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Januari 2019. De goedkeuring komt eraan in H1-2019 !!!

1.504 Posts
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  1. LBR81 24 januari 2019 17:16
    Vorige keer stond er bij CHMP : Scope: Request by the applicant for an extension to the clock stop to respond to the List of Outstanding Issues adopted on 14.09.2018

    is nu vraag tot SECOND clock stop extension, is dus vraag tot een tweede verlenging van clock stop, geen witte rook dus vlgs mij.
  2. Jake7 24 januari 2019 17:29
    quote:

    LBR81 schreef op 24 januari 2019 17:16:

    Vorige keer stond er bij CHMP : Scope: Request by the applicant for an extension to the clock stop to respond to the List of Outstanding Issues adopted on 14.09.2018

    is nu vraag tot SECOND clock stop extension, is dus vraag tot een tweede verlenging van clock stop, geen witte rook dus vlgs mij.
    Mogelijke witte rook enkel bij:
    Scope: Opinion
    Action: for adoption

    De scope is nu helaas echter anders namelijk
    Scope: request by the applicant for a second clock stop extension

    Blijkbaar heeft Kiadis meer tijd nodig om een nieuwe statistische benadering van de bestaande data voor te leggen...

    Nog extra info:

    On receipt of the responses from the applicant, the clock is re-started (day 121) and the rapporteur and co-rapporteur prepare a joint assessment report of the responses by day 150. Any issue(s) identified are discussed on day 180 during the plenary CHMP meeting and a decision may be made on whether to issue a positive CHMP opinion. If there still are any outstanding or unresolved issues, the clock is stopped again. Applicants normally respond within 1 month but in exceptional circumstances, a further extension of 1 month (or maximum 2 months) may be granted if justified by the applicant and agreed by the CHMP. Day 181 is the re-start of the clock when the response is assessed and an oral explanation may take place. On or before day 210, the CHMP adopts its opinion. The opinion requires a consensus or an absolute majority from its members. The deadline for adopting an opinion and finalization of the CHMP Assessment Report is day 210 of the procedure. A CHMP opinion, whether positive or negative, may be the subject of a re-examination (an appeal), a procedure that has its own time frame. In terms of the assessment phase and the clock stops during CHMP review, these periods averaging 168 days and 118 days, respectively, for all drugs given a positive opinion during 2009–2011 inclusive. The interval between a CHMP opinion to a binding decision by the EC averaged 58 days during the same 3-year period [17].

    www.ncbi.nlm.nih.gov/pmc/articles/PMC...
  3. forum rang 8 BassieNL 24 januari 2019 17:32
    quote:

    Jake7 schreef op 24 januari 2019 17:29:

    [...]

    Mogelijke witte rook enkel bij:
    Scope: Opinion
    Action: for adoption

    De scope is nu helaas echter anders namelijk
    Scope: request by the applicant for a second clock stop extension

    Blijkbaar heeft Kiadis meer tijd nodig om een nieuwe statistische benadering van de bestaande data voor te leggen...

    Ik denk dat je gelijk hebt.
    Dit voelt niet goed.

    'Following the release of the LoOIs at day 180, applicants should respond in writing within
    1-month. Only very limited new data derived from new studies would be acceptable at this
    point of the procedure as assessment time beyond day 180 is extremely limited. In exceptional
    circumstances, a 1-month extension in submission of the written responses may be granted
    only upon provision of appropriate scientific justifications to be reviewed and agreed upon by
    the CHMP.'

    zie pag 4
    www.ema.europa.eu/documents/regulator...
  4. MZ 24 januari 2019 17:33
    Op 12 oktober kwam Kiadis met het PB over de vertraging:
    www.kiadis.com/kiadis-pharma-provides...

    Uit de CHMP minutes van 15-18 oktober 2018:

    3.4.1. viable T-cells - Orphan - ATMP - EMEA/H/C/002397
    Kiadis Pharma Netherlands B.V.; adjunctive treatment in haematopoietic stem cell transplantation (HSCT) for a malignant disease
    Scope: Request by the applicant for an extension to the clock stop to respond to the List of Outstanding Issues adopted on 14.09.2018
    Action: For adoption

    List of Outstanding Issues adopted on 14.09.2018, 25.05.2018. List of Questions adopted on 08.09.2017.

    Op de agenda van CAT van 23-25 januari:

    2.6.1. Viable T-cells - Orphan - EMEA/H/C/002397
    Kiadis Pharma Netherlands B.V.; Adjunctive treatment in haematopoietic stem cell transplantation (HSCT) for a malignant disease
    Scope: request by the applicant for a second clock stop extension .
    Action: for adoption

    Oral Explanation took place on 12.09.2018. List of Outstanding Issues adopted on 14.09.18 and 25.05.2018. List of Questions adopted on 08.09.2017.

    Verdere data
    08.09.2017 List of Questions adopted
    25.05.2018 List of Outstanding Issues adopted
    12.09.2018 Oral explanation
    14.09.2018 List of Outstanding Issues adopted

    Tja, het blijft voor mij een rookgordijn dat hele EMA proces.
1.504 Posts
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