Public comment period · §3
Draft monograph: Petrelintide — 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-PETRELINTIDE/001 | Dr Matthias Wintringham industry | The document should not describe uses outside the approved indication | Not accepted |
| DRAFT-PETRELINTIDE/002 | Dr Jerome Petrossian | The monograph should state what the compound costs | Not accepted |
| DRAFT-PETRELINTIDE/003 | Dr Melisande Thorsby-Nakamura | The analytical section assumes a reference standard that is not generally available | Accepted |
| DRAFT-PETRELINTIDE/004 | Ms Rhiannon Okoye-Vandergraaf | The document is unreadable without specialist training | Accepted in part |
| DRAFT-PETRELINTIDE/005 | Dr Jozef Brandvold-Achterberg | Trials are described as terminated where they completed as planned | Accepted in part |
| DRAFT-PETRELINTIDE/006 | Dr Oisín Rautavaara | Point estimates are given without an interval | Accepted in part |
| DRAFT-PETRELINTIDE/007 | Dr Lorcan Uttridge | Anti-drug antibody data are omitted | Accepted in part |
| DRAFT-PETRELINTIDE/008 | Dr Evander Whitmarsh-Obi | A purity figure from a certificate is quoted as though it were a content figure | Accepted |
| DRAFT-PETRELINTIDE/009 | Professor Chukwuemeka Rasmussen-Adeyemi | What happens to weight after the compound is stopped is not in the assessed outcomes | Accepted |
| DRAFT-PETRELINTIDE/010 | Dr Zdenka Nyquist-Obiora | The preclinical section is extensive and the clinical section is not | Accepted in part |
| DRAFT-PETRELINTIDE/011 | Ivo Mountstephen | The compound is supplied under names the monograph does not list | Accepted |
| DRAFT-PETRELINTIDE/012 | Dr Lorcan Zaleski-Mbeki | The absence of a rare harm in the trial set is presented as reassurance | Accepted |
| DRAFT-PETRELINTIDE/013 | Dr Vasilisa Immelmann | Regulatory status is stated without naming the jurisdiction | Accepted |
| DRAFT-PETRELINTIDE/014 | Dr Jolanta Uttridge | Storage and reconstitution guidance is given without stating what it rests on | Accepted in part |
| DRAFT-PETRELINTIDE/015 | Georgiana Zimmerthal | Declared interests should appear on the document rather than on a separate page | Noted, no amendment |
| 15 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 | 6 | 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 | 2 | 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
- The analytical section assumes a reference standard that is not generally available — arising from DRAFT-PETRELINTIDE/003. 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 document is unreadable without specialist training — arising from DRAFT-PETRELINTIDE/004. Every document now opens with a plain-language summary of not more than 150 words, placed above the technical abstract and carrying the same certainty language, so that the two cannot diverge.
- Trials are described as terminated where they completed as planned — arising from DRAFT-PETRELINTIDE/005. 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.
- Point estimates are given without an interval — arising from DRAFT-PETRELINTIDE/006. 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.
- Anti-drug antibody data are omitted — arising from DRAFT-PETRELINTIDE/007. 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-PETRELINTIDE/008. 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 to weight after the compound is stopped is not in the assessed outcomes — arising from DRAFT-PETRELINTIDE/009. Post-withdrawal trajectory is now an assessed outcome wherever a withdrawal period was studied, rated on the same scale as the others. Where no withdrawal period was studied the outcome is recorded as not assessed.
- The preclinical section is extensive and the clinical section is not — arising from DRAFT-PETRELINTIDE/010. 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.
- The compound is supplied under names the monograph does not list — arising from DRAFT-PETRELINTIDE/011. The synonym list is extended to include every name the Institute can evidence from a document it holds, each recorded with its source. Names asserted without a supporting document are not added, and the distinction is stated at the head of the list.
- The absence of a rare harm in the trial set is presented as reassurance — arising from DRAFT-PETRELINTIDE/012. 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.
- Regulatory status is stated without naming the jurisdiction — arising from DRAFT-PETRELINTIDE/013. 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.
- Storage and reconstitution guidance is given without stating what it rests on — arising from DRAFT-PETRELINTIDE/014. In-use periods now appear only where supported by a cited stability determination on a stated presentation, and elsewhere the monograph records that no in-use stability evidence was identified for this presentation.
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-070/3 · https://compoundevidence.com/comment-periods/draft-petrelintide-monograph/disposition/ · retrieved 30 July 2026