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Genmab — Marts 2019

Planlagt Fastgjort Låst Flyttet Genmab
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  • E Offline
    E Offline
    E_L
    wrote on sidst redigeret af
    #992

    they are on a roll!

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    • S Offline
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      Sukkeralf
      wrote on sidst redigeret af
      #993

      Nu nærmer ASCO sig snart - ikke at det bliver den vigtigste konference for Genmab, men om ikke andet kommer der vel opdateringer på diverse dara-studier. Abstract deadlines:

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      • S Offline
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        Sukkeralf
        wrote on sidst redigeret af
        #994

        ASCO Meetings

        ASCO Meetings Program Guide

        favicon

        (meetings.asco.org)

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        • S Offline
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          Sukkeralf
          wrote on sidst redigeret af
          #995

          Nice E L - did we get 100% sure on filing for sc dosing. Was the Columba data enough or.......?

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          • E Offline
            E Offline
            E_L
            wrote on sidst redigeret af
            #996

            that's the million dollar question @Sukkeralf … well more like billion dollar question in this case lol

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            • S Offline
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              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
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                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
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                  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
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                    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
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                      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
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                            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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                                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
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                                  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
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                                    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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