Consultation record

Submissions accepted in part — page 7

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.

Submissions

377 documents · page 7 of 13

Table 1. Submissions with this disposition, on this page.

Reference	Consultation	Respondent	Point raised
DRAFT-IGF-1-LR3-MO/003	Draft monograph: IGF-1 LR3	Dr Mordecai Glendinning-Uche	Anti-drug antibody data are omitted
DRAFT-IGF-1-LR3-MO/004	Draft monograph: IGF-1 LR3	Dr Vittoria Ylönen	The preclinical section is extensive and the clinical section is not
DRAFT-IPAMORELIN-M/001	Draft monograph: Ipamorelin	Dr Eamon Sandringham-Adu	Point estimates are given without an interval
DRAFT-IPAMORELIN-M/004	Draft monograph: Ipamorelin	Brigitta Grünbaum-Sowande	The preclinical section is extensive and the clinical section is not
DRAFT-IPAMORELIN-M/005	Draft monograph: Ipamorelin	Dr Ulysses Bellingham-Ojo	The recorded evidence gaps omit outcomes a reader would consider material
DRAFT-KISSPEPTIN-1/004	Draft monograph: Kisspeptin-10	Dr Fenella Steenkamp-Ferreira	Trials are described as terminated where they completed as planned
DRAFT-KPV-MONOGRAP/003	Draft monograph: KPV	Dr Jozef Brandvold-Achterberg	The analytical section is longer than the clinical assessment it accompanies
DRAFT-KPV-MONOGRAP/012	Draft monograph: KPV	Ignatius Erlingsson	Trials are described as terminated where they completed as planned
DRAFT-KPV-MONOGRAP/008	Draft monograph: KPV	Dr Jerome Lavrentiev	The recorded evidence gaps omit outcomes a reader would consider material
DRAFT-KPV-MONOGRAP/014	Draft monograph: KPV	Dr Rurik Haverkamp-Diallo	References should carry a persistent identifier for every cited source
DRAFT-LARAZOTIDE-M/003	Draft monograph: Larazotide acetate	Leonhard Achterberg	The analytical section is longer than the clinical assessment it accompanies
DRAFT-LIRAGLUTIDE-/005	Draft monograph: Liraglutide	Dr Gervase Crickhowell	Storage and reconstitution guidance is given without stating what it rests on
DRAFT-LIRAGLUTIDE-/008	Draft monograph: Liraglutide	Dr Liesbeth Delacroix-Njoku	Trials are described as terminated where they completed as planned
DRAFT-LIXISENATIDE/007	Draft monograph: Lixisenatide	Nkechi Larsson-Ekwueme	The analytical section is longer than the clinical assessment it accompanies
DRAFT-LIXISENATIDE/004	Draft monograph: Lixisenatide	Dr Stellan Cholmondeley-Ade	Point estimates are given without an interval
DRAFT-LIXISENATIDE/001	Draft monograph: Lixisenatide	Leonhard Achterberg	Storage and reconstitution guidance is given without stating what it rests on
DRAFT-LL-37-MONOGR/001	Draft monograph: LL-37	Dr Matthias Whitmarsh-Obi	Trials are described as terminated where they completed as planned
DRAFT-MARIDEBART-C/001	Draft monograph: Maridebart cafraglutide	Dr Prosper Vercingetorix	Trials are described as terminated where they completed as planned
DRAFT-MAZDUTIDE-MO/002	Draft monograph: Mazdutide	Dr Yaa Kettlewell	Anti-drug antibody data are omitted
DRAFT-MELANOTAN-II/004	Draft monograph: Melanotan-II	Dr Leonhard Quenneville	Trials are described as terminated where they completed as planned
DRAFT-ORAL-SEMAGLU/003	Draft monograph: Semaglutide, oral	Dr Lorcan Whitmarsh-Obi	Where the compound is a glucagon-like peptide-1 receptor agonist, the cardiovascular outcome…
DRAFT-ORAL-SEMAGLU/007	Draft monograph: Semaglutide, oral	Xiomara Fairweather-Duru	Trials are described as terminated where they completed as planned
DRAFT-PETRELINTIDE/009	Draft monograph: Petrelintide	Dr Sigrún Lavrentiev	Trials are described as terminated where they completed as planned
DRAFT-PETRELINTIDE/001	Draft monograph: Petrelintide	Dr Wolfram Kaltenbach-Mensah	The analytical section is longer than the clinical assessment it accompanies
DRAFT-PETRELINTIDE/006	Draft monograph: Petrelintide	Dr Katarzyna Yorkstone	Point estimates are given without an interval
DRAFT-PETRELINTIDE/008	Draft monograph: Petrelintide	Yusuf Whitmarsh-Obi industry	The monograph should reproduce the approved labelling rather than paraphrase it
DRAFT-PETRELINTIDE/013	Draft monograph: Petrelintide	Dr Frideswide Grünbaum-Sowande	The recorded evidence gaps omit outcomes a reader would consider material
DRAFT-PETRELINTIDE/007	Draft monograph: Petrelintide	Dr Amara Quaresma	The preclinical section is extensive and the clinical section is not
DRAFT-PETRELINTIDE/005	Draft monograph: Petrelintide	Dr Lorcan Zaleski-Mbeki	The document is unreadable without specialist training
DRAFT-PRAMLINTIDE-/008	Draft monograph: Pramlintide	Ms Rhiannon Okoye-Vandergraaf	Point estimates are given without an interval

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