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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
    #997

    Bulders question: Can data from the Columba study be the basis for approval in all treatment lines in MM, or do we have to await the sc combo study MMY2040?

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    • B Offline
      B Offline
      bibob
      wrote on sidst redigeret af
      #998

      https://ir.genmab.com/news-releases/news-release-details/genmab-announces-european-regulatory-submission-daratumumab-3

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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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