Anavex indsender ansøgning til EMA den 26. november 2024!!
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Eller partnerskab.... Det er absolut relevant at dele i denne tråd. Mayomobile er et fyrtårn ift. Anavex' videnskab og er et vigtigt bekendskab som invester i AVXL.
Citat fra SOTC Analytics (Jesse Silveira/Mayomobile: " We propose that Anavex 3-71 and CT1812 would likely make an extremely potent Alzheimer's treatment."
SOTC Analytics (Mayo dækker Anavex og Cognition Therapeutics) https://www.sotcanalytics.com/archive-2024/cognition-therapeutics-cgtx
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Ikke meget for den siver under lav volume flere børsdage i træk, har dog alligevel taget et sats i 9.3 muligt et sats i 8.3$ havde de været et bedre sats...
Der skal også lidt held til, ingen rammer top og bund alligevel, så vi prøver.Ingen anbefaling
Mvh
Torben
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Anavex Trader17 - Missling udtalte på JP Morgan, at man ville informerer om status på kommende forsøg i Parkinson i slutningen af januar mdr. (sidste dag i dag)
Opdatering/data fra fase 2b forsøget med 3-71 i Skizofreni kommer først i løbet af 1. halvår 2025.
Tænker måske at dette kan trække lidt længere ud, da han samtidig oplyst, at man havde øget antallet af patienter for at styrke forsøget. -
Anavex og Alzheimer Europe.
(TTTav66 - ST)
https://www.alzheimer-europe.org/sites/default/files/2025-02/2025-01_alzheimer_europe_newsletter.pdfI Alzheimer Europes januarudgave omtales resultaterne fra AD fase 2/3 forsøget og accepten fra EMA af ansøgningen. (Side 16)
Her fremgår det også, at Anavex og CEOen fra Alzheimer Europe har haft et møde om et evt. fremtidig samarbejde i 2025. (Side 7)
Har en forventning om annoncering af Q1 rapport i dag.
Den lovede opdatering på status på kommende forsøg i Parkinson må også være lige på trapperne - måske vælger Anavex at lade dette indgå i kvartalsrapporten.
Q1 skal afholdes inden for den næste uges tid.
(Q1 2025 er kvartalet 1. okt. - 31. dec. 2024)I øvrigt påfaldende, at Missling i stigende grad nu bruger LinkedIn, som foretrukne kommunikationsform.
Tidligere kunne der gå måneder mellem “livstegn” fra selskabet.The rising cost of drug development in healthcare is raising crucial questions: | Christopher Missling, PhD
The rising cost of drug development in healthcare is raising crucial questions: → Are life-saving treatments becoming unaffordable for most? → Are we prioritizing innovation over accessibility? As costs continue to rise, pharmaceutical companies face increasing pressure to price medications higher to recover development costs. This trend leaves many patients—especially those without adequate insurance—at risk of not affording necessary treatments. But there’s more to the story. Innovation, especially in complex diseases like cancer, requires significant investment. Regulatory processes ensure safety and efficacy, but they also contribute to rising prices. So, how do we ensure both progress and accessibility? ✔️ Innovation is essential: Breakthrough treatments require investment, but the public should benefit. ✔️ Transparency and fairness: Healthcare costs shouldn’t leave essential treatments out of reach. ✔️ Policy change is critical: We need to find a balance that allows for innovation while ensuring accessibility for all. What are your thoughts on balancing the cost of drug development with patient accessibility? Let’s discuss! | 33 comments on LinkedIn
LinkedIn (www.linkedin.com)
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Ganske interessant det her.
Missling deltager på en thailandsk sigma-1 konference d. 21 februar. Her har en af de helt store debattører i en af Anavex Facebook-grupperne, Kevin Ameling, fundet frem til at et andet life science selskab, Prilenia, også er deltagende.
Det interessante ved Prilenia er at de i september 2024 sendte deres sigma-1 kandidat, Pridopidine, ind til godkendelse for Huntingtons Disease hos EMA.
Dermed har vi formentlig til sommer en indikation af om hvor stor pålidelighed som EMA generelt har til sigma-1 mekanismen.
"Pridopidine (45 mg twice daily) is an oral, highly selective and potent investigational S1R agonist that has exhibited a safety and tolerability profile similar to placebo in clinical studies to date. The current safety dataset includes approximately 1,700 patients who have been on pridopidine for up to seven years."
…
“Prilenia holds Orphan Drug designation for pridopidine in HD and ALS in the U.S. and EU. In addition, pridopidine has received Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of HD.”
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Anavex Life Sciences to Announce Fiscal 2025 First Quarter Financial Results on Wednesday, February 12, 2025
Anavex Life Sciences to Announce Fiscal 2025 First Quarter Financial Results on Wednesday, February 12, 2025 | Anavex Life Sciences
Webcast and Conference Call To be Held Wednesday, February 12, 2025, 8:30 am ET NEW YORK – February 5, 2025 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, […]
Anavex Life Sciences (www.anavex.com)
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Evt. Lecanemab godkendelsen i Europa sendt retur til CHMP:
"In November 2024, a positive opinion was received from the Committee for Medicinal Products for Human Use (CHMP) recommending approval of lecanemab.1 As part of its decision-making process, the European Commission (EC) has asked the CHMP to consider information on the safety of lecanemab that became available after the adoption of the CHMP opinion in November 2024 and whether this may require an update of the opinion,
and to consider whether the wording of the risk minimization measures in the opinion is clear enough to ensure correct implementation. These will be discussed at the CHMP meeting in February 2025.https://investors.biogen.com/node/28771/pdf
Flere SAE er dukket op i analyser af behandlede pts.
Drop lortet og godkend Blarcamesine
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Det er rigtig godt fundet - 7 år med tolerabilitet svarende til placebo er meget betrykkende. Desuden viser deres forløb (fast track) med FDA at godkendelseskravet er lavere når der ikke eksisterer effektive alternativer og bivirkningerne er så få eller helt fraværende
Tak Milto -
Det blev smidt 200k ind i sidste minut, kun for at holde os under 9$ MM styre showet, ufatteligt der ikke bare spilles på stigende kurs, i stedet for den åndssvage kamp for at holde den i nedtrend..
Jeg fatter det ikke...
Desværre rigtig mange dage endnu, hvor usikkerheden stadigvæk er en fakta..
Vel kun en partner aftale herfra og mellem EMA, der kan flytte rigtig på noget, og selvfølgelig en squeeze der kan komme ud af den blå luft..Mvh
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Kunne det tænkes at en godkendelse, kunne bruge til forhandle en god aftale med en af de store farma selskaber, da de kunne få et forspring over for de andre farma selskaber !
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Altså efter godkendelse
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