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Genmab — Maj 2018

Planlagt Fastgjort Låst Flyttet Genmab
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Denne tråd er blevet slettet. Kun brugere med emne behandlings privilegier kan se den.
  • 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

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                                • 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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                                      • E Offline
                                        E Offline
                                        E_L
                                        wrote on sidst redigeret af
                                        #1062

                                        trading slightly higher as Danish close anyways

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                                        • SolsenS Offline
                                          SolsenS Offline
                                          Solsen
                                          wrote on sidst redigeret af
                                          #1063

                                          Winkel har givet udtryk for, at man har indblik i data og nu diskuterer, hvilke og hvornår data frigives. Samtidig ser vi udvidelse med 30 pts til i alt 120 pts ligeligt fordelt på to arme i forsøget. Jeg synes det lugter af pivotal trial !

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