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Genmab — Juli 2018

Planlagt Fastgjort Låst Flyttet Genmab
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  • E Offline
    E Offline
    E_L
    wrote on sidst redigeret af
    #418

    anyway, who has enough procedural knowledge to know, if PRAC gives a positive advice to CHMP, is it possible for CHMP to approve immediately in their next meeting?

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    • M Offline
      M Offline
      mobbyduck1
      wrote on sidst redigeret af
      #419

      from positive CHMP, it is still gonna take 67 days to approval??

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      • Legolas23L Offline
        Legolas23L Offline
        Legolas23
        wrote on sidst redigeret af
        #420

        @Bulder ? @Sukkeralf ? @Solsen ?

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        • G Offline
          G Offline
          gentogen
          wrote on sidst redigeret af
          #421

          Det hedder, at "The PRAC is responsible for assessing all aspects of risk management of human medicines" , så umiddelbart ville jeg gætte på, at det lige passer med tidsplanen til næste CHMP i slutningen af juli

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          • G Offline
            G Offline
            gentogen
            wrote on sidst redigeret af
            #422

            og at de altså reelt afgør det.

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            • M Offline
              M Offline
              mobbyduck1
              wrote on sidst redigeret af
              #423

              men det tager stadig 67 dage til approval derfra ikke??

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              • StockBullS Offline
                StockBullS Offline
                StockBull
                wrote on sidst redigeret af
                #424

                Ser ud til shorterne er begyndt at reducere lidt: April snit 4.25% shortet. Maj 4.14%, Juni 3.84%

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                • S Offline
                  S Offline
                  Sukkeralf
                  wrote on sidst redigeret af
                  #425

                  Mobby - jo ca 2 måneder

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                  • BulderB Offline
                    BulderB Offline
                    Bulder
                    wrote on sidst redigeret af
                    #426

                    Mest sandsynligt at hvis PRAC ingen indvendinger har, så kommer det på CHMPs næste møde, og i tilfælde af anbefaling, EU-godkendelse 60 dage senere.

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                    • M Offline
                      M Offline
                      mobbyduck1
                      wrote on sidst redigeret af
                      #427

                      så vi snakker sept/Okt i bedste fald?

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                      • BulderB Offline
                        BulderB Offline
                        Bulder
                        wrote on sidst redigeret af
                        #428

                        Ja slutningen af september. Men det reelle er jo CHMP's anbefaling, som så gerne skulle komme d. 27. ds. EU-godkendelsen er kun formel. Men det tager 60 dage at nå rundt i medlemslandene, som hver især skal godkende.

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                        • BulderB Offline
                          BulderB Offline
                          Bulder
                          wrote on sidst redigeret af
                          #429

                          I øvrigt udsender PRAC highlights på fredag. Kan være at der står noget om, hvad de indstiller til CHMP.

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                          • JørgenVarnæsJ Offline
                            JørgenVarnæsJ Offline
                            JørgenVarnæs
                            wrote on sidst redigeret af
                            #430

                            Tak Bulder. Det er også mit indtryk, at ema ikke fraviger deres procedurer for noget som helst. Når nu klokken blev stoppet på processen, så kan man ikke slippe billigere end med en måneds forsinkelse.

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                            • B Offline
                              B Offline
                              bibob
                              wrote on sidst redigeret af
                              #431

                              God morgen. 🙂

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                              • T Offline
                                T Offline
                                transalp
                                wrote on sidst redigeret af
                                #432

                                Go morgen:)

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                                • Helge_LarsenPI-redaktørH Offline
                                  Helge_LarsenPI-redaktørH Offline
                                  Helge_LarsenPI-redaktør
                                  wrote on sidst redigeret af
                                  #433

                                  God morgen. 🙂

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                                  0
                                  • P Offline
                                    P Offline
                                    Plimsoller
                                    wrote on sidst redigeret af
                                    #434

                                    God morgen 🙂

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                                    • S Offline
                                      S Offline
                                      saltpeter
                                      wrote on sidst redigeret af
                                      #435

                                      July 12, 2018 5:57 AM UTC
                                      Genmab Enters Strategic Partnership with Immatics to Discover and Develop Next Generation Bispecific Cancer Immunotherapies

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                                      • S Offline
                                        S Offline
                                        saltpeter
                                        wrote on sidst redigeret af
                                        #436

                                        Genmab gains exclusive access to multiple novel proprietary tumor targets identified by Immatics Biotechnologies’ XPRESIDENT® technology
                                        Creation of novel immuno-oncology drugs combining Genmab and Immatics’ proprietary technologies
                                        Genmab responsible for development, manufacturing and commercialization worldwide
                                        Immatics to receive upfront payment of USD 54 million from Genmab

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                                        • S Offline
                                          S Offline
                                          saltpeter
                                          wrote on sidst redigeret af
                                          #437

                                          The deal strengthens Genmab’s position in immuno-oncology by combining Genmab's proprietary technologies and antibody know-how with Immatics' XPRESIDENT® targets and T-cell receptor (TCR) capabilities. Genmab will receive an exclusive license to three proprietary targets from Immatics, with an option to license up to two additional targets at predetermined economics. The companies will conduct joint research, funded by Genmab, on multiple antibody and/or TCR-based bispecific therapeutic product

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