Public comment period · §3
Draft monograph: TB-500 — 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-TB-500-MONOG/002 | Dr Lorcan Whitmarsh-Obi | The absence of a rare harm in the trial set is presented as reassurance | Accepted |
| DRAFT-TB-500-MONOG/003 | Dr Ilona Mbatha-Fredriksen industry | The monograph should reproduce the approved labelling rather than paraphrase it | Accepted in part |
| DRAFT-TB-500-MONOG/004 | Dr Leonhard Quenneville | The pharmacokinetic section does not connect half-life to the dosing schedule | Accepted |
| DRAFT-TB-500-MONOG/005 | Dr Stellan Cholmondeley-Ade | Trials are described as terminated where they completed as planned | Accepted in part |
| DRAFT-TB-500-MONOG/007 | Ms Rhiannon Okoye-Vandergraaf industry | Two factual descriptions of the sponsor's programme are inaccurate | Accepted |
| DRAFT-TB-500-MONOG/006 | Xiomara Fairweather-Duru | A superseded version should remain reachable from the version that replaced it | Noted, no amendment |
| DRAFT-TB-500-MONOG/001 | Dr Kolawole Isaksen-Balogun | The monograph does not tell a reader that a stated mass may be substantially counter-ion and water | Accepted |
| DRAFT-TB-500-MONOG/008 | Dr Fenella Steenkamp-Ferreira | Effect estimates are given without naming the comparator | 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 | 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
- The absence of a rare harm in the trial set is presented as reassurance — arising from DRAFT-TB-500-MONOG/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.
- The monograph should reproduce the approved labelling rather than paraphrase it — arising from DRAFT-TB-500-MONOG/003. The approved indication and contraindications are now reproduced verbatim from the named authorisation with its version and date, and the posology section reports the labelled schedule and the schedules studied side by side, with the source of each stated.
- The pharmacokinetic section does not connect half-life to the dosing schedule — arising from DRAFT-TB-500-MONOG/004. The pharmacokinetic section now states approximate time to steady state alongside the half-life and dosing interval, with the assumption of first-order elimination stated, and records where the assumption is not supported for this compound.
- Trials are described as terminated where they completed as planned — arising from DRAFT-TB-500-MONOG/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.
- Two factual descriptions of the sponsor's programme are inaccurate — arising from DRAFT-TB-500-MONOG/007. 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…
- The monograph does not tell a reader that a stated mass may be substantially counter-ion and water — arising from DRAFT-TB-500-MONOG/001. 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.
- Effect estimates are given without naming the comparator — arising from DRAFT-TB-500-MONOG/008. The comparator is now stated in every outcome row, and estimates against different comparators are reported in separate tables with the comparator named in the table caption.
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-078/3 · https://compoundevidence.com/comment-periods/draft-tb-500-monograph/disposition/ · retrieved 30 July 2026