Anavex indsender ansøgning til EMA den 26. november 2024!!
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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 -
Anavex angivelig skulle journalnavnet komme frem, når skyggen fjernes.
The Journal of Prevention of Alzheimer's disease
(Udkommer i løbet af januar 2025)/production/original_597208598.png)
Audrey Gabelles præsentation.
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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
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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. -
Anavex Både Audrey Gabelle og Marwan Sabbagh er editor på JPAD.
https://www.jpreventionalzheimer.com/editorial-board.html
JPAD ligger som nr. 3 på top 10 af mest betydningsfulde Alzheimer journals.
https://www.rxcomms.com/blog/top-alzheimers-journalsSpekulation.
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? -
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.
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
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. -
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.
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EMA har accepteret ansøgningen
https://www.anavex.com/post/blarcamesine-receives-ema-filing-acceptance-for-treatment-of-alzheimer-s-disease -
Det CC var helt til grin.
Ved ikke hvad jeg skal mene omkring normal procedure. Man skulle jo mene, at Anavex var berrettiget til accelerated procedure.
Vi må læne os op ad sandsynligheden på ca 90% for approval, når man er kommet så langt i processen med EMA.
Næste spændende nyhed er peer review og OLE data.
Mon ikke shorterne kan holde skansen i år.
God jul herfra.
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