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Anavex indsender ansøgning til EMA den 26. november 2024!!

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Denne tråd er blevet slettet. Kun brugere med emne behandlings privilegier kan se den.
  • D Offline
    D Offline
    deleted-user
    wrote on sidst redigeret af
    #138

    Anavex På Gabelles præsentation kan man se en henvisning på den endnu ikke udgivet Peer Review.

    Logoet viser navnet Elsevier!
    Peer Reviewet står som "in press"

    Umiddelbar en stor og anerkendt udgiver af videnskabelige artikler.
    Har samlet lidt søgeresultater - men andre må gerne melde ind, hvis de har et bedre kendskab til selskaber.

    Company type Subsidiary
    Industry Publishing
    Founded 1880; 144 years ago
    Headquarters Amsterdam, Netherlands
    Key people Kumsal Bayazit, Chief Executive Officer
    Revenue £2.909 billion (2022)[1]
    Operating income £1.078 billion (2022)[1]
    Net income £2.021 billion (2022)[2]
    Number of employees 9500[3]
    Parent RELX
    Website www.elsevier.com

    1. Is Elsevier publication good?
      Elsevier is a very well-known academic publisher. It publishes more than 2,000 journals and has more than 25,000 editors on its editorial boards. It also has some of the highest impact factors journals in their field. Elsevier has a reputation for publishing high-quality peer-reviewed research. This means that their publications are reviewed by other researchers in the same field, and that they have sound scientific methodology.

    Link Preview Image
    AVXL: Anavex Life Sciences Corp Latest Stock Price, Analysis, News and Trading Ideas

    Get real-time Anavex Life Sciences Corp (AVXL) stock price, news, financials, community insights, and trading ideas. Join 10 million+ investors and traders tracking markets in real-time on Stocktwits.

    favicon

    Stocktwits (stocktwits.com)

    Link Preview Image
    Elsevier | A global leader for advanced information and decision support in science and healthcare

    Elsevier provides advanced information and decision support to accelerate progress in science and healthcare worldwide.

    favicon

    www.elsevier.com (www.elsevier.com)

    Link Preview Image
    Elsevier - Wikipedia

    favicon

    (en.wikipedia.org)

    1 Reply Last reply
    13
    • B Offline
      B Offline
      Boersboe
      wrote on sidst redigeret af
      #139

      Anavex

      Elsevier er et forlag som udgiver mange tidsskrifter. Indikerer ikke rigtig noget om hvorvidt det er godt eller ej. Det er ikke the lancet eller nejm- desværre.

      1 Reply Last reply
      6
      • digafarmD Offline
        digafarmD Offline
        digafarm
        wrote on sidst redigeret af
        #140

        Fra Wiki: "The Lancet has been owned by Elsevier since 1991"

        1 Reply Last reply
        11
        • SolsenS Offline
          SolsenS Offline
          Solsen
          wrote on sidst redigeret af
          #141

          Lidt om forfatterne fra FB gruppen (Alex Pechey):

          The list of those with their name on the peer review paper seems to be out on stocktwits from Dr Gabelle's slides.

          Chat GPT gave me brief summary of them:

          Stephen Macfarlane
          A psychiatrist specializing in aged care, Dr. Macfarlane has extensive experience in dementia research and clinical practice. He has held leadership roles in various healthcare organizations and contributed to numerous studies on Alzheimer's disease.

          Timo Grimmer
          Dr. Grimmer is a neurologist with a focus on neurodegenerative diseases, particularly Alzheimer's disease. Based in Germany, he has authored multiple publications on dementia diagnostics and therapeutics.

          Ken Teo
          Dr. Teo is a clinical researcher with expertise in neurology and pharmacology. His work includes clinical trials and studies related to neurodegenerative disorders.

          Terence J. O'Brien
          Professor O'Brien is a neurologist specializing in epilepsy and neurodegenerative diseases. He holds a leadership position at the University of Melbourne and has an extensive publication record in neurology.

          Michael Woodward
          Associate Professor Woodward is a geriatrician with a focus on Alzheimer's disease and dementia. He has been involved in numerous clinical trials and has contributed significantly to dementia research in Australia.

          Jennifer Grunfeld
          Dr. Grunfeld is a neurologist with expertise in cognitive disorders, including Alzheimer's disease. She has participated in various research studies and clinical trials related to dementia.

          Alastair Mander
          Dr. Mander is a biostatistician with experience in clinical trial design and analysis. His expertise includes statistical methodologies for medical research, particularly in neurology.

          Amy Brodtmann
          Associate Professor Brodtmann is a neurologist specializing in stroke and cognitive decline. She has a strong research background in neuroimaging and dementia, with numerous publications in the field.

          Bruce J. Brew
          Professor Brew is a neurologist with expertise in neurodegenerative diseases and neurovirology. He has an extensive publication record and has contributed significantly to understanding neurological complications of systemic diseases.

          Philip Morris
          Dr. Morris is a psychiatrist with a focus on neurodegenerative disorders, including Alzheimer's disease. He has been involved in clinical research and has contributed to studies on dementia and mental health in aging populations

          1 Reply Last reply
          11
          • B Offline
            B Offline
            Boersboe
            wrote on sidst redigeret af
            #142

            @digafarm

            Fair nok. Min fejl. Nejm er ikke. Ændrer ikke ved budskabet.

            1 Reply Last reply
            3
            • D Offline
              D Offline
              deleted-user
              wrote on sidst redigeret af
              #143

              Anavex angivelig skulle journalnavnet komme frem, når skyggen fjernes.

              The Journal of Prevention of Alzheimer's disease
              (Udkommer i løbet af januar 2025)

              Link Preview Image

              Audrey Gabelles præsentation.

              Link Preview Image
              Blarcamesine_presentation USPALZ_Gabelle_version finale4 en.pdf

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              Google Docs (drive.google.com)

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              7
              • O Offline
                O Offline
                otul
                wrote on sidst redigeret af
                #144

                Det vil sige, at Peer Review sådan set godt kunne komme i Lancet ?

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                2
                • H Offline
                  H Offline
                  Hyst
                  wrote on sidst redigeret af
                  #145

                  Impact factor 8.5 is ok I think - not the top, but within 7-8 percent of the best.

                  It must be reviewers with high degree of statistc understanding.

                  1 Reply Last reply
                  3
                  • H Offline
                    H Offline
                    Hyst
                    wrote on sidst redigeret af
                    #146

                    Nej, det vil jeg ikke mene, hvis det var en kur ja, men det er det jo ikke.

                    1 Reply Last reply
                    2
                    • S Offline
                      S Offline
                      Steen 0
                      wrote on sidst redigeret af
                      #147

                      Som jeg læser det vil peer reviewet blive udgivet i "JPAD The Journal of Prevention of Alzheimer's Disease". Publikationen er hidtil ejet af Springer, men vil overgå til Elsevier per 1/1/2025

                      https://link.springer.com/journal/42414

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                      8
                      • B Offline
                        B Offline
                        Boersboe
                        wrote on sidst redigeret af
                        #148

                        Anavex
                        Såfremt der er tale om "JPAD" er det efter min mening godkendt. Impact på 7-8 er ganske udmærket. Jeg glæder mig til at læse artiklen.

                        1 Reply Last reply
                        3
                        • T Offline
                          T Offline
                          TTTDK
                          wrote on sidst redigeret af
                          #149

                          Trader17. Du har ret. Hvis ansøgninen blev accepteret ved slut november, og listen først er trukket i start december (deres møde var vist den 10.dec.), så skal Blarcamesine figurer på dec listen.

                          Spændende om julemanden når frem inden jul.
                          Men det kræver også, at nogle fortæller os det.

                          1 Reply Last reply
                          6
                          • D Offline
                            D Offline
                            deleted-user
                            wrote on sidst redigeret af
                            #150

                            Anavex Både Audrey Gabelle og Marwan Sabbagh er editor på JPAD.

                            Link Preview Image
                            Editorial board • The Journal of Prevention of Alzheimer's Disease

                            favicon

                            (www.jpreventionalzheimer.com)

                            JPAD ligger som nr. 3 på top 10 af mest betydningsfulde Alzheimer journals.
                            https://www.rxcomms.com/blog/top-alzheimers-journals

                            Spekulation.
                            Nu ved vi mere eller mindre uofficielt , at Anavex har positive OLE data, fra abstrakt fra april 2025 præsentationen på AD/PD.
                            Vi har af omveje også sandsynligvis fået afsløret at Peer Reviewet bliver udgivet meget snart i JPAD.

                            • Anavex har dog ikke selv meldt noget ud om dette?

                            Vi ved også at ansøgningen til EMA er indsendt senest den 26. november 2024.
                            Årsagen kunne være, at når vi stadig ikke har fået en tilbagemelding/accept fra EMA, at Anavex måske ikke ønsker at virke for overmodig overfor EMA, men udviser derimod ydmyghed og respekt for EMAs beslutningsproces indtil denne er afsluttet?

                            Vi må se, tror dog stadig vi får noget mere fra Anavex i dag eller senest på CC den 23. december, hvor ellers forhåbentlige kritiske og aktive analytikere må kunne stille nogle skarpe spørgsmål, som Missling skal svare på i et eller andet uddybende omfang.
                            Især kan det halv offentlige kendskab til de positive OLE data måske anses som et problem, hvis disse kan anses som markedspåvirkende nyheder/viden, som Anavex måske burde have formidlet offentlig - uden at komme i klemme med SEC?

                            1 Reply Last reply
                            17
                            • D Offline
                              D Offline
                              deleted-user
                              wrote on sidst redigeret af
                              #151

                              Anavex Husk årsrapport den 23.december.

                              Webcast kl. 14.30 DK-tid.

                              Management will host a conference call on Monday, December 23, at 8:30 am ET to review financial results and provide an update on the execution of the Company's growth strategy. Following management's remarks, there will be a question-and-answer session.

                              The live webcast of the conference call will be available on Anavex's website at www.anavex.com.

                              Link Preview Image
                              Anavex Life Sciences to Announce Fiscal 2024 Fourth Quarter Financial Results on Monday, December 23, 2024

                              Webcast and Conference Call To be Held Monday, December 23, 2024, 8:30 am ETNEW YORK, Dec. 16, 2024 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company focused on developing innovative treatments for Alzheimer's disease, Parkinson's disease, schizophrenia, neurodevelopmental, neurodegenerative, and rare diseases, including Rett syndrome, and other central nervous system (CNS) disorders, today announced that it will

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                              Yahoo Finance (finance.yahoo.com)

                              Når jeg kigger tilbage, kan jeg ikke se at Anavex har afholdt en årsrapport så sent - ca. 1 mdr. senere end de foregående år.
                              Årsagen kan muligvis/sandsynligvis være, at man ville have nogle vigtige brikker til at falde på plads inden afholdes af årsrapporten.
                              Har sjælden været så spændt på deres PR kl. 13.00, hvor selve indholdet for indlægget fra CEOen er tilgængelig.
                              Håber også, at antallet af analytikere øges med mere end de sædvanlige 2-3 stykker - og så gerne analytikere fra de større investerings institutioner møde op.
                              Missling må bla. skulle forholde sig til de lækkede positive OLE TLD og afsløring af journalen for Peer Reviewet, samt evt. tilbagemelding fra EMA vedr. MAA ansøgningen.
                              Dette års årsrapport ville være de passende rammer for at indvarsle næste trin i udviklingen af Anavex casen.

                              1 Reply Last reply
                              16
                              • M Offline
                                M Offline
                                Milito
                                wrote on sidst redigeret af
                                #152

                                Vi må se om det for en sjælden gangs skyld dukker noget reelt nyt op i dag på CC'en. Jeg vil ikke forvente ret meget, da der i så fald er en ganske reel risiko for skuffelse. Som du skriver ved vi at ansøgningen er indsendt til EMA, at data tilsyneladende er lovende og at det længe ventede Peer review er på trapperne. Det er julegaver som jeg i den grad er fint tilfredse med.

                                1 Reply Last reply
                                9
                                • S Offline
                                  S Offline
                                  Steen 0
                                  wrote on sidst redigeret af
                                  #153

                                  Måske en partnerskabs-aftale? Det vil ihvertfald være en syg dag at annoncere dårlige nyheder på!?
                                  Glædelig Jul til alle!

                                  1 Reply Last reply
                                  6
                                  • F Offline
                                    F Offline
                                    Fandel
                                    wrote on sidst redigeret af
                                    #154

                                    Tak og i lige måde Steen1...

                                    1 Reply Last reply
                                    3
                                    • L Offline
                                      L Offline
                                      lossen
                                      wrote on sidst redigeret af
                                      #155

                                      EMA har accepteret ansøgningen
                                      https://www.anavex.com/post/blarcamesine-receives-ema-filing-acceptance-for-treatment-of-alzheimer-s-disease

                                      1 Reply Last reply
                                      18
                                      • T Offline
                                        T Offline
                                        Trader17
                                        wrote on sidst redigeret af
                                        #156

                                        Det blev ikke accelerated, men den er blevet accepteret, og det er bare dejligt.
                                        Så blev det alligevel jul i år

                                        1 Reply Last reply
                                        7
                                        • BudweisB Offline
                                          BudweisB Offline
                                          Budweis
                                          wrote on sidst redigeret af
                                          #157

                                          Meget kort CC. Q&A sessionen var en meget tynd kop te. Det blev dog afklaret at de følger den normale godkendelsesproces, hvilket vil sige 210 dage.

                                          1 Reply Last reply
                                          6

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