Anavex HISTORISKE OG BANEBRYDENDE RESULTATER I ALZHEIMER!!!
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Vores ven Lane Simonian fra Seekingalpha har lavet endnu et positivt skriveri om Anavex:
Anavex: Drug Treatments For Early Alzheimer's Disease
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Indeed, the poll options were put in by other FB members and then voted upon. I haven't mentioned to the group yet but I do not find it particularly beneficial to try to compare in-depth at this stage. Need more data to make a high-confidence product.
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En lidt mærkelig artikel fra en der kalder sig selv Dr gummisko (ha-ha) men er nu ikke helt uenig i det han skriver.
Getting Back to You on Anavex, Cassava, metformin and more - Stock Gumshoe
Doc Gumshoe follows up on reader questions
Stock Gumshoe (www.stockgumshoe.com)
Han skriver blandt andet i hans konklusion:
On the Alzheimer's front, Anavex claimed that they had new data on their drug, stating that it reduced clinical decline in patients with mild cognitive impairment. They said that 84% of subjects who received Anavex-2-73 / blarcamesine "demonstrated visible improvement" compared with placebo patients. But they didn't say how much these persons improved - just that they had improved.
Anavex is clearly trying to boost their share price with these announcements, and the reaction from several respected pharmaceutical news sites has been sharply critical. STAT called Anavex's announcement a "spin job," and Fierce Biotech threw a "rotten tomato" at Anavex.
To make my own position clear: it seems clear that Anavex-2-73 / blarcamesine has definite merit regarding Rett syndrome, and I should think that would be recognized by the FDA, especially with regard to that disease, for which there is no available treatment. But Anavex is not, and from the economic perspective, cannot be content with that. They want FDA approval as a treatment of some kind for Alzheimer's. But at present, they aren't doing themselves any favors by fiddling with their clinical trials. The problems aren't with the drug itself, but with the company.
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Yderligere skriver gummiskoen om SAVA:
I hope you're aware that I'm not putting Anavex and Cassava in the same boat. Anavex has a potentially valuable candidate drug and may just be getting in its own way by over-hyping it. Cassava's candidate drug is a highly doubtful prospect to start with. My guess is that the insiders would like to boost the stock price to where it was, say a year-and-a-half ago, when it was triple the present price ... and then get out! That's just a guess, of course.
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Der er flere artikler ude pt. https://techbullion.com/is-early-alzheimers-treatable-new-clinical-trials-suggest-maybe/
Det vel lidt af det sammen hentet fra samme historieskriver
Mvh
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Anavex Omtale - Positiv på 2-73 og negativ på fedtfjernelsestilgangen.
However, new clinical trials offer hope for effective treatment of early Alzheimer's.
A New Approach to the Treatment of Early Alzheimer's Shows Great Promise
Is Early Alzheimer's Treatable? New Clinical Trials Suggest, Maybe
Alzheimer's is the most common form of dementia. It's a slow-progressing disease, and its mechanisms are poorly understood, despite well over a century's awareness of the condition. Treatments are available for Alzheimer's, but a majority of them treat the symptoms, rather than altering the disease itself.
TechBullion (techbullion.com)
Tror vedkommende har læst "The Science Times", men altid godt med lidt omtale i den lange ventetid!
Havde jeg været CEO i Anavex, havde jeg nok lukket de pågældende ansatte ind et lukket rum og med servering af mad og drikke gennem en lille lem, indtil de havde færdiggjort den endelig rapport for AD fase 2/3 forsøget:)
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Anavex Motley Foll positiv - nu står verden ikke længere!
3 Biotech Stocks Under $15 Worth a Second Look in 2023 | The Motley Fool
All three stocks have promising therapies that could drive revenue in the coming years.
The Motley Fool (www.fool.com)
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Det giver åbentbart god mening at køre sine forsøg uden for US. Der er 60% besparelse på den post, og nok ikke lige så indspiste som FDA ... Australien https://www.australianclinicaltrials.gov.au/why-conduct-clinical-trial-australia
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Anavex Helt enig BioShare, men Motley Fool har ellers notorisk været negativ på Anavex og tror faktisk, at de har en hel del følger.
Har ofte haft det indtryk/mistanke, at Motley Fool har været en slags "shortindikator", forstået på den måde, at negative omtale fra MF ofte faldt sammen med et efterfølgende pres på Anavex`s aktiekurs.
Omvendt kunne derfor selv en tyndbenet positiv artikel, signalerer et tegn på at påbegynde inddækning af short positioner?
Men der er nok ingen sammenhæng overhovedet - dette ville aldrig forekomme i US:)
Stoler efterhånden så lidt på US markedet, at man med tiden er kritisk for næsten alt, hvad der kommer af udmeldinger fra div. såkaldte analytikere mm.Så derfor gerne Anavex indlede en dialog med EMA eller Australien - i US kræver det næsten nødvendigvis en BP som partner for at blive anerkendt!
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" Så derfor gerne Anavex indlede en dialog med EMA eller Australien - i US kræver det næsten nødvendigvis en BP som partner for at blive anerkendt!"
Missling har vist kapital til at fedte rundt i 4 til 5 år, så det bliver vel tidligst først i 2025. Spøg til side, jeg er enig i forhåbningen.
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Kursen er ligegyldig (for mig) med mindre man er daytrader.
Data afgør fremtiden og de kommer vel indenfor de næste måneder.
Her er lidt spændende læsning omkring Ariana og Anavex:
#pharma #lifesciences #drugdevelopment #artificialintelligence #ai #neurology #alzheimers #parkinsons | Ariana Pharma
A review published last week by Harald Hampel, MD, PhD, MSc and Team mirrors the development over the past decade of personalized neurology for Alzheimer's and other neurological diseases at Ariana Pharma. Thanks for sharing this great work! Working together with Anavex Life Sciences, Ariana Pharma has identified variant and gene expression patient selection, pharmacodynamic, and surrogate biomarkers for ANAVEX2-73 in Alzheimer's, Parkinson's and Rett neurological diseases. These biomarkers have had a major impact on the other requirements for personalized neurology identified in this paper. https://lnkd.in/deiS-4XS #pharma #lifesciences #drugdevelopment #artificialintelligence #ai #neurology #alzheimers #parkinsons
LinkedIn (www.linkedin.com)
Ved læsning af artiklen i Neurosciences får man det indtryk, at man også benytter Ariane til at vælge deltagerne i forsøgene. Det kan forklare, hvorfor det tager tid at rekruttere til bl.a. Excellence. Fornuftigt at de rekrutterede pts er repræsentative for populationen og antallet er dækkende til analyse af div varianter, man vil analysere selvstændigt.
Glæder mig til at se, hvad der kommer ud af analyserne. Se bl.a. indlæggene under det der linkes til. Cancerforsøg, hvor der er fundet en sammenhæng mellem effekt og nogle biomarkører.
Fremgangsmåden og de analyser der kommer ud af metoden giver efter min vurdering langt større chance for en approval i mindst en delmængde af patienterne. De patienter behandling ikke virker på spilder ikke deres tid og de der betaler spilder ikke deres penge. Win win.
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Anavex Lidt Seeking Alpha og en You tube video med 2-73 i Parkinson.
Enig Solsen - kun data tæller i sidste ende!
Har kun taget en kopi af det der vedr. Anavex, hvis linket skulle lukke for fuld adgang igen.
Anavex: Drug Treatments For Early Alzheimer's Disease
Jan. 17, 2023 5:10 PM ETAnavex Life Sciences Corp. (AVXL)BIIB, ESALF, ESALY, LLY28 Comments
29 Likes
Lane Simonian profile picture
Lane Simonian
2.26K FollowersFollow
SummaryAnavex 2-73/blarcamesine at high concentrations in early Alzheimer's disease leads to improvements in cognition and activities of daily living that are largely sustained for 148 weeks in most individuals.
Alzheon's ALZ-801 reduces cognitive decline in ApoE4 carriers by about the same amount as Eisai and Biogen's Leqembi and Aduhelm, but without the risks of brain bleeds and swelling.
Cyclo Therapeutics Trappsol Cyclo by reducing cholesterol levels in the brain inhibits the processes that lead to the onset and at least the early progression of Alzheimer's disease.
These three drug candidates offer the best hope for the treatment of early Alzheimer's disease. In many cases, they may be more effective when used in combination.Anavex Life Sciences Anavex 2-73/blarcamesine
Anavex Life Sciences (NASDAQ:AVXL) Anavex 2-73/blarcamesine is a sigma-1 receptor agonist which inhibits the release of intracellular calcium into the cytoplasm in part by transferring it to the mitochondria. Aricept/donepezil is also a sigma-1 receptor agonist, although it may preferentially bind to acetylcholinesterases. In any case, at high concentrations Anavex 2-73 vastly outperforms not only a placebo at one year (an expected decline of between 4 and 8 points in the Alzheimer's Disease Assessment Scale-Cognitive subscale) but also donepezil (about a 2 point decline in ADAS-Cog scores).
At high concentrations in early Alzheimer's disease and in those with a functioning sigma-1 receptor, Anavex 2-73 led to an average 2 point improvement in Mini-Mental Examination Score at 57 weeks (the rough equivalent of a 4.6 improvement in ADAS-Cog scores). Four out of six patients improved, one remained at baseline, and one declined in this cohort (57 weeks results). At 148 weeks, there was only about a one point mean decline in MMSE scores at high concentrations which would make Anavex 2-73 a disease modifying treatment for Alzheimer's disease (148 week results). The change in the Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) scores was not as dramatic at 57 weeks mostly because there is relatively little change in basic abilities during the early stages of the disease, but the gap grew much larger at 148 weeks.
The phase 2a trial was a very small trial. In the much larger phase 2b/3 trial the combined 30mg and 50mg met the cognitive endpoints as measured by ADAS-cog and CDR-SB (Clinical Dementia Rating-Sum of Boxes) scores (amended CTAD presentation). Moreover, Anavex Life Sciences has said that the findings in this trial were consistent with the phase 2b trial in which the medium concentration group performed no better than placebo but in which the high concentration group performed better than any previous drug or drug candidate for early Alzheimer's disease. In the phase2b/3 trial, those who improved at 48 weeks by more than -.5 ADAS-Cog scores did so by an average of approximately 4 points which is right in line with the high concentration group in the phase 2a study.
Anavex Life Sciences has not released (or perhaps still has not completed) its full data set which has left the company open to various broadsides. However, the only thing that matters is the actual data and how the FDA views it. The negotiations between the company and the FDA may well center around the question of whether there were enough participants in the high dose group to establish statistical significance despite having achieved clinical significance. If the FDA grants accelerated approval, then Anavex would be able to sell blarcamesine, while it undertakes trials in the U.S. with larger numbers of participants taking the high dose. If the FDA requires Anavex to undertake a larger trial before approval that will hurt the company's stock and deplete some of its reserves, although this may be slightly offset by potential approvals in Australia and Europe. In either case, a partnership is likely needed for commercialization of blarcamesine. For investors, it is a matter if it will take a little bit more patience or a lot more patience.
Blarcamesine appears to work as well as it does because it intervenes at a critical junction in the process that leads to the onset and early progression of Alzheimer's disease. By limiting the release of intracellular calcium, blarcamesine produces a myriad of benefits including the following: it maintains levels of neurotransmitters needed for the retrieval of short-term memory, sleep, mood, social recognition, and alertness, inhibits the breakdown of acetylcholine (which is needed for the retrieval of short-term memories), regularizes neurotransmissions, prevents mitochondrial dysfunction, lowers neuroinflammation, allows for the regeneration of neurons, synapses, and axons, and prevents the death of neurons. Perhaps most importantly, it limits oxidation and nitration which is why it ameliorates many of the problems listed above (study). Blarcamesine may also directly limit the influx of calcium further inhibiting oxidation and nitration, scavenge the oxidants hydrogen peroxide and peroxynitrite (ONOO-), and partially reverse oxidative and nitrosative damage, although studies in this regard are inconclusive. In any case, one of the best ways to greatly slow the progression of early Alzheimer's disease is with an effective sigma-1 receptor agonist such as blarcamesine (study).
Blarcamesine can produce dizziness and confusion at the highest dose which caused 17 dropouts and 24 down-titrations in Anavex's latest trial (although giving blarcamesine before bedtime may partially address at least the problem of dizziness), and it is considerably less effective in those with sigma-1 receptor variants. Two questions, then: what treatments might help these type of patients and what combination therapies might help others, especially ApoE4 carriers who progress more rapidly in early Alzheimer's disease?
You tube video:
Dr. Simon Stott fokuser primær på Parkinson, men nævner også Anavex og deres AD fase 2/3:
Fra 10:50 starter omtalen af 2-73.
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Anavex Link til Dr. Simon Stott og 2-73 i Parkinson.
Fra 10:50:
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.. Det er vel lidt af en no brainer ikke at give "accelerated approval", på et præperat som; Har ingen større bieffekt, i et tidlige stadie kan bremse AD. eller sågar forbedre tilstanden! Tiden er den vigtigste faktor her. Her er AI også en meget vigtig faktor, hvem respondere og hvem gør ikke?
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Anavex Fredag er option dag - relativ store spil omkring 10 $.
Relative store spil omkring 10 $ optioner og puts, så formår MM/udbyderne at manipulerer kursen til omkring de 10 $, så vil mange spil være værdiløse og spiludbyderne kan bare inkasserer betalingen for indsatsen!
Dette har vi set gang på gang, selvom det er ulovlig at manipulerer en aktie til fordel for dette højst mærkværdige og i min optik destruktive form for "spil", er dette en fast del aktiemarkedet, hvor de store spillere suger $ ud af de mindre aktører.
Svarer lidt til at Danske spil udbyder et spil på en fodboldkamp, men hvor de selv agerer dommer og kan påvirke udfaldet af kampen!
I håndbold kører der pt en større sag omkring matchfixing - i aktiemarkedet sker dette dog hver eneste dag i mange aktier uden konsekvenser og til langt større beløb! -
Anavex Ingen AA godkendelse til LLY og Donanemab!
Eli Lilly forsøgte at få en acceleret godkendelse på deres fedtfjernelsespræparat i fase 2 i Alzheimer - tilsvarende Biogens Lecanemab.
Dette er dog blevet afvist af FDA, så de må nu afvente deres fase 3 forsøg og køre den traditionelle vej.
Et spinkel håb for at FDA har lidt fornuft tilbage - eller måske har Biogens kritisable tætte forhold til FDA bare været bedre end Eli Lillys?
FDA krævede at min. 100 AD patienter var på aktiv stof for at opfylde kriteriet for størrelsen af patiengruppen - Anavex har til sammenligning 170 pts i både 30 og 50 mg - så selv med 80 % (WT genet) af 50 mg gruppen, havner antallet på ca. 136 pts på højste dosis 2-73, herfra fratrækkes dropouts - stadig tilstrækkelig til at opfylde denne del af en evt. AA ansøgning.
U.S. Food and Drug Administration Issues Complete Response Letter for Accelerated Approval of Donanemab
/PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced the U.S. Food and Drug Administration (FDA) has issued a complete response letter for the...
(www.prnewswire.com)
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