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Genmab — Maj 2018

Planlagt Fastgjort Låst Flyttet Genmab
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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

          1 Reply Last reply
          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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                • 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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                      0
                      • 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

                                1 Reply Last reply
                                0
                                • SolsenS Offline
                                  SolsenS Offline
                                  Solsen
                                  wrote on sidst redigeret af
                                  #1060

                                  Husk ARD er 1:10

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                                  0
                                  • 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?

                                    1 Reply Last reply
                                    0
                                    • 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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                                        • T Offline
                                          T Offline
                                          Thomas
                                          wrote on sidst redigeret af
                                          #1064

                                          Er det efter reglerne hvis de har indblik i nogle fornuftige data og ikke melder noget ud til markedet?

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                                          0

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