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Genmab — Maj 2018

Planlagt Fastgjort Låst Flyttet Genmab
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  • N Offline
    N Offline
    Nickstar
    wrote on sidst redigeret af
    #1040

    Schiff: det samme mønster som det har været meget længe, aktien viser ingen styrke i mine øjne. Ka ik holde sig ovenvande.

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    • SolsenS Offline
      SolsenS Offline
      Solsen
      wrote on sidst redigeret af
      #1041

      Det ændrede forsøg er vel med 36 nye pts med sc dara, hvoraf de 6 indkøres som safety. Vel godt at man kører dara sc i stilling til ph2 !

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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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                    0
                    • 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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                          0
                          • 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

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                                        0
                                        • BulderB Offline
                                          BulderB Offline
                                          Bulder
                                          wrote on sidst redigeret af
                                          #1059

                                          Omsætningen af GMXAY er usædvanligt høj, 113k

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