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Genmab — Juni 2020

Planlagt Fastgjort Låst Flyttet Genmab
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Denne tråd er blevet slettet. Kun brugere med emne behandlings privilegier kan se den.
  • B Offline
    B Offline
    bb
    wrote on sidst redigeret af
    #166

    Ja

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    • B Offline
      B Offline
      bb
      wrote on sidst redigeret af
      #167

      Food and Drug Administration (FDA), har forlænget godkendelsesprocessen for Ofatumumab til behandling af patienter med multipel sklerose med tilbagefald, RMS.

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      • G Offline
        G Offline
        GeorgeBest
        wrote on sidst redigeret af
        #168

        Det er nok årsagen til den svage kursudvikling i dag

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        • B Offline
          B Offline
          bb
          wrote on sidst redigeret af
          #169

          Det fremgår ikke af Børsens artikel hvor lang tid godkendelsesprocessen er blevet udskudt

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          • SolsenS Offline
            SolsenS Offline
            Solsen
            wrote on sidst redigeret af
            #170

            Sikkert. Øv de har ellers investeret i en vaucher.

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            • SolsenS Offline
              SolsenS Offline
              Solsen
              wrote on sidst redigeret af
              #171

              Højst sandsynlig covid-19 relateret forsinkelse.

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              • Helge_LarsenPI-redaktørH Offline
                Helge_LarsenPI-redaktørH Offline
                Helge_LarsenPI-redaktør
                wrote on sidst redigeret af
                #172

                Det må det være.

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                • Helge_LarsenPI-redaktørH Offline
                  Helge_LarsenPI-redaktørH Offline
                  Helge_LarsenPI-redaktør
                  wrote on sidst redigeret af
                  #173

                  Alt andet lige bør det ikke påvirke kursen.

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                  • Helge_LarsenPI-redaktørH Offline
                    Helge_LarsenPI-redaktørH Offline
                    Helge_LarsenPI-redaktør
                    wrote on sidst redigeret af
                    #174

                    Fred være med det.

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                    • G Offline
                      G Offline
                      GeorgeBest
                      wrote on sidst redigeret af
                      #175

                      Men hvorfor nogen bliver usikket på partnerdeal netop i dag, foretår jeg ikke. Jan bekræftede jo timingen endnu engang hos Jefferies

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                      • SolsenS Offline
                        SolsenS Offline
                        Solsen
                        wrote on sidst redigeret af
                        #176

                        https://www.globenewswire.com/news-release/2020/06/02/2042559/0/en/Novartis-provides-update-on-FDA-review-of-ofatumumab-a-self-administered-targeted-B-cell-therapy-for-patients-with-relapsing-multiple-sclerosis.html Meddelelsen

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                        • K Offline
                          K Offline
                          kkjoel
                          wrote on sidst redigeret af
                          #177

                          De søgte i februar og normalt tager denne "priority review" proces 0,5 år. Nu sker det i stedet til september iflg Novartis - ikke megen forsinkelse!

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                          • K Offline
                            K Offline
                            kkjoel
                            wrote on sidst redigeret af
                            #178

                            Fra Novartis pressemedd: "Basel, June 2, 2020 — Novartis today announced that it has received notice from the US Food and Drug Administration (FDA) that the agency has extended its review of the Supplemental Biologics License Application (sBLA) for ofatumumab (OMB 157), a self-administered, targeted B-cell therapy for patients with relapsing multiple sclerosis. Regulatory action is now expected in September 2020."

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                            • K Offline
                              K Offline
                              kkjoel
                              wrote on sidst redigeret af
                              #179

                              Link Preview Image
                              Novartis provides update on FDA review of ofatumumab, a self-administered, targeted B-cell therapy for patients with relapsing multiple sclerosis

                              favicon

                              Novartis (www.novartis.com)

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                              • G Offline
                                G Offline
                                GeorgeBest
                                wrote on sidst redigeret af
                                #180

                                Vi er jo stadig i 2. kvartal...

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                                0
                                • G Offline
                                  G Offline
                                  GeorgeBest
                                  wrote on sidst redigeret af
                                  #181

                                  Jan bekræftede timing i dag, så jeg er optimist...

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                                  • G Offline
                                    G Offline
                                    gentogen
                                    wrote on sidst redigeret af
                                    #182

                                    Novartis opkyste i februar forventet godkendelse i juni, så det ligner en forlængelse på tre måneder https://www.novartis.com/news/media-releases/novartis-announces-fda-and-ema-filing-acceptance-ofatumumab-novel-b-cell-therapy-patients-relapsing-forms-multiple-sclerosis-rms

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                                    • G Offline
                                      G Offline
                                      gentogen
                                      wrote on sidst redigeret af
                                      #183

                                      The FDA has warned that they may not be able to sustain its current levels of timely reviews and approvals of marketing applications due to staff being reallocated to working on the COVID-19 coronavirus pandemic.

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                                      • G Offline
                                        G Offline
                                        gentogen
                                        wrote on sidst redigeret af
                                        #184

                                        301 Moved Permanently

                                        favicon

                                        (www.pharmafile.com)

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                                        • SolsenS Offline
                                          SolsenS Offline
                                          Solsen
                                          wrote on sidst redigeret af
                                          #185

                                          Sarclica bl.a. side 19+20, hvor kombien med kyprolis virker som et godt match https://www.sanofi.com/-/media/Project/One-Sanofi-Web/Websites/Global/Sanofi-COM/Home/common/docs/investors/2020_06_02_ASCO_call_final.pdf?la=en&hash=ED7CCD8B204BECF6ACFC8612FBA5A3A7 Men de har ikke turde gå h2h med dara.

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