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Genmab — September 2019

Planlagt Fastgjort Låst Flyttet Genmab
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Denne tråd er blevet slettet. Kun brugere med emne behandlings privilegier kan se den.
  • B Offline
    B Offline
    bibob
    wrote on sidst redigeret af
    #1526

    Omar Nadeem MD. " Dara sq needs to be approved ASAP. 🙂

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    • BulderB Offline
      BulderB Offline
      Bulder
      wrote on sidst redigeret af
      #1527

      Fandt lige det her: FDA informs the applicant of a Priority Review designation within 60 days of the receipt of the original BLA. - Og det var i tirsdags. Har skrevet og spurgt Andrew Carlsen om de overhovedet har søgt. https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/priority-review

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      • BulderB Offline
        BulderB Offline
        Bulder
        wrote on sidst redigeret af
        #1528

        ... om sc dara altså

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        • E Offline
          E Offline
          E_L
          wrote on sidst redigeret af
          #1529

          New DARZALEX® (daratumumab) Data from GRIFFIN Study Show High Response Rate and Depth of Response in Patients with Newly Diagnosed Multiple Myeloma Who are Transplant-Eligible https://www.prnewswire.com/news-releases/new-darzalex-daratumumab-data-from-griffin-study-show-high-response-rate-and-depth-of-response-in-patients-with-newly-diagnosed-multiple-myeloma-who-are-transplant-eligible-300918272.html

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          • E Offline
            E Offline
            E_L
            wrote on sidst redigeret af
            #1530

            looks like very good data.to me

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            • E Offline
              E Offline
              E_L
              wrote on sidst redigeret af
              #1531

              it also mentions PLEIADES data has been included in the submission of the SC BLA to the FDA

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              • E Offline
                E Offline
                E_L
                wrote on sidst redigeret af
                #1532

                https://twitter.com/notthatjensmith/status/1172894272238104578

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                • E Offline
                  E Offline
                  E_L
                  wrote on sidst redigeret af
                  #1533

                  https://twitter.com/theMMRF/status/1173218606643142656

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                  • E Offline
                    E Offline
                    E_L
                    wrote on sidst redigeret af
                    #1534

                    https://twitter.com/MM_Hub/status/1172866987040677888

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                    • BulderB Offline
                      BulderB Offline
                      Bulder
                      wrote on sidst redigeret af
                      #1535

                      Most impressing is the doubling of MRDneg in Griffin.

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                      • BulderB Offline
                        BulderB Offline
                        Bulder
                        wrote on sidst redigeret af
                        #1536

                        ... more than doubling it is

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                        • P Offline
                          P Offline
                          peter12
                          wrote on sidst redigeret af
                          #1537

                          Lidt bedre end fra Ph1 https://www.targetedonc.com/investigator-perspectives/frontline-mm/the-griffin-trial-in-multiple-myeloma

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                          0
                          • B Offline
                            B Offline
                            bibob
                            wrote on sidst redigeret af
                            #1538

                            Dara kan stort set ikke undgå at blive en del af frontline i alle kombi som de parres med. Alt bliver bedre. " vil De have det bedste udkomme. - bare tilsæt Dara. " 😄

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                            • SolsenS Offline
                              SolsenS Offline
                              Solsen
                              wrote on sidst redigeret af
                              #1539

                              Det har været nogle gode dage at være Genmab aktionær. Kursen skal nok afspejle fremgangene på et tidspunkt.

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                              • BulderB Offline
                                BulderB Offline
                                Bulder
                                wrote on sidst redigeret af
                                #1540

                                Nu er spørgsmålet så om Griffin kommer på compendia listing og dermed kan bruges off label. Der går en rum tid før der ligger Perseus data, der kan files på.

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                                • SolsenS Offline
                                  SolsenS Offline
                                  Solsen
                                  wrote on sidst redigeret af
                                  #1541

                                  Er det ikke mærkeligt at fastsætte et endpoint og statistisk metode til at vurdere forsøget på, hvis ikke der er en ide med det.

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                                  • BulderB Offline
                                    BulderB Offline
                                    Bulder
                                    wrote on sidst redigeret af
                                    #1542

                                    De 41% der fik IRR i Griffin, får vi næste gang beydeligt lavere, da både Perseus og Cepheus kører med sc dara.

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                                    • BulderB Offline
                                      BulderB Offline
                                      Bulder
                                      wrote on sidst redigeret af
                                      #1543

                                      Hvad mener du solsen?

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                                      • SolsenS Offline
                                        SolsenS Offline
                                        Solsen
                                        wrote on sidst redigeret af
                                        #1544

                                        Man omtaler at man har aftalt den statistiske metode for at se om forsøget er i mål på endpoint. Det var jo unødvendigt ved et alm fase 2 der blot skulle danne grundlag for et fase 3 forsøg.

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                                        • SolsenS Offline
                                          SolsenS Offline
                                          Solsen
                                          wrote on sidst redigeret af
                                          #1545

                                          JW mente vel også at kombinatiome kom i compendia listing. Eller husker jeg forkert.

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