Anavex indsender ansøgning til EMA den 26. november 2024!!
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De har en ambition om at processen tager max. 30 dage, men det afhænger også af om en ansøgning opfylder alle krav og har alt info EMA skal have. Ellers kommer ansøgningen på clock stop, hvor EMA afventer svar fra ansøger, og det vil så ikke talles med i de 30 dage.
https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/obtaining-eu-marketing-authorisation-step-step
Lad os håbe på at Anavesøx har styr på det, og at vi får en god nyhed inden jul. -
Det som også er uklart for mig er, om ansøgen er kommet igennem Validation of the Application. For Missling fik tildelt option den 19.nov, nok der ansøgningen blev submitted, men først blev PR den 26.nov. Var det så den periode de har brugt på Validation. Hvis det er, så er ansøgningen allerede
accepteret og er kommet i godkendelsesprocessen, som vil tage op til 210 dage uden clock stop. -
TTKDK
Hvis ansøgningen er accepteret og de er i gang burde Blairmecasine så ikke figurere under denne liste som sidst er opdateret d 9 Dec. ?
https://www.ema.europa.eu/en/medicines/medicines-human-use-under-evaluation -
Gabelles præsentation fra sidste uge ligger på Stockwits på fransk. Har fået Chat GPT til at lave et resume på dansk.
Forfatter:
Pr. Audrey Gabelle, MD, PhD, fra CMRR, Neurologisk afdeling ved CHU og Université de Montpellier samt INSERM Institut des Neurosciences.Baggrund og Mekanisme
Alzheimers sygdom (AD) er en kompleks og heterogen neurodegenerativ lidelse med centrale mekanismer som ophobning af amyloid-beta (Aβ) og Tau-proteiner.
Blarcamésine (ANAVEX
2-73) er en lille molekylebehandling, der aktiverer SIGMAR1-receptoren. Dette forbedrer autophagien - en nøglemekanisme til at rydde fejlfoldede proteiner og reducere skader på celler.Kliniske Resultater
• Fase IIb/III-studie: Randomiseret, dobbeltblindet forsøg over 48 uger viste en klinisk relevant forbedring af kognitive funktioner målt med ADAS-Cog13 (36,3%-49,8% forbedring) og en reduktion i kognitiv tilbagegang målt med CDR-SB (27,6%-33,7%).
• Positive effekter blev især observeret hos patienter med den almindelige SIGMAR1 WT-genvariant.Biokemiske og Imaging-Resultater
• Signifikant forbedring af biomarkører relateret til Alzheimers sygdom, såsom amyloidforholdet (Aβ42/40).
• Reduktion i hjerneatrofi observeret på billeddannelse efter 48 uger.Sikkerhedsprofil
• God tolerabilitet med få bivirkninger (primært svimmelhed af mild/moderat karakter), som kunne håndteres med dosisjustering.
• Ingen alvorlige bivirkninger relateret til behandlingen.Konklusion
Blarcamésine (ANAVEX2-73) er en innovativ, oral behandling baseret på en lille molekyle, som forbedrer autophagien - en central mekanisme til fjernelse af ophobede og fejlfoldede proteiner - gennem aktivering af SIGMAR1-receptoren. Denne målretning af autophagien gør behandlingen relevant for en bred vifte af neurodegenerative sygdomme.De kliniske resultater viser, at Blarcamésine er effektiv til at bremse den kognitive tilbagegang hos patienter med tidligt stadie Alzheimers sygdom, især hos dem med SIGMAR1 WT-genvarianten. Behandlingen er godt tolereret med få bivirkninger og ingen alvorlige sikkerhedsproblemer. Kombinationen af oral administration, klinisk effekt og en stærk sikkerhedsprofil gør Blarcamésine til en lovende mulighed for behandling af patienter med Alzheimers sygdom på et tidligt stadie.
Ansøgningen til Det Europæiske Lægemiddelagentur (EMA) blev indsendt i slutningen af november 2024, hvilket markerer et vigtigt skridt mod bredere tilgængelighed af denne behandling.
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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- 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.
AVXL: Anavex Life Sciences Corp Latest Stock Price, Analysis, News and Trading Ideas
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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.
www.elsevier.com (www.elsevier.com)
- Is Elsevier publication good?
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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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