Consultation record
Submissions accepted — page 16
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.
Submissions
735 documents · page 16 of 25
Table 1. Submissions with this disposition, on this page.
| Reference | Consultation | Respondent | Point raised |
|---|---|---|---|
| DRAFT-ORAL-SEMAGLU/003 | Draft monograph: Semaglutide, oral | Dr Jerome Lavrentiev | The absence of paediatric evidence is not stated where a reader would look for it |
| DRAFT-ORAL-SEMAGLU/005 | Draft monograph: Semaglutide, oral | Dr Eamon Immelmann | The analytical section assumes a reference standard that is not generally available |
| DRAFT-ORAL-SEMAGLU/006 | Draft monograph: Semaglutide, oral | Dr Marisol Dunmore-Ekpo | The certainty rating for the principal assessed outcome cannot be traced to the contributing trials |
| DRAFT-ORAL-SEMAGLU/007 | Draft monograph: Semaglutide, oral | Dr Melisande Kirkpatrick-Ola | Open-label extension data are presented alongside randomised data without distinction |
| DRAFT-ORAL-SEMAGLU/008 | Draft monograph: Semaglutide, oral | Dr Evander Whitmarsh-Obi | Quantitative claims are reproduced without the method that produced them |
| DRAFT-PETRELINTIDE/003 | Draft monograph: Petrelintide | Dr Melisande Thorsby-Nakamura | The analytical section assumes a reference standard that is not generally available |
| DRAFT-PETRELINTIDE/008 | Draft monograph: Petrelintide | Dr Evander Whitmarsh-Obi | A purity figure from a certificate is quoted as though it were a content figure |
| DRAFT-PETRELINTIDE/009 | Draft monograph: Petrelintide | Professor Chukwuemeka Rasmussen-Adeyemi | What happens to weight after the compound is stopped is not in the assessed outcomes |
| DRAFT-PETRELINTIDE/011 | Draft monograph: Petrelintide | Ivo Mountstephen | The compound is supplied under names the monograph does not list |
| DRAFT-PETRELINTIDE/012 | Draft monograph: Petrelintide | Dr Lorcan Zaleski-Mbeki | The absence of a rare harm in the trial set is presented as reassurance |
| DRAFT-PETRELINTIDE/013 | Draft monograph: Petrelintide | Dr Vasilisa Immelmann | Regulatory status is stated without naming the jurisdiction |
| DRAFT-PRAMLINTIDE-/001 | Draft monograph: Pramlintide | Dr Marisol Dunmore-Ekpo | Every contributing trial shares one sponsor and the monograph does not say so |
| DRAFT-PRAMLINTIDE-/004 | Draft monograph: Pramlintide | Dr Perpetua Haverkamp-Diallo industry | Two factual descriptions of the sponsor's programme are inaccurate |
| DRAFT-PRAMLINTIDE-/006 | Draft monograph: Pramlintide | Ivo Mountstephen | The search date is not on the face of the document |
| DRAFT-PRAMLINTIDE-/007 | Draft monograph: Pramlintide | Dr Lorcan Zaleski-Mbeki | Local reactions are omitted from the adverse-event table because the trials reported them separately |
| DRAFT-PRAMLINTIDE-/008 | Draft monograph: Pramlintide | Dr Vasilisa Immelmann | Regulatory status is stated without naming the jurisdiction |
| DRAFT-PRAMLINTIDE-/009 | Draft monograph: Pramlintide | Dr Zdenka Nyquist-Obiora | Evidence for one member of the class is presented as evidence for this compound |
| DRAFT-PRAMLINTIDE-/010 | Draft monograph: Pramlintide | Dr Ludmila Brackenridge | What happens when the compound is stopped is not addressed |
| DRAFT-PRAMLINTIDE-/011 | Draft monograph: Pramlintide | Dr Evander Whitmarsh-Obi | The monograph does not tell a reader that two vials of the same compound may not contain the same… |
| DRAFT-PRAMLINTIDE-/015 | Draft monograph: Pramlintide | Dr Abimbola Sotomayor-Ekwueme | The route of administration studied is not the route in which the compound is supplied |
| DRAFT-PT-141-MONOG/002 | Draft monograph: PT-141 (bremelanotide) | Dr Ivo Quintanilha | Effect estimates are given without naming the comparator |
| DRAFT-PT-141-MONOG/003 | Draft monograph: PT-141 (bremelanotide) | Dr Lorcan Zaleski-Mbeki | The absence of a rare harm in the trial set is presented as reassurance |
| DRAFT-PT-141-MONOG/004 | Draft monograph: PT-141 (bremelanotide) | Dr Adaeze Underhill-Okafor | Open-label extension data are presented alongside randomised data without distinction |
| DRAFT-PT-141-MONOG/005 | Draft monograph: PT-141 (bremelanotide) | Dr Eulalia Sonnenberg-Eze | Mechanistic claims for a peptide fragment are carried without evidence that the fragment acts as… |
| DRAFT-PT-141-MONOG/006 | Draft monograph: PT-141 (bremelanotide) | Dr Vasilisa Immelmann | Regulatory status is stated without naming the jurisdiction |
| DRAFT-PT-141-MONOG/007 | Draft monograph: PT-141 (bremelanotide) | Dr Vasilisa Sandringham-Adu | The population to which the headline estimate applies is not stated with the estimate |
| DRAFT-PT-141-MONOG/009 | Draft monograph: PT-141 (bremelanotide) | Dr Ludmila Brackenridge | What happens when the compound is stopped is not addressed |
| DRAFT-PT-141-MONOG/010 | Draft monograph: PT-141 (bremelanotide) | Dr Wolfram Quintanilha industry | Two factual descriptions of the sponsor's programme are inaccurate |
| DRAFT-PT-141-MONOG/014 | Draft monograph: PT-141 (bremelanotide) | Dr Odalys Thorsby-Nakamura | Registered trials that never reported are absent from the monograph |
| DRAFT-PT-141-MONOG/016 | Draft monograph: PT-141 (bremelanotide) | Dr Melisande Thorsby-Nakamura | The monograph does not tell a reader that two vials of the same compound may not contain the same… |
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