Diallo industry | The document should not describe uses outside the approved indication | Not accepted |
| DRAFT-MELANOTAN-II/002 | Dr Hortensia Larsson-Ekwueme | Adverse event frequencies are given without the denominator or the exposure period | Accepted |
| DRAFT-MELANOTAN-II/003 | Dr Piotr Hollingworth | The preclinical section is extensive and the clinical section is not | Accepted in part |
| DRAFT-MELANOTAN-II/004 | Dr Odalys Thorsby-Nakamura | Trials are described as terminated where they completed as planned | Accepted in part |
| 4 submissions in total. | |||
§3.2Summary by disposition
Table 2. Counts by disposition, with the meaning of each.
| Disposition | Count | Meaning |
|---|---|---|
| Accepted | 1 | 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
- Adverse event frequencies are given without the denominator or the exposure period — arising from DRAFT-MELANOTAN-II/002. 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.
- The preclinical section is extensive and the clinical section is not — arising from DRAFT-MELANOTAN-II/003. The preclinical section is reduced in length, placed after the clinical assessment rather than before it, and opens with a standing statement that an effect observed in an animal model is not a clinical outcome and does not support a certainty rating.
- Trials are described as terminated where they completed as planned — arising from DRAFT-MELANOTAN-II/004. 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-066/3 · https://compoundevidence.com/comment-periods/draft-melanotan-ii-monograph/disposition/ · retrieved 30 July 2026