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Genmab — Maj 2018

Planlagt Fastgjort Låst Flyttet Genmab
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  • SolsenS Offline
    SolsenS Offline
    Solsen
    wrote on sidst redigeret af
    #1042

    Mindre godt hvis vi skal afvente data endnu længere ud i fremtiden. Håber bms da
    kunne levere data

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    • BulderB Offline
      BulderB Offline
      Bulder
      wrote on sidst redigeret af
      #1043

      Jeg tror kun SC er med de 6 pts der er nævnt. Hvis det var alle, skulle de have indgået i en særlig fase 2 cohorte. Og der er ikke nævnt. Så jeg tror stadig at de 30 af de nye 36 er IV.

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      • BulderB Offline
        BulderB Offline
        Bulder
        wrote on sidst redigeret af
        #1044

        Muligvis er der en chance for - som E L foreslår - at de alligevel kan meddele data på de oprindelige pts i fase 2-delen snart, men at vi må vente til næste år på at få data på de 30 nye.

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        • BulderB Offline
          BulderB Offline
          Bulder
          wrote on sidst redigeret af
          #1045

          Og efter at have tænkt over det over middagen: De ville aldrig have startet en helt ny SC-cohorte, hvis de ikke troede på fremtiden. Derfor tror jeg at den lille sikkerhedsudbygning med SC cohorten skal ses som en forberedelse til det fremtidige - ikke fase 2, men fase 3 studie.

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          • SolsenS Offline
            SolsenS Offline
            Solsen
            wrote on sidst redigeret af
            #1046

            Det har du sikkert ret i Bulder. Jeg var lidt for hurtig. Spændingen og forventningen er ikke blevet mindre !

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            • K Offline
              K Offline
              KWC
              wrote on sidst redigeret af
              #1047

              Ved ikke om det er relevant i forhold til Genmab.. https://www.fiercepharma.com/pharma/merck-s-keytruda-roche-s-tecentriq-may-be-hurting-some-patients-survival-fda

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              • K Offline
                K Offline
                KWC
                wrote on sidst redigeret af
                #1048

                Merck's Keytruda, Roche's Tecentriq may lag chemo in some cancer patients, FDA says

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                • BulderB Offline
                  BulderB Offline
                  Bulder
                  wrote on sidst redigeret af
                  #1049

                  Vi havde det oppe d. 19/5 om fomiddagen

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                  • SolsenS Offline
                    SolsenS Offline
                    Solsen
                    wrote on sidst redigeret af
                    #1050

                    Mon ikke man kunne søge godkendelse på 120 pts forudsat signifikans ?

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                    • E Offline
                      E Offline
                      E_L
                      wrote on sidst redigeret af
                      #1051

                      Agree with Bulder and therefore believe the message is overall positive. Also, preparing for SC is very important.

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                      • E Offline
                        E Offline
                        E_L
                        wrote on sidst redigeret af
                        #1052

                        It would be interesting to know now if the trial was already delayed REGARDLESS of the extra 30 patients. If not, we need to know why Janssen think 30 extra is worth delaying results by 7 months (Would a phase 3 require more patients?)

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                        • E Offline
                          E Offline
                          E_L
                          wrote on sidst redigeret af
                          #1053

                          However, we have to realise, early public phase 2 results are mainly of interest for us; Janssen will have full insight anyway. If they can tweak this phase 2 a bit to kick start phase 3 as Bulder suggests they may even speed up the approval.

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                          • E Offline
                            E Offline
                            E_L
                            wrote on sidst redigeret af
                            #1054

                            These guys are not stupid, I am sure there is a good reason.

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                            • BulderB Offline
                              BulderB Offline
                              Bulder
                              wrote on sidst redigeret af
                              #1055

                              Solsen, teoretisk kunne man vel godt søge godkendelse med 120 pts, hvis data er tilstrækkeligt gode. Men det ville i så fald blive en betinget godkendelse (ligesom dara-pom-dex), hvor der under alle omstædigheder skal et fase 3 studie til.

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                              • BulderB Offline
                                BulderB Offline
                                Bulder
                                wrote on sidst redigeret af
                                #1056

                                E L we don't know if preliminary data regarding the 96 pts will be delayed. But as Winkel said at CC, the level of details is uncertain.

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                                • BulderB Offline
                                  BulderB Offline
                                  Bulder
                                  wrote on sidst redigeret af
                                  #1057

                                  Nevertheless I am much more confident now than before, given the fact that Janssen is expanding the whole study. They wouldn't expand a dead cat. Smells bad. This expansion is almost as good as a read out. Surely we cannot know how good data are, but they are good enough to a continuation.

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                                  • E Offline
                                    E Offline
                                    E_L
                                    wrote on sidst redigeret af
                                    #1058

                                    fully agree

                                    1 Reply Last reply
                                    0
                                    • BulderB Offline
                                      BulderB Offline
                                      Bulder
                                      wrote on sidst redigeret af
                                      #1059

                                      Omsætningen af GMXAY er usædvanligt høj, 113k

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                                      • SolsenS Offline
                                        SolsenS Offline
                                        Solsen
                                        wrote on sidst redigeret af
                                        #1060

                                        Husk ARD er 1:10

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                                        • BulderB Offline
                                          BulderB Offline
                                          Bulder
                                          wrote on sidst redigeret af
                                          #1061

                                          Jo, men der er vel heller ikke udstedt så mange som der er aktier?

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                                          0

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