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    AB SCIENCE : Très intéressant vu sur groupe faceb. AB

    26 janv. 2024 23:12

    Bonjour, On est tous déçu par l’annonce du jour, néanmoins ne cédons pas à la panique, j’ai repris les rapports CHMP de mars 2022 a février 2023 et j’ai retrouvé 12 médicaments étant dans la rubrique 2.1 pour une oral explanation mais au final ne participant pas a une Oral explanation pour je cite « The CHMP agreed that an oral explanation was not needed at this time » mais au final se retrouvant avec une nouvelle liste de questions supplémentaires, sur ces 12 medicaments, 11 obtiennent une autorisation principalement dans les 3,4 mois qui suivent, 1 ne l’obtient pas, motif de refus : « pas d’etude randomisé » ce qui n’est pas le cas pour AB …

    Donc, oui on attend, oui les délais sont longs, mais rappelons-nous que c’est pour mettre en vente une nouvelle molécules, via une entreprise qui n’est pas encore une pharmacie.


    Ci-dessous le détail de mes recherches, source : minutes des CHMP,
    Nom du médicament ou molécule
    Premier paragraphe : rubrique 2.1
    Deuxième paragraphe : rubrique 3.2 pour le même médicament
    Décisions du CHMP



    CHMP MAR 2022

    Budesonide

    Action: Oral explanation to be held on 23 March 2022 at 11:00
    List of Outstanding Issues adopted on 27.01.2022. List of Questions adopted on 14.09.2021.
    The CHMP agreed that an oral explanation was not needed at this time.
    See 3.2

    List of Outstanding Issues adopted on 27.01.2022. List of Questions adopted on 14.09.2021.
    The Committee was reminded of the status of this application and its remaining outstanding issues.
    See 2.1
    The CHMP agreed that an oral explanation was not needed at this time.
    The Committee adopted a 2nd list of outstanding issues with a specific timetable.

    Opinion adopted
    19/05/2022
    Marketing authorisation issued
    15/07/2022


    CHMP MAY 2022

    melphalan flufenamide

    Action: Possible oral explanation to be held on 17 May 2022 at 14:00
    List of Outstanding Issues adopted on 24.03.2022. List of Questions adopted on 16.09.2021.
    The CHMP agreed that an oral explanation was not needed at this time.
    See 3.2

    List of Outstanding Issues adopted on 24.03.2022. List of Questions adopted on 16.09.2021.
    See 2.1
    The Committee was reminded of the status of this application and its remaining outstanding issues.
    The CHMP agreed that an oral explanation was not needed at this time.
    The Committee adopted a 2nd list of outstanding issues with a specific timetable.

    Marketing authorisation issued
    17/08/2022

    Tezepelumab

    Action: Possible oral explanation to be held on 17 May 2022 at 16:00
    List of Outstanding Issues adopted on 24.03.2022. List of Questions adopted on 14.10.2021.
    The CHMP agreed that an oral explanation was not needed at this time.
    See 3.2


    List of Outstanding Issues adopted on 24.03.2022. List of Questions adopted on 14.10.2021.
    See 2.1
    The Committee was reminded of the status of this application and its remaining outstanding issues.
    The CHMP agreed that an oral explanation was not needed at this time.
    The Committee adopted a 2nd list of outstanding issues with a specific timetable.

    Marketing authorisation issued
    19/09/2022


    CHMP JUN 2022

    Maribavir

    Action: Oral explanation to be held on 21 June 2022 at 14:00
    List of Outstanding Issues adopted on 22.04.2022. List of Questions adopted on 14.10.2021.
    An oral explanation was held on 21 June 2022. The presentation by the applicant focused on the clinical data in support of the application.
    See 3.2


    List of Outstanding Issues adopted on 22.04.2022. List of Questions adopted on 14.10.2021.
    See 2.1
    The CHMP agreed that an oral explanation was not needed at this time.
    The Committee was reminded of the status of this application and its remaining outstanding issues.
    The Committee adopted a 2nd list of outstanding issues with a specific timetable.

    Marketing authorisation issued
    09/11/2022

    Fosdenopterin

    Action: Oral explanation to be held on 22 June 2022 at 15:30
    List of Outstanding Issues adopted on 20.04.2022. List of Questions adopted on 22.02.2022.
    The CHMP agreed that an oral explanation was not needed at this time.
    See 3.2

    List of Outstanding Issues adopted on 20.04.2022. List of Questions adopted on 22.02.2022.
    See 2.1
    The CHMP agreed that an oral explanation was not needed at this time.
    The Committee was reminded of the status of this application and its remaining outstanding issues.
    The Committee adopted a 2nd list of outstanding issues with a specific timetable.

    Marketing authorisation issued
    15/09/2022


    CHMP JUL 2022
    Mitapivat

    Action: Oral explanation to be held on 20 July 2022 at 17:00
    List of Outstanding Issues adopted on 19.05.2022, 24.03.2022. List of Questions adopted on 11.11.2021.
    The CHMP agreed that an oral explanation was not needed at this time.
    See 3.2

    List of Outstanding Issues adopted on 19.05.2022, 24.03.2022. List of Questions adopted on 11.11.2021.
    See 2.1
    The CHMP agreed that an oral explanation was not needed at this time.
    The Committee was reminded of the status of this application and its remaining outstanding issues. The Committee adopted a 3rd list of outstanding issues with a specific timetable.
    The CHMP agreed on the need to consult the non-clinical working party (NcWP) and adopted a list of questions to this group.

    Marketing authorisation issued
    09/11/2022


    CHMP SEPT 2022

    Spesolimab

    Action: Oral explanation to be held on 14 September 2022 at 14:00
    List of Outstanding Issues adopted on 21.07.2022. List of Questions adopted on 24.02.2022.
    The CHMP agreed that an oral explanation was not needed at this time.
    See 3.2

    List of Outstanding Issues adopted on 21.07.2022. List of Questions adopted on 24.02.2022.
    See 2.1
    The CHMP agreed that an oral explanation was not needed at this time.
    The Committee was reminded of the status of this application and its remaining outstanding issues.
    The Committee adopted a 2nd list of outstanding issues with a specific timetable.

    Marketing authorisation issued
    09/12/2022

    CHMP OCT 2022

    iodine (131I) omburtamab

    Action: Possible oral explanation to be held on 11 October 2022 at 14:00
    List of Outstanding Issues adopted on 23.06.2022. List of Questions adopted on 16.09.2021.
    The CHMP agreed that an oral explanation was not needed at this time.
    See 3.2
    List of Outstanding Issues adopted on 23.06.2022. List of Questions adopted on 16.09.2021.
    See 2.1
    The CHMP agreed that an oral explanation was not needed at this time.
    The Committee was reminded of the status of this application and its remaining outstanding issues.
    The Committee adopted a 2nd list of outstanding issues with a specific timetable.


    Refusal of marketing authorisation
    12/04/2023

    As the main study did not have a randomised comparator, it was not possible to determine a treatment effect.

    CHMP NOV 2022

    Miglustat

    List of Outstanding Issues adopted on 15.09.2022. List of Questions adopted on 24.03.2022.
    The CHMP agreed that an oral explanation was not needed at this time.
    See 3.2
    List of Outstanding Issues adopted on 15.09.2022. List of Questions adopted on 24.03.2022.
    The Committee was reminded of the status of this application and its remaining outstanding issues.
    The CHMP agreed that an oral explanation was not needed at this time.
    See 2.1
    The Committee adopted a 2nd list of outstanding issues with a specific timetable.

    Marketing authorisation issued
    26/06/2023

    Cipaglucosidase

    Action: Oral explanation to be held on 09 November 2022 at 09:00
    List of Outstanding Issues adopted on 15.09.2022. List of Questions adopted on 24.03.2022.
    The CHMP agreed that an oral explanation was not needed at this time.
    See 3.2

    List of Outstanding Issues adopted on 15.09.2022. List of Questions adopted on 24.03.2022.
    The Committee was reminded of the status of this application and its remaining outstanding issues.
    The CHMP agreed that an oral explanation was not needed at this time.
    See 2.1
    The Committee adopted a 2nd list of outstanding issues with a specific timetable.

    Marketing authorisation issued
    20/03/2023

    CHMP DEC 2022

    -

    CHMP JANV 2023

    Pegunigalsidase

    Action: Oral explanation to be held on Tuesday 24 January 2023 at 09:00
    List of Outstanding Issues adopted on 10.11.2022. List of Questions adopted on 23.06.2022.
    The CHMP agreed that an oral explanation was not needed at this time.
    See 3.2

    List of Outstanding Issues adopted on 10.11.2022. List of Questions adopted on 23.06.2022.
    See 2.1
    The Committee was reminded of the status of this application and its remaining outstanding issues.
    The CHMP agreed that an oral explanation was not needed at this time.
    The Committee adopted a 2nd list of outstanding issues with a specific timetable.

    Marketing authorisation issued
    04/05/2023


    CHMP FEV 2023


    Camzyos

    Action: Oral explanation to be held on 22 February 2023 at 16:00
    List of Outstanding Issues adopted on 15.12.2022, 21.07.2022. List of Questions adopted on 27.01.2022.
    The CHMP agreed that an oral explanation was not needed at this time.
    See 3.2

    List of Outstanding Issues adopted on 15.12.2022, 21.07.2022. List of Questions adopted on 27.01.2022.
    See 2.1
    The CHMP agreed that an oral explanation was not needed at this time.
    The Committee was reminded of the status of this application and its remaining outstanding issues.
    The Committee adopted a 3rd list of outstanding issues with a specific timetable.

    Marketing authorisation issued
    26/06/2023

    9 réponses

    • 26 janvier 2024 23:31

      Quel est le point de vue de RASTVB ?

    • 26 janvier 2024 23:42

      UN AUTRE RAPPEL IMPORTANT : le CHMP pose des questions au J120 et des OUSTANDING ISSUES au J180 et plus, que ce soit des OUSTANDING ISSUES n'est pas en soit péjoratif, c'est juste le terme pour des questions supplementaires. Pas eu encore le point de vue de Rastvb cordialement

    • 26 janvier 2024 23:43

      Merci à l'auteur pour cette recherche et la production de ces statistiques et à toi pour l'avoir relayé sur le forum. C'est encourageant mais ça veut pas dire pour autant que l'AMM est dans la poche.

      Chaque dossier est unique et il serait hasardeux d'anticiper le résultat d'un dossier en s'appuyant sur ceux des autres.

    • 27 janvier 2024 06:44

      M3037443 Bravo pour le boulot et merci pour le partage

    • 27 janvier 2024 07:51

      L'EMA a interet d'accepter le médicament, en raison des données scientifiques que l'on connaît tous.

      Elle ne peut se permettre de mettre en echec cette demande au vu des résultats incroyables
      AB qui veut sa première AMM avec des moyens tout de meme plus limité qu'une big phrama comparativement.

      La bienveillance de l'EMA est son accompagnement a travers cette main tendue.

      Les administrations n'aime pas se donner du travail inutile, si ils PROPOSENT un delai c'est dans l'optique d'accepter. Le cas échéant ils aurraient émis un refus au plus tot!

    • 27 janvier 2024 09:15

      même constat dans les minutes des CHMP suivant jusqu'à a juillet 2023 !!

    • 27 janvier 2024 09:25

      Excellent travail

    • 27 janvier 2024 10:02

      Le pire en bourse c'est de tomber amoureux d'une valeur et de s'y accrocher a tout prix.

    • 28 janvier 2024 21:53

      merci encore

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