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Anavex HISTORISKE OG BANEBRYDENDE RESULTATER I ALZHEIMER!!!

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  • SolsenS Offline
    SolsenS Offline
    Solsen
    wrote on sidst redigeret af
    #222

    Lige et citat fra pr på Grimmers optagelse i boarded:

    "I'm excited to join Anavex's Scientific Advisory Board at this time of important growth and evolution of the Company," said Professor Dr. Grimmer. "There is such a significant unmet medical need around the globe caused by Alzheimer's disease and patients in the Phase 2b/3 ANAVEX®2-73-AD-004 study performed better even after a year despite the progression of this devastating disease. It would be groundbreaking for patients and their loved ones if healthcare professionals are able to provide a therapeutic which can be taken orally and is generally safe, which the study indicates, ANAVEX®2-73 (blarcamesine) is a likely candidate."

    Han deltog på seneste cc fra Anavex og var investigator på det nyligt rapporterede fase 2b/3 i AD. Har tidligere deltaget i mange men monoklonare antistoffer imod ophobning af amylin i hjernen.

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    • D Offline
      D Offline
      deleted-user
      wrote on sidst redigeret af
      #223

      Anavex Endnu en der har oplevet effekten af 2-73 på nærmeste hold og ønsker at være med på rejsen og gøre en reel forskel!

      Enten det - eller han bare har sagt ja pga. ussel mammon og med usande udsagn om at AD patienter faktisk bliver bedre?
      Og måske har shorterne ret, at Anavex har pustet deres data op ved udspekulerede fejlberegninger og generel uærlighed omkring deres videnskab.

      Det må være helt op til den enkelte at bedømme!

      Tror dog stadig naivt på, at der er forsker, læger og selskaber, der først og fremmest ønsker det bedste for disse reel ubehandlede indikationer og brænder for at kunne gøre en reel forskel!

      Som jeg tidligere har skrevet, så vil vi få et gennembrud også i Alzheimer på et tidspunkt.
      Måske skal et sådan gennembrud komme fra nogle, som er innovative og ikke fastlåst af traditionelle måder tilgå tingene og som samtidig ikke har afkastet til sig selv og aktionærerne som første og måske eneste prioritet.
      Anavex er indbegrebet af et sådan selskab og alt tyder på, at de har fat den helt rigtige ende på CNS området.

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      • D Offline
        D Offline
        deleted-user
        wrote on sidst redigeret af
        #224

        Anavex Positive Lane Simonian fra Seeking Alpha.

        Anavex Life Sciences: The Little Company That Did
        Dec. 06, 2022 12:51 PM ETAnavex Life Sciences Corp. (AVXL)BIIB, ESALF, ESALY268 Comments
        Lane Simonian profile picture
        Lane Simonian
        2.24K Followers
        Summary

        Anavex's 2-73/blarcamesine produced significant reductions in cognitive decline in early Alzheimer's disease as measured by ADAS-Cog and CDR-SB scores.
        Those who had improvements in cognition did so by an average ADAS-Cog score of 4 points, which is considered to be clinically significant.
        In an earlier phase 2a trial, most (4 out of 6) high concentration patients improved, whereas no medium concentration patients improved.
        The high dose group patients in the phase 2b/3 clinical trial are likely to do considerably better than the pooled 30mg and 50mg group.
        It is very difficult to gauge how the FDA will decide on blarcamesine; such a decision will be critical to Anavex's stock value.

        Sporty man on the mountain peak looking on mountain valley with sunbeams at colorful sunset in autumn in Europe. Landscape with traveler, foggy hills, forest in fall, amazing sky and sunlight in fall

        den-belitsky/iStock via Getty Images

        Anavex Life Sciences Corp. (NASDAQ:AVXL) presented the results from its phase 2b/3 clinical 48-week trial for Anavex 2-73/blarcamesine at the CTAD conference on December 1st (revised presentation). Blarcamesine met its primary and secondary endpoints by significantly reducing cognitive decline as measured by ADAS-Cog and CDR-SB, respectively. Anavex stated that it met its other primary endpoint: reduction in decline in activities of daily living as measured by ADCS-ADL, although it has not provided specific data to support this as of yet (press release). Up to this point, Anavex has provided results from the combined 30mg and 50mg dose groups. However, once separate data is provided for the 50mg group, blarcamesine is likely to be the first Alzheimer's drug or drug candidate to produce a mean improvement in ADAS-Cog scores at 48 weeks.

        One might have expected a greater increase in stock value based on the initial announcement of results. Critics, though, succeeded in creating a lot of noise surrounding Anavex's presentation (and subsequent conference call), teed up in part because the company had not yet completed all the analysis. In the end, though, the one legitimate concern is how will the FDA view the trial. Until that decision is reached, Anavex and its stockholders will be left in a kind of limbo.
        Going by the Numbers

        On average, those on blarcamesine declined by 45 percent less in cognition as measured ADAS-Cog scores and 27 percent less in cognition as measured by CDR-SB scores than those on placebo. Patients who improved on blarcamesine did so by an average of -4.03 points (a smaller score on ADAS-Cog represents an improvement in cognition). Those who improved by at least -.5 points in ADAS-Cog scores on blarcamesine were 84 percent more likely to do so than those on placebo and 167 percent more likely to improve by a clinically significant 3.5 points on ADCS-ADL scores. Since around 65 percent in both groups were on Alzheimer's medications, this is one indirect indication that blarcamesine is more effective than the standard of care. Previous data helps to confirm this. At six months, 20 percent of patients on Aricept improved by an ADAS-Cog score by 4 points or more, in Anavex's phase 2a trial 33 percent of patients in the medium and high concentration groups (4 out of 12 at 57 weeks) improved by an ADAS-cog score of 4 points or more, and 66 percent in the high concentration group (four out of six) improved by an ADAS-Cog score of 4 points or more (Anavex used MMSE scores in the phase 2a trial; a one-point change in MMSE scores equates to about a two-point change in ADAS-Cog scores) (charts on pp. 23, 29). At 57 weeks, the high concentration group improved by a mean 2 MMSE points, at 70 weeks they improved by a mean of 3 MMSE points, and at 148 weeks they declined by a mean of around 1 MMSE point.

        Some points of note regarding this. No one in the medium concentration group improved at 57 weeks, so pooling medium and high dose numbers in the phase 2b/3 trial likely diluted the drug's effects. On the other hand, excluding sigma-1 receptor variants from treatment effects in the larger trial improved results. If around half the population with early Alzheimer's disease improves cognitively at around a year, and they remained nearly stable for three years, that marks a major breakthrough in the treatment of early Alzheimer's disease.

        In regards to safety, Anavex has stated that most of the side effects have been either mild or moderate, with dizziness and confused state being the most common. These side effects led to 17 dropouts out of 37 in total in the drug group (out of 338 participants). In the conference call, Anavex largely did not address the severity or timing of these side effects. The company suggested that the problem of dizziness was usually mild and might be avoided by taking the drug before bedtime. For confusion, this was at least sometimes resolved by down-titration of the drug. More details are needed on whether anyone else dropped out of the trial due to rare side effects (whether related or unrelated to the drug) and what those side effects were.

        What seems abundantly clear, though, is that no one died from blarcamesine, and unlike most anti-amyloid drugs there were no problems with brain swelling or brain bleeds. The great irony behind Eisai Co., Ltd. (OTCPK:ESALY) and Biogen's (BIIB) drugs is that they only slow the progression of the disease in APOE4 carriers, but these are the patients most likely to have severe and even fatal reactions to the drug (Ban2401/lecanemab: table 16, aducanumab: p. 58/12). Blarcamesine is both far safer than most anti-amyloid drugs and much more effective, at least at the highest dose.
        Going by the Science

        Blarcamesine is a sigma-1 receptor agonist. Sigma-1 receptor agonists inhibit the release of intracellular calcium into the cytosol. This limits oxidative stress, nitrosative stress, neuroinflammation, and mitochondrial dysfunction in early Alzheimer's disease and likely in a number of other neurological diseases and conditions.

        Neurotoxicity

        Pathways in Neurological Diseases (Frontiers in Cellular Neuroscience)

        As Alzheimer's progresses, calcium influx rather than calcium release from the endoplasmic reticulum becomes the major problem. To a certain extent, sigma-1 receptors may limit calcium influx. Blarcamesine, a tetrahydrofuran derivative, potentially is also a peroxynitrite scavenger (ONOO-), which may at least partially explain why it is more effective than the sigma-1 receptor agonist Aricept at the highest dose. But as the disease progresses, some of the enzymes and receptor types on the right side of the chart are damaged by oxidation and nitration (g protein-coupled receptors and protein kinase C, for instance), so the primary function of sigma-1 receptor agonists in terms of treating Alzheimer's disease is lost.

        Anavex's next clinical trial results will be for pediatric Rett syndrome, which is part of the autism spectrum disorder. Many of the same routes as displayed in the chart above lead to Rett syndrome. Especially for pediatric Rett's, then, one should expect good results from Anavex. Beyond that, the severity of the disease state may in part determine when blarcamesine could best help in the treatment of a variety of neurological diseases and conditions.
        What Will the FDA Do?

        The FDA does consider the results of clinical trials run outside of the United States if meeting certain criteria, and it may accept results from clinical trials with as low as 300 participants (Anavex is cutting it very close if you remove the 30mg group). Whether it will do so in the case of blarcamesine is very difficult to predict. The out route for them would be to approve the drug which would be the best currently available treatment of Alzheimer's disease but require further confirmatory trials. Separate from this, regulatory agencies in other countries such as Australia and Canada, potentially could grant approval to blarcamesine, with or without additional confirmatory trials.
        Challenges and Outlook

        Anavex would face some difficult decisions if it needs to run another phase 3 clinical trial without the ability to sell blarcamesine. The company still has $149.2 million cash or cash equivalents on hand, which would be enough to run another phase 3 clinical trial for Alzheimer's disease (financial information). There is a potential for a partnership of some kind, but big pharmaceutical companies in the Alzheimer's field have either given up on finding a treatment altogether or keep plowing ahead with anti-amyloid treatments.

        In the short term, the best thing the company could do would be to release the data for the 50mg group. This may take time, as several participants were either titrated up or more often titrated down during the course of the trial to address tolerability issues. That is why the 30mg and 50mg groups were pooled. In the meantime, Anavex could give the number of participants who improved on either dose, but if almost no one improved on the low dose and 100 people on the high dose improved, the pooled number does not look very impressive. The risk for investors in the long-term is not so much the initial criticisms, some of which have already been refuted by the company (such as the math "error") or by the results themselves, but if the data is convincing enough for the FDA to grant some form of approval. Anavex keeps repeating that phase 2b/3 results are consistent with phase 2a results and that further data will be even better. They, I believe, are right on both points. So the FDA's decision really comes down to the points I discussed above (size of the trial and no U.S. sites).

        It has taken seven years for Anavex to get to this point, with a very methodical and low-profile CEO in Christopher Missling, a small dedicated team, and very loyal investors. Certainly, there have been some missteps along the way, but Missling has delivered a drug that can lead to improvement in some early Alzheimer's disease patients and which may help to treat at least a few other neurological diseases and conditions as well.

        So far, the AVXL news has not been widely embraced in a field that has been for years dominated by the amyloid hypothesis for Alzheimer's disease, but for some, at least, that could change once the current data is objectively reviewed and additional results are released. The temporary pullback in Anavex Life Sciences Corp. stock value may be reversed soon, if either or both of these occur. A positive FDA decision, though, would be the game changer.

        This article was written by
        Lane Simonian profile picture
        Lane Simonian
        2.24K Followers
        Retired history instructor. Alzheimer's disease researcher for the past decade.My goal is to give investors solid advice based on the mechanisms of action of Alzheimer's drugs. This advice is informed by a background in biology (conservation, ecology, evolution, environmental science, and biochemistry) and seventeen years of a very in depth review of the research on Alzheimer's disease.
        Show more

        Disclosure: I/we have no stock, option or similar derivative position in any of the companies mentioned, and no plans to initiate any such positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.
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        8
        • D Offline
          D Offline
          deleted-user
          wrote on sidst redigeret af
          #225

          Anavex Alzheimer's Association nævner ikke Anavex efter CTAD?

          Alzheimer's Association, der skulle forstille at være en organisation, der varetager AD patienternes interesser, nævner slet ikke Anavex i deres referat/konklusion for CTAD.
          De hylder dog Biogens Levcamemab, som en meget mulig løsning for Alzheimer.

          Alzheimer's Association lever hovedsaglig af sponsorater, heriblandt fra BP - på ca. 480 mill. $ årligt.

          Top 3 lønninger i Alzheimer's Association:

          1 Harry Johns $1,015,015
          2 Richard Hovland $650,856
          3 Robert Egge $574,617

          Til sammenligning får Missling 500.000 $!

          Kunne der måske være en "lille" sammenhæng mellem de selskaber de fremhæver og hvor de får pengene fra?
          Det er nok helt utænkeligt - især i US!
          Er bare glad for, at Anavex har kørt forsøgene unden for US og ikke er afhængig af FDA og US systemet!

          Andel shortede aktier steg fra ca. 10 mill. til ca. 12 mill. den 30. November 2022 - altså umiddelbar før CTAD!
          Ikke så sært, at kursen skulle presses ned - uanset resultaterne fra Anavex den 1. Dec!

          JP Morgan deltagelsen, kan have været signalet til shorterne, at de nu skal begynde at trække sig ud.
          Anavex stiller ikke op på JP Morgan uden de er 100 % klar med hele datapakken.
          De næste uger med flere nyheder fra Anavex, vil måske presse shorterne yderligere.

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          • SolsenS Offline
            SolsenS Offline
            Solsen
            wrote on sidst redigeret af
            #226

            Det viser jo blot, at vi skal forberede os på knaster i det fremtidige forløb.

            Mange teorier om hvordan Anavex skal at komme gennem skjoldet i fda. Det bliver en vanskelig opgave.

            Jeg håber, at de to tidligere fda ansatte hos Anavex kan åbne nogle døre.

            Fda er heldigvis på hælene mht alzheimers og deres skandaløse godkendelse af Aduhelm. Mon ikke Lecanumab ligner Aduhelm så meget, at fortiden skræmmer fda fra at lave to fejl på stribe.

            Håber at Anavex kan få 50 mg armen i hus snart. Det er den der skal være sømmet, der gør, at fda ikke kan undslå sig.

            Anavex bør i min optik ikke vente for længe med at indgå partnerskab. Deres tempo alene kan godt bekymre.

            Siger fda flere fase 3 skal de også have partner på ellers er der mange år til at indikationen er i hus.

            Et stort US pharma (partner) der sender ansøgningen til fda tror jeg ville øge odds for at det glider gennem systemet.

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            • V Offline
              V Offline
              vestasfan
              wrote on sidst redigeret af
              #227

              Unmet medical need delen bør virkelig skubbe fremad hos relevante myndigheder. Data kan jo ikke bare sande til hele tiden, hvis det ene eller det andet hele tiden obstruere for fremskridt!

              Skidtet er tilsyneladende helt og aldeles ufarligt; Tjek ud for det. Så man kan rent faktisk tilbyde det uden at man bliver dødlige syg af det, (modsat konkurrenternes). FDA nævner selv i deres guidlines, (frit fra hukommelsen), at Unmet er et særligt fokus område fremover, og derfor vil barren også væren en anden, (læs lavere, for at få sat skub i forskningen). Spørgsmålet er ikke så meget godkendelses delen, spørgsmålet er, om fagpersoner herunder nøglepersoner rundt omkring på kloden vil anbefale deres respektive sundheds sytemer og patienterne et stof! Her taler foreløbige data for sig selv.

              De efterfølgende peer reviews i de videnskablige litteratur tidsskrifter, vil formentlig gør det helt klart hvad vi taler om. Husk det allervigtigste, udover, progression af lidelsen, er bivirkningsprofilen..

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              • F Offline
                F Offline
                Fandel
                wrote on sidst redigeret af
                #228

                Så sandt vestasfan...

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                • P Offline
                  P Offline
                  ProinvestorNEWS
                  wrote on sidst redigeret af
                  #229

                  Pharma- og biotekopdatering uge 50:

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                  • D Offline
                    D Offline
                    deleted-user
                    wrote on sidst redigeret af
                    #230

                    Anavex Nyansatte Timo Grimmer og 3 andre Podcast med CTAD.

                    En tyske podcast med 4 tyske professorer, heriblandt Timo Grimmer diskuterer den afsluttede CTAD konference.
                    Dvs. i de ca. 24 min. podcastet vare, så bruger de godt 21 min. alene på Biogen og Lecanemab. Her er de umiddelbar positiv over for resultaterne - de diskuterer dog de 2 dødsfald og nødvendigheden for monitering af patienter og måske en begrænsning til hvilke patienter, der kan få Lecanemab. Men især den ene så frem til at det kom på markedet på et tidspunkt. Der blev også diskuteret, om de forventede måske 6 mdr. Lecanemab evt. kan forlænge sygdomsforløbet, står mål med de økonomiske omkostninger og de menneskelig omkostninger ved selve behandlingsmetoden og skanninger.

                    ENSTE andet selskab der nævnes og omtales positivt er Anavex, hvor Timo Grimmer igen fortæller, at 2-73 har en rigtig god bivirkningsprofil og at patienterne bliver mindre demente i løbet af de 48 uger - samtidig bemærkes der også, at medicinering via tabletform er at foretrække ifht. Biogens intravenøse behandling og løbende skanning af hjernen.

                    Det undrer mig dog, at de andre professorer ikke havde noget at sige til (læs - faldt på halen over), at patienterne modsat hos Biogen blev bedre?
                    Der var ikke nogen "løftet øjenbryn" over, at AD patienterne blev bedre - i stedet for blev der igen snakket om Biogen og muligheden for at få Lecanemab på markedet i Europa?
                    Jeg tænkte bare - MANDEN SAGDE LIGE AT PATIENTERNE BLEV BEDRE OG UDEN BIVIRKNINGER, OG I NÆSTE SÆTNING SÅ SNAKKEDE DE GUDHJÆLPENE OM AT FÅ LECANEMAB PÅ MARKEDET! - HALLO ER DER NOGEN HJEMME???

                    Timo Grimmer er jo efterfølgende blevet ansat af Anavex (som 5. eller 6. tysker i teamet) og alt andet lige, så er det positivt, at Anavex som de eneste udover Biogen klarede at blive omtalt på denne ROCHE podcast.
                    Meget interessant at man lige i ROCHE regi omtaler Anavex, da de jo lige har stoppet deres fedtfjernelsesprogram i AD og nu siger at de forsat ønsker at være aktiv i Alzheimer, men nu via. en partner, som har anden forskning/platform i Alzheimer!

                    https://www.portal.roche.de/aktuelles/roche-podcasts/nervennahrung/podcast-ctad-2022-neuro-news-aus-san-francisco-highlights.html

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                    • F Offline
                      F Offline
                      Fandel
                      wrote on sidst redigeret af
                      #231

                      Tak tak tak Tasso1...

                      1 Reply Last reply
                      2
                      • O Offline
                        O Offline
                        otul
                        wrote on sidst redigeret af
                        #232

                        Anavex-Når resultaterne , som Anavex har opnået med 2-73, er så gode som div. forskere og professorer inden for området giver udtryk for, burde Anavex så ikke gå mere aggressiv ud i diverse medier for at formidle denne viden ud til almindelige borgere ?! Organisationer som burde varetage syge borgers interesse, samt FDA,hænger øjensynligt da noget i bremsen

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                        4
                        • D Offline
                          D Offline
                          deleted-user
                          wrote on sidst redigeret af
                          #233

                          Anavex otul - forventer også at Anavex bliver mere aktive med at få budskabet ud, når de har færdigbehandlet de samlede data og gjort dem mere entydige og sværere at modargumenterer af markedet og især af dem, som har stor interesse i, at Anavex ikke får succes.
                          40 min. grundig gennemgang på JP Morgan den 12. Januar 2023, kan blive startskuddet til at få banket de gode resultater ind i omgivelserne.
                          Anavex er helt klar over, at enhver usikkerhed eller tvivl i de samlede data vil blive brugt mod dem - de skal derfor være helt skudsikre.
                          Som vi ser nu, tør ingen større analytiker end ikke stikke kursmål ud - ville være en fin start, hvis JP Morgan lagde for, når det nu er dem selv, der har inviteret Anavex til deres egen kongres. ( man kan kun blive inviteret med på JP Morgan)
                          Får vi som lovet resultaterne fra PDD OLE her lige om lidt, kan disse være med til at underbygge AD data, pga. sammenfaldet i indikationerne og virkemekanismen.

                          En partneraftale med f.eks østriske ROCHE, ville passe rigtig fint sammen. Bare sproget og måske tilgange/mentaliteten ville de 5-6 tysker i ledelsen hos Anavex, måske kunne få et bedre konstruktivt samarbejde med en østriske ledelse, end med f.eks et US selskab.
                          Dette udover, at ROCHE netop lige mangler en partner med en ny Alzheimer platform, da de som tidligere skrevet, jo har skrottet deres egen fedtfjernelsestilgang.

                          Pga. skattemæssig forhold, behøver der for min skyld ikke at komme alt for meget positivt kursmæssig før den 31. december - tror dog "desværre" ikke, at vi kan undgå dette, da Anavex jo har lovet flere milepæle i indeværende år.

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                          8
                          • SolsenS Offline
                            SolsenS Offline
                            Solsen
                            wrote on sidst redigeret af
                            #234

                            Anavex og Blarcamesine nævnt i "Nature"

                            https://www.nature.com/articles/d41586-022-04444-3?fbclid=IwAR3iwkjGdygULNmxGwJfN1ghZ8kKRgojToyBw06uuHCIpNLU83h91V6UyP8

                            Biogens Lecanumab sætter der spørgsmålstegn ved ...

                            Det rette perspektiv kommer måske frem over tid.

                            1 Reply Last reply
                            9
                            • D Offline
                              D Offline
                              deleted-user
                              wrote on sidst redigeret af
                              #235

                              Anavex "Nature" er åbenbart ikke i lommen på BP.

                              Godt fundet Solsen:)

                              Alzheimer's drugs
                              In early January, US regulators will announce whether a drug that slowed down the rate of cognitive decline in a robust clinical trial1 can become available to people with Alzheimer's disease. Developed by the pharmaceutical company Eisai and the biotechnology firm Biogen, lecanemab is a monoclonal antibody that clears amyloid-β protein that builds up in the brain. The clinical trial included 1,795 people with early-stage Alzheimer's and showed that lecanemab slowed mental decline by 27% compared with a placebo. However, some scientists think this is only a modest benefit and others are concerned about the safety of the drug.

                              Another Alzheimer's drug, called blarcamesine - developed by Anavex Life Sciences in New York City - will continue to make its way through clinical trials. Blarcamesine activates a protein that improves the stability of neurons and their ability to connect with each other.

                              Anavex har tidligere været omtalt positiv i "Nature", vedr. Fragile X:

                              www.nature.com/articles/s41598-021-94079-7

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                              6
                              • D Offline
                                D Offline
                                deleted-user
                                wrote on sidst redigeret af
                                #236

                                Anavex Et tætpakket program i resten af 2022.

                                Dette når de næppe - det primære er, at de bruger al krudtet på at få analyseret og præsenteret hele datapakken fra AD fase 2/3.

                                Skulle vi nå at få gode PDD OLE data og måske at RETT er afsluttet, så må resten godt vente til 2023 - iflg. IR burde vi få min. PDD OLE.
                                8 handelsdage tilbage og spørgsmålet er hvor aktive er man mellem jul og nytår - kun den 26. dec. er der lukket og fredage er sjælden brugt til nyheder - så meget taler for nyheder en af de næste 3 dage.
                                https://www.nasdaqtrader.com/Trader.aspx?id=Calendar

                                > Data of 48-week OLE PDD Phase 2 study - expected by end 2022
                                > EXCELLENCE completion: Potentially pivotal Phase 2/3 pediatric RTT clinical trial - expected by end 2022
                                > Initiation of ANAVEX®2-73 imaging-focused Parkinson's disease clinical trial - expected 2022
                                > Initiation of potentially pivotal ANAVEX®2-73 Phase 2/3 Fragile X clinical trial - expected 2022
                                > Initiation of potentially pivotal ANAVEX®2-73 Phase 2/3 clinical trial for the treatment of a new, rare disease indication - expected 2022
                                > Initiation of ANAVEX®3-71 Phase 2 clinical trial for FTD, schizophrenias and Alzheimer's disease - expected 2022

                                1 Reply Last reply
                                5
                                • SolsenS Offline
                                  SolsenS Offline
                                  Solsen
                                  wrote on sidst redigeret af
                                  #237

                                  Anavex...En anmodning der er helt i skoven.

                                  Link Preview Image
                                  Alzheimer’s Association Calls on CMS to Reverse Its Decision to Severely Limit Access to FDA-Approve

                                  Alzheimer’s Association Calls on CMS to Reverse Its Decision to Severely Limit Access to FDA-Approved Alzheimer’s Disease Treatments

                                  favicon

                                  Alzheimer’s Association (www.alz.org)

                                  Elendige monoklonal tilgang til amylin fjernelse er ikke til patienternes beste. Money talks af værste skuffe.

                                  Come on Anavex!

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                                  5
                                  • SolsenS Offline
                                    SolsenS Offline
                                    Solsen
                                    wrote on sidst redigeret af
                                    #238

                                    Anavex...Ingen tvivl om at der er megen fokus på AD mv

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                                    Congress Prioritizes Addressing Alzheimer’s and Dementia

                                    Key provisions of the ENACT Act, strengthened FDA accelerated approval pathway, a $226 million increase for research and $33 million to fund Alzheimer’s public health in FY23 budget bill.

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                                    Alzheimer’s Association (www.alz.org)

                                    Come on Anavex

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                                      vestasfan
                                      wrote on sidst redigeret af
                                      #239

                                      Først "Nature" nu "Forbes"; https://www.forbes.com/sites/forbescommunicationscouncil/2022/12/20/how-artificial-intelligence-is-transforming-biopharma-and-what-it-means-for-marketers/?sh=1e0422a14402&fbclid=IwAR0ACCPjR2BFn-pzblktvgmvKY56MwX4GjpCGwZbHYSGFUNwotjx4qDtrh0

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                                        deleted-user
                                        wrote on sidst redigeret af
                                        #240

                                        Anavex Ja ringene spreder sig - men meget langsomt.

                                        Forbes:
                                        One company using a technology-driven approach to drug discovery is Anavex Life Sciences. Anavex is developing a drug to help Alzheimer's patients. The company used a precision medicine approach and recently announced positive results in its Phase 2B/3 clinical trial. The company leveraged Ariana Pharma's AI technology to illustrate the promising results of its drug.

                                        Når sponsoratet fra BP bare er stort nok til The Alzheimer's Association, så bliver de nok ved med at sige, at jorden er flad (fedtfjernelsestilgangen) - selvom Anavex med deres innovative tilgang og resultater har vist, at jorden faktisk er rund.

                                        Håber mere og mere på, at Anavex kører udenom FDA og US og først kommer på markedet i nogle af de lande, hvor de har kørt deres vigtigste forsøg.

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                                          deleted-user
                                          wrote on sidst redigeret af
                                          #241

                                          Anavex Meget positive World Financial Review!

                                          Fremtidens behandling af demens!

                                          Dejligt at stadig flere er begyndt at få øjnene op for den innovative videnskab der ligger til grund for Anavex`s platform.
                                          På et tidspunkt skal aktiekursen nok afspejle dette - en partneraftale eller en markedsgodkendelse/myndighedsudmelding i et eller andet, et eller andet sted i verden, vil få tingene til at eksploderer!!

                                          How Digital Innovation Is Changing Life Sciences and the Way We Treat Dementia

                                          Just a moment...

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                                          (worldfinancialreview.com)

                                          Dementia develops when nerve cells in the brain, the spinal cord, and its connecting tissues are damaged or lost. Nerve cell damage happens most often because of underlying diseases, such as Parkinson's or Alzheimer's. Despite scientific advances, once nerve cells have been damaged, they cannot be regenerated.

                                          With multiple functions in protecting nerve cells in the brain and the spinal cord, the sigma-1 receptor has emerged as one of the main targets in treating diseases like dementia. Those with dementia have been found to have a much lower volume of sigma-1 receptors. ANAVEX®2-73 binds to this receptor and increases its activity.
                                          Research and early clinical trials have been supported by the Michael J. Fox Foundation for Parkinson's Research. Since then, the drug successfully completed several stage-two trials that have shown that it can improve common symptoms of dementia.

                                          When envisioning the future of dementia treatment, trials of ANAVEX®2-73 suggest that society may be close to being able to effectively treat dementia conditions. Trials of this drug related to Parkinson's disease dementia showed improvements in movement- and non-movement-related symptoms of the disease.6 Scientists linked the improvement in symptoms to higher activity levels in the patients' sigma-1 receptors. Blood tests on trial participants also showed that the drug improved the function of genes that have been impaired in patients with Parkinson's, Alzheimer's, and other dementias.

                                          Scientists are on the brink of offering simple, yet powerful treatments to improve disorders of the brain and spinal cord. Anavex Life Sciences is an industry-leading biotechnology company that is dedicated to finding a successful treatment for conditions that impact the brain and spinal cord.

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