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Genmab — August 2015

Planlagt Fastgjort Låst Flyttet Genmab
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Denne tråd er blevet slettet. Kun brugere med emne behandlings privilegier kan se den.
  • G Offline
    G Offline
    gentogen
    wrote on sidst redigeret af
    #1419

    Ja, det er noget andet: For purposes of accelerated approval, a surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign, or other measure, that is thought to predict clinical benefit, but is not itself a measure of clinical benefit.

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    • Helge_LarsenPI-redaktørH Offline
      Helge_LarsenPI-redaktørH Offline
      Helge_LarsenPI-redaktør
      wrote on sidst redigeret af
      #1420

      Tak gutter.:-)

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      0
      • S Offline
        S Offline
        Sukkeralf
        wrote on sidst redigeret af
        #1421

        Responsrater (ORR) er et surrogat endpoint - og BTD har vel nærmest pr automatik indbygget fast track og accelerated approval.

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        0
        • BulderB Offline
          BulderB Offline
          Bulder
          wrote on sidst redigeret af
          #1422

          Var det ikke dig der forleden skrev at FDA normalt/altid bruger alle 60 dage til at beslutte om PR?

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          0
          • S Offline
            S Offline
            Sukkeralf
            wrote on sidst redigeret af
            #1423

            Sådan husker jeg de få eksempler man har fuldt på nært hold

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            0
            • G Offline
              G Offline
              gentogen
              wrote on sidst redigeret af
              #1424

              Ja. Ibrutinib er er vist en af ret få undtagelser, hvor det gik lidt hurtigere

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              0
              • dingleberryD Offline
                dingleberryD Offline
                dingleberry
                wrote on sidst redigeret af
                #1425

                US ser noget dyster ud her til aften:-(

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                0
                • BulderB Offline
                  BulderB Offline
                  Bulder
                  wrote on sidst redigeret af
                  #1426

                  NBI -3,1%. Så vi skal meget
                  gerne ha' nogle gode PMI-tal fra Kina i nat.

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                  0
                  • DarvinD Offline
                    DarvinD Offline
                    Darvin
                    wrote on sidst redigeret af
                    #1427

                    Skrev lige en lille teaser eller opmuntring i debatten nu hvor vi ikke kan finde ud af at sætte den rette kurs

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                    0
                    • DarvinD Offline
                      DarvinD Offline
                      Darvin
                      wrote on sidst redigeret af
                      #1428

                      😉

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                      0
                      • J Offline
                        J Offline
                        jkj
                        wrote on sidst redigeret af
                        #1429

                        Her er også en lille teaser, imens vi venter http://www.biopharmadive.com/news/jjgenmab-unveil-promising-data-for-a-potential-multiple-myeloma-superstar/404734/

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                        0
                        • Helge_LarsenPI-redaktørH Offline
                          Helge_LarsenPI-redaktørH Offline
                          Helge_LarsenPI-redaktør
                          wrote on sidst redigeret af
                          #1430

                          Tak Darvin for et godt indspark: http://www.proinvestor.com/?p=debat_1&postid=73067&thread=50&start=

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