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  3. Hansa Biopharma
  4. Hansa Biopharma — Maj 2023

Hansa Biopharma — Maj 2023

Planlagt Fastgjort Låst Flyttet Hansa Biopharma
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  • exitnuE Offline
    exitnuE Offline
    exitnu
    wrote on sidst redigeret af
    #23

    FDA says there isn't persuasive evidence that expression of Sarepta's micro-dystrophin correlates to an improvement in NSAA score.

    1 Reply Last reply
    0
    • Helge_LarsenPI-redaktørH Offline
      Helge_LarsenPI-redaktørH Offline
      Helge_LarsenPI-redaktør
      wrote on sidst redigeret af
      #24

      https://www.fda.gov/media/168021/download

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      0
      • exitnuE Offline
        exitnuE Offline
        exitnu
        wrote on sidst redigeret af
        #25

        Max Bayer (staff writer @FierceBiotech covering new drug development)

        1 Reply Last reply
        0
        • Helge_LarsenPI-redaktørH Offline
          Helge_LarsenPI-redaktørH Offline
          Helge_LarsenPI-redaktør
          wrote on sidst redigeret af
          #26

          FDA presentation has concluded. Q&A now. https://twitter.com/maxonwifi/status/1657090567497474050

          1 Reply Last reply
          0
          • exitnuE Offline
            exitnuE Offline
            exitnu
            wrote on sidst redigeret af
            #27

            Logger ud - god aften til ALLE!

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            0
            • Helge_LarsenPI-redaktørH Offline
              Helge_LarsenPI-redaktørH Offline
              Helge_LarsenPI-redaktør
              wrote on sidst redigeret af
              #28

              Tak exitnu...Jeg følger Q&A. Umiddelbart ser det ikke godt ud for det videre forløb for Sarepta.

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              0
              • Helge_LarsenPI-redaktørH Offline
                Helge_LarsenPI-redaktørH Offline
                Helge_LarsenPI-redaktør
                wrote on sidst redigeret af
                #29

                FDA advisors say the benefit-risk profile of SRP-9001 DOES support accelerated approval. The votes:
                Yes: 8

                No: 6

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                0
                • exitnuE Offline
                  exitnuE Offline
                  exitnu
                  wrote on sidst redigeret af
                  #30

                  FDA advisers narrowly vote in favor of Sarepta's DMD gene therapy

                  Just a moment...

                  favicon

                  (www.fiercebiotech.com)

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                  • exitnuE Offline
                    exitnuE Offline
                    exitnu
                    wrote on sidst redigeret af
                    #31

                    "Experts from the Cellular, Tissue, and Gene Therapies Advisory Committee narrowly voted 8 to 6 that the benefit-risk profile of SRP-9001 was strong enough to support accelerated approval even as questions about the gene therapy's efficacy linger."

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                    0
                    • exitnuE Offline
                      exitnuE Offline
                      exitnu
                      wrote on sidst redigeret af
                      #32

                      ""I think we owe it to the patients to help them intervene," said committee member and consumer representative Kathleen O’Sullivan-Fortin, who voted in favor. Others expressed confidence in the safety profile of the gene therapy even amid concerns about the efficacy."

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                      0
                      • exitnuE Offline
                        exitnuE Offline
                        exitnu
                        wrote on sidst redigeret af
                        #33

                        Sarepta Therapeutics Announces Positive Vote from U.S. FDA Advisory Committee Meeting for SRP-9001 Gene Therapy to Treat Duchenne Muscular Dystrophy

                        https://www.businesswire.com/news/home/20230512005452/en/Sarepta-Therapeutics-Announces-Positive-Vote-from-U.S.-FDA-Advisory-Committee-Meeting-for-SRP-9001-Gene-Therapy-to-Treat-Duchenne-Muscular-Dystrophy

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                        0
                        • exitnuE Offline
                          exitnuE Offline
                          exitnu
                          wrote on sidst redigeret af
                          #34

                          Så nu er det med at holde øje med mandag d. 29 maj: "The Biologics License Application (BLA) for SRP-9001 is currently under priority review by the FDA with a regulatory action date of May 29, 2023."

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                          0
                          • M Offline
                            M Offline
                            Munchi
                            wrote on sidst redigeret af
                            #35

                            ja lange 14 dage vi skal vente ... 8-6 ikke overbevisende men forhåbentligt ok

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                            0
                            • B Offline
                              B Offline
                              B.Andersen
                              wrote on sidst redigeret af
                              #36

                              Der er vist ikke særlig mange som har fanget det seneste nye omkring Sarepta og FDA. Havde forventet en noget større reaktion i dag.

                              1 Reply Last reply
                              0
                              • A Offline
                                A Offline
                                Aps_invest
                                wrote on sidst redigeret af
                                #37

                                6,5% op nu….nok mange der har brændt fingrene lidt, og holder sig lidt tilbage 🙂 Lad os håbe på et lille shorts squeze kan tænde raketten 🙂

                                1 Reply Last reply
                                0
                                • M Offline
                                  M Offline
                                  MBCruise
                                  wrote on sidst redigeret af
                                  #38

                                  @B.Andersen - Tror ikke at Sarepta sagen er helt hjemme endnu. Med stemmerne 8-6 er der vel stadig stor risiko for at beslutningen kan gå den forkerte vej. Men spændende bliver det.

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                                  0
                                  • M Offline
                                    M Offline
                                    MBCruise
                                    wrote on sidst redigeret af
                                    #39

                                    Kan iøvrigt anbefale William Blair´s Fireside chat fra i fredags med Hansa. De er rimelig skarpe på Hansa og har også lavet en god analyse (65 sider)

                                    1 Reply Last reply
                                    0
                                    • B Offline
                                      B Offline
                                      B.Andersen
                                      wrote on sidst redigeret af
                                      #40

                                      Mbcruise..Jeg tror at alle os der har fulgt forløbet med ekspertudvalget fredag ved, at sagen ikke er afgjort endnu. Men da ekspertudtalelser, i forbindelse med eventuel fast track til medicin i tidlig faseforsøg til alvorlige sygdomme uden anden reel god behandlingsmulighed, er eksperterne anbefaling ofte meget delte.

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                                      0
                                      • B Offline
                                        B Offline
                                        B.Andersen
                                        wrote on sidst redigeret af
                                        #41

                                        8-6 i favør for Sarepta burde i den sammenhæng gøre nogen af de mange shortere nervøse. En positiv afgørelse om 14 dage vil betyde en meget stor stigning i kursen på Hansa Biopharma.

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                                        0
                                        • B Offline
                                          B Offline
                                          B.Andersen
                                          wrote on sidst redigeret af
                                          #42

                                          Just a moment...

                                          favicon

                                          (proinvestor.com)

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                                          0

                                          Hello! It looks like you're interested in this conversation, but you don't have an account yet.

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