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Genmab — Maj 2021

Planlagt Fastgjort Låst Flyttet Genmab
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Denne tråd er blevet slettet. Kun brugere med emne behandlings privilegier kan se den.
  • E Offline
    E Offline
    E_L
    wrote on sidst redigeret af
    #682

    Both CHRYSALIS/Amivantamab and the GEN1042 trials had their Estimated Primary Completion Date extended https://clinicaltrials.gov/ct2/history/NCT02609776?A=54&B=55&C=merged#StudyPageTop .https://clinicaltrials.gov/ct2/history/NCT04083599?A=3&B=4&C=merged#StudyPageTop which is a similar situation where i wonder if that is a good or a bad thing

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    • BulderB Offline
      BulderB Offline
      Bulder
      wrote on sidst redigeret af
      #683

      In this case primary completion and completion is not changed, so they are probably not stopping the trial.

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      • S Offline
        S Offline
        Sukkeralf
        wrote on sidst redigeret af
        #684

        Andrew skriver SeaGen styrer dette studie, så ikke meget held der !

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        • S Offline
          S Offline
          Sukkeralf
          wrote on sidst redigeret af
          #685

          Andrew writes that it is SeaGen that runs this study - so no luck there

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          • S Offline
            S Offline
            Sukkeralf
            wrote on sidst redigeret af
            #686

            Such impressive deals on preclinical programs:

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            • S Offline
              S Offline
              Sukkeralf
              wrote on sidst redigeret af
              #687

              Just a moment...

              favicon

              (www.firstwordpharma.com)

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              • M Offline
                M Offline
                martinicph
                wrote on sidst redigeret af
                #688

                Man kunne skrive til, [email protected]. Måske de svarer lige så hurtigt som Andrew. 🙂

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                • troldmandenT Offline
                  troldmandenT Offline
                  troldmanden
                  wrote on sidst redigeret af
                  #689

                  Når et studie standses så tidligt før tid så er det hvis mere reglen end undtagelsen det er dårligt nyt. Så vi skal ud i undtagelsen her hvis det er.... Der bør relativt hurtigt komme meddelelse med begrundelse

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                  • D Offline
                    D Offline
                    deleted-user
                    wrote on sidst redigeret af
                    #690

                    Er studiet ikke forsat aktivt og rekruttering stoppet?

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                    • S Offline
                      S Offline
                      Sukkeralf
                      wrote on sidst redigeret af
                      #691

                      Jo - så helt galt er det ikke

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                      • BulderB Offline
                        BulderB Offline
                        Bulder
                        wrote on sidst redigeret af
                        #692

                        Hvis der var alvorlige AE ville de jo ikke fortsætte med at behandle dem, der er rekrutteret.

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                        • BulderB Offline
                          BulderB Offline
                          Bulder
                          wrote on sidst redigeret af
                          #693

                          Det er nok snarere på effektsiden at hunden ligger begravet.

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                          • S Offline
                            S Offline
                            Sukkeralf
                            wrote on sidst redigeret af
                            #694

                            Or maybe just at stop of recruitment until this have been decided:

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                            • S Offline
                              S Offline
                              Sukkeralf
                              wrote on sidst redigeret af
                              #695

                              The safety run-in period will evaluate the safety of a weekly schedule. The highest dose level that is considered safe will be the recommended phase 2 dose (RP2D) and will be used in Part A. In Part A, participants will be randomized in a 1:1 ratio to receive tisotumab vedotin intravenously (IV) every 3 weeks (Q3W regimen) or the safety run-in RP2D on Days 1, 8, and 15 of every 4-week cycle (weekly regimen; 3Q4W) if a RP2D has been identified. Participants who enroll in Part B will receive tisot

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                              • S Offline
                                S Offline
                                Sukkeralf
                                wrote on sidst redigeret af
                                #696

                                tumab vedotin intravenously (IV) every 3 weeks (Q3W regimen) or the safety run-in RP2D on Days 1, 8, and 15 of every 4-week cycle (weekly regimen; 3Q4W) if a RP2D has been identified. Participants who enroll in Part B will receive tisotumab vedotin on Days 1, 8, and 15 of every 4-week cycle (weekly regimen) at a pre-specified dose level, if the dose level is considered safe and tolerable in the safety run-in period.

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                                • E Offline
                                  E Offline
                                  E_L
                                  wrote on sidst redigeret af
                                  #697

                                  that could also be possible, hadn't thought about that

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                                  • E Offline
                                    E Offline
                                    E_L
                                    wrote on sidst redigeret af
                                    #698

                                    AbbVie routinely hiked prices for Humira, Imbruvica and abused patents to extend monopoly: congressional report https://www.fiercepharma.com/pharma/abbvie-repeatedly-raised-prices-for-humira-imbruvica-and-abused-u-s-patent-system-to-extend

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                                    • E Offline
                                      E Offline
                                      E_L
                                      wrote on sidst redigeret af
                                      #699

                                      I don't think we have to worry that epcoritamab will be sold too cheap with Abbvie as partner...

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                                      • D Offline
                                        D Offline
                                        deleted-user
                                        wrote on sidst redigeret af
                                        #700

                                        Lyttede til Andrew Carlsen på Investorevent fra Nordnet i dag. Bemærker, at han får sagt, at optionen omkring CD38 er en head to head sammenligning med Dara. Kunne man tænke sig, at man har indskrevet præcist hvilket resultat Genmab som minimum skal levere for hexa for, at optionen exercises for, at undgå JnJ spekulerer ensidig i egne økonomisk interesse?

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                                        • BulderB Offline
                                          BulderB Offline
                                          Bulder
                                          wrote on sidst redigeret af
                                          #701

                                          JnJ kan godt vælge at gå ind på basis af nuværende studie, men de kan også vente på et head to head studie. Og endvidere et dara i dlbcl - fandt vi ud af i går. Det kan næppe være beskrevet på forhånd, hvor tærskelen ligger. Det må være op til JnJ suverænt. Lige som med sgen i sin tid med tiso.

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