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Genmab — Marts 2019

Planlagt Fastgjort Låst Flyttet Genmab
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  • P Offline
    P Offline
    polle1
    wrote on sidst redigeret af
    #587

    God morgen og god dag 🙂

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    • Helge_LarsenPI-redaktørH Offline
      Helge_LarsenPI-redaktørH Offline
      Helge_LarsenPI-redaktør
      wrote on sidst redigeret af
      #588

      Just a moment...

      favicon

      (www.proinvestor.com)

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      • G Offline
        G Offline
        gentogen
        wrote on sidst redigeret af
        #589

        EL: About your comment 23:10 I think you should look at page 14 where the PDUFA date for Ribociclib 28/12 is explaines as the PDUFA date that 'normally' would have been the date but actually the drug was approved July 18

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        • G Offline
          G Offline
          gentogen
          wrote on sidst redigeret af
          #590

          So as I see it the table is explaining the advantage of RTOR

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          • E Offline
            E Offline
            E_L
            wrote on sidst redigeret af
            #591

            you are definately correct. I think Bulders' question was more if there was a different PDUFA date for an RTOR. I can not find anywhere that this is the case. The press release showed no date.

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            • E Offline
              E Offline
              E_L
              wrote on sidst redigeret af
              #592

              PDUFA dates are deadlines for the FDA to review new drugs and for priority review the FDA has 6 months to review ; i assume that is the same here, but this is only the MAXIMUM time; the RTOR is offcourse meant to make it much faster

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              • E Offline
                E Offline
                E_L
                wrote on sidst redigeret af
                #593

                looking at the other examples, i think there is a good chance we could get it somewhere at/towards the end of april? but it CAN take longer

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                • StockBullS Offline
                  StockBullS Offline
                  StockBull
                  wrote on sidst redigeret af
                  #594

                  Altid noget Alligator Bio rykker lidt idag. Mon ikke den bunder her omkring 20-21 kr

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                  • StockBullS Offline
                    StockBullS Offline
                    StockBull
                    wrote on sidst redigeret af
                    #595

                    Men godt nok mager volumen

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                    • BulderB Offline
                      BulderB Offline
                      Bulder
                      wrote on sidst redigeret af
                      #596

                      I think you are right E L. The PDUFA date is 6 mths from submission. But only in the case that RTOR doesn't work. If the application is changed to normal/priority review. If RTOR works it'll be conciderably shorter, but still flexible.

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                      • A Offline
                        A Offline
                        AaBforever
                        wrote on sidst redigeret af
                        #597

                        Ja der er ikke meget "svung" opad på denne nyhed.

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                        • StockBullS Offline
                          StockBullS Offline
                          StockBull
                          wrote on sidst redigeret af
                          #598

                          Hvad er konklusionen m.h.t RTOR ? godkendelse inden 4 uger ? 🙂

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                          0
                          • Helge_LarsenPI-redaktørH Offline
                            Helge_LarsenPI-redaktørH Offline
                            Helge_LarsenPI-redaktør
                            wrote on sidst redigeret af
                            #599

                            Just a moment...

                            favicon

                            (www.proinvestor.com)

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                            0
                            • A Offline
                              A Offline
                              AaBforever
                              wrote on sidst redigeret af
                              #600

                              Konklusionen er nok at ingen ved det...

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                              0
                              • A Offline
                                A Offline
                                AaBforever
                                wrote on sidst redigeret af
                                #601

                                Gætværk..som vi siger heroppe nordpå..:-)

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                                0
                                • StockBullS Offline
                                  StockBullS Offline
                                  StockBull
                                  wrote on sidst redigeret af
                                  #602

                                  også min konklusion 🙂

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                                  0
                                  • StockBullS Offline
                                    StockBullS Offline
                                    StockBull
                                    wrote on sidst redigeret af
                                    #603

                                    måske man skulle spørge den ny informationschef 🙂

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                                    0
                                    • BulderB Offline
                                      BulderB Offline
                                      Bulder
                                      wrote on sidst redigeret af
                                      #604

                                      Ja, havde det været R. Gravesen ville hun have svaret "soon".

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                                      • S Offline
                                        S Offline
                                        Sukkeralf
                                        wrote on sidst redigeret af
                                        #605

                                        ....and Jan "very soon" or "within weeks"

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                                        0
                                        • BulderB Offline
                                          BulderB Offline
                                          Bulder
                                          wrote on sidst redigeret af
                                          #606

                                          Den nye (Peron): mañana

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