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Genmab — Juni 2020

Planlagt Fastgjort Låst Flyttet Genmab
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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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            0
            • 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.

                  1 Reply Last reply
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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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                                0
                                • 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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                                      0
                                      • 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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                                        • Helge_LarsenPI-redaktørH Offline
                                          Helge_LarsenPI-redaktørH Offline
                                          Helge_LarsenPI-redaktør
                                          wrote on sidst redigeret af
                                          #186

                                          God morgen. 🙂

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