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Genmab — Marts 2019

Planlagt Fastgjort Låst Flyttet Genmab
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  • S Offline
    S Offline
    Sukkeralf
    wrote on sidst redigeret af
    #999

    jans answer: The COLUMBA study is the only non inferiority PHIII that would be needed to obtain a label for SC daratumumab...

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    • S Offline
      S Offline
      Sukkeralf
      wrote on sidst redigeret af
      #1000

      In order to obtain a broader label, we would also need to obtain safety data from the PLEIADES study which is evaluating 3 cohorts of patients DARA + RD, DARA + VMP and DARA + VRD. If this study reads out positively, we expect to obtain a broad label for SC DARA..

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      • S Offline
        S Offline
        Sukkeralf
        wrote on sidst redigeret af
        #1001

        To me thats sounds like they will file first on the Columba data............and then later a sBLA on combination data

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        • E Offline
          E Offline
          E_L
          wrote on sidst redigeret af
          #1002

          that is also my best geuss at the moment

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          • BulderB Offline
            BulderB Offline
            Bulder
            wrote on sidst redigeret af
            #1003

            Yes,and with a label limited to R/R MM and not frontline.

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            • S Offline
              S Offline
              Sukkeralf
              wrote on sidst redigeret af
              #1004

              yes and maybe maintenance

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              • D Offline
                D Offline
                Doc4
                wrote on sidst redigeret af
                #1005

                @pensionisten 8:28....FYI Mayzent = Siponimod og er beskrevet her: https://scleroseforeningen.dk/nyheder/gilenya-20. Samme virkning da siponimod er en syntetisk udgave af Gilenya, som har væet på markedet i 7 år. Siponimod har en bedre bivirkningsprofil, da target kun er 2 ud af 5 forskellige SiP molekyler, hvor Gilenya targets 4/5, hvoraf et i hjertet. Held og lykke;)

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                • D Offline
                  D Offline
                  Doc4
                  wrote on sidst redigeret af
                  #1006

                  Hmm...ser ud til links fungere bedst, som afslutning og uden andre karakterer efterfølgende, så her er link der fårhåbentlig fungerer https://scleroseforeningen.dk/nyheder/gilenya-20

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                  • V Offline
                    V Offline
                    Vester
                    wrote on sidst redigeret af
                    #1007

                    The Plaides study has been fully recruited for approx 5 months now.. One could hope that the label expansion happens fast, as they only need safety data, as Jan states..

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                    • A Offline
                      A Offline
                      AaBforever
                      wrote on sidst redigeret af
                      #1008

                      Nå..så skal den lige have en over nakken her sidst på dagen.

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                      • Legolas23L Offline
                        Legolas23L Offline
                        Legolas23
                        wrote on sidst redigeret af
                        #1009

                        Det er meget bredt og ikke specifikt genmab, som falder. Hovedet op og på med de lange briller

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                        • A Offline
                          A Offline
                          AaBforever
                          wrote on sidst redigeret af
                          #1010

                          Vestas stiger..:-)

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                          • Helge_LarsenPI-redaktørH Offline
                            Helge_LarsenPI-redaktørH Offline
                            Helge_LarsenPI-redaktør
                            wrote on sidst redigeret af
                            #1011

                            Just a moment...

                            favicon

                            (www.proinvestor.com)

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                            • BulderB Offline
                              BulderB Offline
                              Bulder
                              wrote on sidst redigeret af
                              #1012

                              FDA Puts Partial Hold on Venetoclax’s Multiple Myeloma Trials https://myelomaresearchnews.com/2019/03/27/fda-partially-stops-venetoclax-clinical-trials-in-multiple-myeloma/?utm_source=Myeloma+List&utm_campaign=5e5e2e74d5-RSS_WEEKLY_EMAIL_CAMPAIGN&utm_medium=email&utm_term=0_14fcd0022a-5e5e2e74d5-72491777

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                              • BulderB Offline
                                BulderB Offline
                                Bulder
                                wrote on sidst redigeret af
                                #1013

                                Dara-Veneto suspenderet https://clinicaltrials.gov/ct2/show/NCT03701321?term=NCT03701321&rank=1

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                                • nohopeN Offline
                                  nohopeN Offline
                                  nohope
                                  wrote on sidst redigeret af
                                  #1014

                                  Har kikket - men ikke fundet nogen begrundelse - noget jeg overser ?

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                                  • BulderB Offline
                                    BulderB Offline
                                    Bulder
                                    wrote on sidst redigeret af
                                    #1015

                                    17:42?

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                                    • nohopeN Offline
                                      nohopeN Offline
                                      nohope
                                      wrote on sidst redigeret af
                                      #1016

                                      17:43

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                                      • BulderB Offline
                                        BulderB Offline
                                        Bulder
                                        wrote on sidst redigeret af
                                        #1017

                                        begrundelsen kan du se 17:42

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                                        • nohopeN Offline
                                          nohopeN Offline
                                          nohope
                                          wrote on sidst redigeret af
                                          #1018
                                          • suspended- kan ikke se andet. Er der en forklaring på hvorfor det er suspenderet ?
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