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/001 | Dr Zdenka Nyquist-Obiora | The document should state what a reader ought to do | Not accepted |
| DRAFT-TB-500-MONOG/002 | Dr Frideswide Grünbaum-Sowande | The absence of paediatric evidence is not stated where a reader would look for it | Accepted |
| DRAFT-TB-500-MONOG/003 | Dr Wolfram Quintanilha industry | The document should not describe uses outside the approved indication | Not accepted |
| DRAFT-TB-500-MONOG/004 | Dr Fenella Steenkamp-Ferreira | The interaction section lists mechanisms rather than interactions | Accepted in part |
| DRAFT-TB-500-MONOG/005 | Dr Odalys Thorsby-Nakamura | Open-label extension data are presented alongside randomised data without distinction | Accepted |
| DRAFT-TB-500-MONOG/006 | Dr Mordecai Bellingham-Ojo | Mechanistic claims for a peptide fragment are carried without evidence that the fragment acts as described | Accepted |
| DRAFT-TB-500-MONOG/007 | Quentin Whitmarsh-Obi | The compound is supplied under names the monograph does not list | Accepted |
| DRAFT-TB-500-MONOG/008 | Dr Vittoria Quintanilha | Absence of evidence is presented in a form a reader will take as negative evidence | 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 | 1 | 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 | 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 absence of paediatric evidence is not stated where a reader would look for it — arising from DRAFT-TB-500-MONOG/002. The population table now carries a paediatric row in every monograph, and where evidence exists the trials are named.
- The interaction section lists mechanisms rather than interactions — arising from DRAFT-TB-500-MONOG/004. The interaction section is now divided into interactions reported in clinical use and interactions predicted from mechanism, with the second labelled as prediction. Where neither exists the section says so in one line rather than being padded.
- Open-label extension data are presented alongside randomised data without distinction — arising from DRAFT-TB-500-MONOG/005. Extension data now appear in a separate table headed as uncontrolled follow-up, with a standing note on differential withdrawal.
- Mechanistic claims for a peptide fragment are carried without evidence that the fragment acts as… — arising from DRAFT-TB-500-MONOG/006. Mechanistic claims not traceable to a primary source are removed, and those retained carry their source and a statement of whether the underlying work was conducted in vitro, in animals or in humans.
- The compound is supplied under names the monograph does not list — arising from DRAFT-TB-500-MONOG/007. 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.
- Absence of evidence is presented in a form a reader will take as negative evidence — arising from DRAFT-TB-500-MONOG/008. A standing formulation has been adopted and is applied wherever an evidence gap is recorded, distinguishing an outcome assessed and not demonstrated from an outcome not assessed. The formulation is identical at every occurrence so that it can be recognised at…
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