Anavex Dialog med EMA om godkendelse af 2-73 i Alzheimer!!!
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Hej TTTDK.
Ang. dit spørgsmål, hvor AVXL er i processen, så har de fremsendt en ansøgning d. 20.11.23 og modtaget svar fra EMA d. 19.2.23, at man er villig til at undersøge om, man vil kunne tildele dem en alm. genere (ikke fast speed) markedsføringsgodkendelse. (se link)
Iflg. timelinien skulle man således være ca. 3 mdr. henne i processen, der regnes at tage ca. 12 mdr.
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Hvis nogen ikke fik hele rapporten læst, så er den her.
Anavex Life Sciences Corp. (NASDAQ:AVXL) Q1 2024 Earnings Call Transcript February 7, 2024
Anavex Life Sciences Corp. beats earnings expectations. Reported EPS is $-0.0001, expectations were $-0.14. AVXL isn't one of the 30 most popular stocks among hedge funds at the end of the third quarter (see the details here).
Operator: Good morning. Welcome to the Anavex Life Sciences Fiscal 2024 First Quarter Conference Call. My name is Clint Tomlinson and I will be your host for today's call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. And during this session, if you would like to ask a question, please use the Q&A box or raise your hand. Please note during this conference - this conference is being recorded. The call will be available for replay on Anavex's website at www.anavex.com. With us today is Dr. Christopher Missling, President and Chief Executive Officer; and Sandra Boenisch, Principal Financial Officer. Before we begin, please note that during this conference call, the company will make some projections and forward-looking statements.
These statements are only predictions based on current information and expectations and involve the number of risks and uncertainties. We encourage you to review the company's filings with the SEC. This includes without limitation the company's forms 10-K and 10-Q, which identify the specific factors that may cause actuary results or events to differ materially from those described in these forward-looking statements. These factors may include without limitation risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, and maintenance of intellectual property rights. And with that, I would like to turn the call over to Dr. Missling.
Christopher Missling: Thank you, Clint, and good morning, everyone. Thank you for being with us today to review our most recently reported financial results and to provide our quarterly business update. We are poised for a very exciting year for Anavex. In December, the Committee for Medicinal Products for Human Use within the European Medicines Agency agreed to the oral blarcamesine for Alzheimer disease is eligible for submission of an application for a Union Marketing Authorisation in the EU under the European Medicines Agency centralised procedure. The market authorization would allow direct market access throughout the European Union for oral blarcamesine for the treatment of Alzheimer disease. We are actively engaged on this process and aiming to submit the market authorization application as early as possible in 2024.
Full data from the blarcamesine in Alzheimer's disease Phase 2/3 randomized clinical trial is forthcoming and will be published in an upcoming peer-reviewed journal. Also, we'd like to mention that the respective open-label extension 96-week trial ATTENTION-AD is ongoing. Top line data from ANAVEX2-73-RS-003 Phase 2/3 EXCELLENCE pediatric clinical trial was announced last month. We intend to further assess the results and discuss with the regulatory authorities next steps. A high enrollment rate into the OLE open-label extension of over 91%, as well as the high level of requests for the Compassionate Use Program of 93%, provide solid numerical evidence for the positive real world evidence reported by patients and their caregivers with Rett syndrome under Compassionate Use Authorization.
Previously, we announced the first entire clinical gene pathway data from the ANAVEX2-73-RS-002 AVATAR Rett syndrome trial. We believe that this is the first time a whole genome exome analysis comparing drug and placebo in patients with Rett syndrome was performed, and we believe the results confirm that Rett syndrome is indeed a neurodevelopmental disorder with a key metabolic component, which can be addressed with therapeutic intervention and is likely relevant for other neurodevelopmental diseases as well. Related to ANAVEX3-71, our second clinical small molecule, we were pleased to announce the initiation of the U.S. FDA cleared placebo-controlled Phase 2 trial of ANAVEX3-71 for the treatment of schizophrenia, which is expected to begin in the second quarter of calendar 2024.
Regarding the Parkinson disease program, we are in preparation to initiate the ANAVEX2-73 imaging-focused trial and the ANAVEX2-73 Phase 2b/3 six months trial. For Fragile X, we believe new disease specific translatable and objective biomarker data generated recently with ANAVEX2-73 should be strengthening the support for the initiation of the potentially pivotal ANAVEX2-73 Phase 2/3 clinical trial in Fragile X. Related to a new rare disease, we are also preparation to initiate a potentially pivotal ANAVEX2-73 Phase 2/3 clinical trial. We are also expecting further peer-reviewed clinical publications involving ANAVEX2-73 and ANAVEX3-71. Last month, we announced a new peer-reviewed publication in clinical pharmacology and drug development, findings from ANAVEX3-71, first in human study, which are key achieved its safety objectives.
Spørgsmålene fra diverse er ikke med.
Mvh
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Vores ven MayoMobile har fundet et link, der kan berolige de der synes peer review artiklen lader vente på sig.
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"This cross-sectional analysis of clinical trials published in 2015 in 6 journals with a high impact factor found that by the time of publication, the median data age was nearly 3 years. The median publication time was more than 1.2 years, with 18.5% of trials taking 2 or more years to be published."
Potentielt lige på trapperne, ud fra medianen. 1 til 5 for at vi skal vente 12 mdr. eller mere.. det må gå som det går.
Værdien er banket så meget i kælderen, at det kun kan gå fra ringe til rigtig ringe efterhånden, hvis udfaldet ikke er som vi håber.
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List søndagslæsning om "cortical gray matter"
Let tilgængelig:
https://news.uthscsa.edu/thinning-of-brain-region-may-signal-dementia-risk-5-10-years-before-symptoms-2/Videnskablig artikel:
https://alz-journals.onlinelibrary.wiley.com/doi/10.1002/alz.13600MayoMobile:
https://www.sotcanalytics.com/archive-2023/brain-preservationNæppe megen tvivl om, at bevaring af hjernemassen er afgørende for at undgå demens og end og tidlig død.
Blarcamesine bevarer hjernemassen bedre en placebo med en p værdi på 0,0005. Derfor håb om, at bl.a demens kan afhjælpes og en livstidsforlængelse opnås.
Fra Anavex's meddelelse i oktober 2023:
"In addition, validated biomarkers of amyloid beta pathology, plasma Aβ42/40 ratio increased significantly (P = 0.048), demonstrating strong anti-amyloid effects of blarcamesine in Alzheimer's disease patients, while MRI revealed significant reduction in brain volume loss, including whole brain (P = 0.0005), comparing treatment to placebo" https://www.anavex.com/post/anavex-sphase2b-3trialofblarcamesine-anavex-2-73-inpatientswithalzheimer-sdiseaseGlæder mig til peer review artiklen
God søndag.
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Der sker noget hele tiden.
Nu er der fremkommet en artikel i "Nature" bag betalingsvæg omkring, at en blodprøve kan afsløre risiko for demens 15 år før det bliver aktuelt.
Her er en tilgængelig artikel med gengivelse af resultaterne.
https://medicalxpress.com/news/2024-02-protein-biomarkers-dementia-years-diagnosis.htmlBlodprøve er langt billigere og lettere end MCI scanningsbilleder.
Vigtige landvindinger, idet tidlig behandling er vigtig. Og husk Anavex påstår at tidlig behandling vil have præventiv virkning.
Shortandelen sænket ubetydelig https://www.nasdaq.com/market-activity/stocks/avxl/short-interest
Anavex med prof. Grimmer har et indlæg om resultaterne fra AD forsøget på konference i marts https://adpd.kenes.com/
Lad os håbe, at raketten og shorterne bliver brændt af senest på det tidspunkt.
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Trainguy1 har på Stockwits posted et skema omkring tidsforløb fra start af forsøg til hhv topline data, udgivelse af peer review artikel og accelerated approval for konkurrerende antistoffer og Blarcamesine.
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Trainguy1 (@Trainguy1) | Stocktwits
$AVXL I was asked recently how long does it take to publish a peer reviewed article after submission to a journal. I decided to look at times consumed by Eisai/Biogen following their AD drug topline readouts to publish full data articles and to obtain accelerated approval. I then applied those times to Blarcamesine for AD. The table below shows comparable finish dates for Blarcamesine. The big question is: Can Anavex match these timeframes?
Stocktwits (stocktwits.com)
Endnu er der ikke grund til frustration over det manglende peer review.
Af skemaet fremgå, at godkendelse kan ske hurtigt efter topline data er ude - men det er nok forbeholdt de store pharma i US
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Trainguy er en af de dygtige skribenter der.
Ihub er helt håbløs nu, gider ikke at læse om deres skænderier.
Ja hvis Anavex fik en store partner ind nu ville det værre helt fantastisk, de har FDA's øre.
Lad os håbe at de har gang i nogle forhandlinger med en partner eller 2. -
I onsdag deltog FDA chefen i en seance hos National Press Club. Her nævnte han bla LLY Donanemab i positive vendinger, så det lyder ret sandsynligt der kommer en godkendelse lige rundt om hjørnet.
FDA Commissioner Rob Califf took the podium Wednesday afternoon at the National Press Club, offering up more warnings about misinformation leading to declining vaccine uptake, and his usual quips about declining life expectancy.
Later in the hour-long conversation, on a question on Biogen's Aduhelm, the first Alzheimer's drug that won accelerated approval in 2021 and has recently been offloaded by Biogen, Califf admitted it was a "creative regulatory decision."
But he added that there are now two drugs - presumably Biogen and Eisai's fully approved Leqembi (lecanemab) and Lilly's likely soon-to-be approved donanemab - "that have met the full criteria" for approval. But he qualified that statement, adding, "Well, one has met the full criteria and one is under review, but the published evidence looks good."
Men en ting der også lige slog mig. Kan se der tales om årlig priser på $20-30.000 per patient.
Det pris niveau gør at de af flere årsager, skal håbe på novo fejler deres 2 store AD forsøg. 2 forsøg der med hver 1800 patienter på Rybelsus 14mg, der rapportere data 2. halvår 2025.
For modsat ozempic/Wegovy, hvor Novo ændrede dosis niveau på wegovy vs Ozempic, og dermed har gjort det muligt at tage 30% mere for wegovy, så er AD forsøgene med Rybelsus præcis samme 14mg dosis som til T2D. Det betyder prisen også vil blive den samme. Altså ca $950 per mdr.
Med den prisfastsættelse, så gælder det om at håbe den enten fejler fase 3 forsøgene eller Donanemab og 2-73 giver bedre resultater. Ellers tages der en del af markedsværdien af med en årlig pris i niveau $1.000-10,300
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De havde emnet oppe i News, der blev spurgt til om man ville kende svaret, nu der ikke var nogen behandling tilgænglig !
Ja ville men kende svaret? og resultatet var ikke 100% men 80% for at du havde risikoen, altså ikke sikkert du nogle sinde ville få sygdommen, selv om du lå i risikofeltet.
Mvh
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