ANAVEX. NY TRÅD NY TRÅD over 100 % indrulning i Alzheimer!
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Anavex Flere forlader fdas advisory committe:
FDA AdCom roster shrinks as two quit over Aduhelm approval
(Ref: Washington Post, Business Insider, National Post)
June 9th, 2021
By: Anna Bratulic
Tags: Top Story Aduhelm Biogen Eisai FDA Dementia General Practice Internal Medicine Regulatory AffairsMayo Clinic neurologist David Knopman on Wednesday became the second member of the FDA's Peripheral and Central Nervous System Drugs Advisory Committee (AdCom) to resign in protest at the agency's decision earlier this week to approve B
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Skal love for at der er gang i andedammen efter den godkendelse, tror de fleste er dybt chokerede. Selvom de er desperate med at få en medicin på marked kan men jo ikke bare ændre reglerne i dette ene tilfælde og godkende aducanumab, der er helt forrykt.
Jeg vil godt vædde på at ham der Billy Dunn (FDA neuro chief) at han ikke er i FDA om 1-2 år.
Men okay han får nok tilbudt et fedt job hos Biogen med aktie optioner/pension/fri syge sikring til hele familien som tak for hjælpen.
Han var allerede i søgelyset sidste år med same medicin:
https://endpts.com/advocacy-group-accuses-fda-neuro-chief-billy-dunn-of-misconduct-in-controversial-biogen-review-demands-a-purge-and-federal-probe/Mon ikke Anavex kommer med nogle data næste uge? Jo senere vi kommer til enden at dette kvartal jo mere og mere sandsynligt er det, ha-ha.
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Tror desværre at EMA og de øvrige godkendelses agenturer/myndigheder ligesom FDA vil komme under et ret stort pres fra patientforeninger (læs fx. nedenstående fra Den Danske Alzheimerfirening). Også Aduhelm konkurrenter, der baserer deres behandling på beta amyloid tesen, fx. svenske Bioarctic, lyder meget optimistisk, lyt fx. til indslag i dag med deres CEO, https://www.youtube.com/watch?v=xFqk6_jY9As
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Man skal da vist huske at købe når stockpicker TDT123 strør om sig med guldkorn (-:
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Saa har det 3 medlem af FDA's ekspert rådgivnings panel sagt op over aducanumab's godkendelse og kalder det den værste godkendelse i nyere US historie.
Det kan man kalde "backfire" i stor stil.De skriver i artiklen at FDA ikke altid følger ekspert panelets anbefalinger i 1 tilfælde ud af 5 men kun når ekspert panelet er ikke så sikre. I aducanumab's tilfælde sagde 10 nej og en usikker! Ikke en sagde ja! Saa i dette tilfælde var ekspert panelet ikke i trivl om at det ikke boer godkendes men det valgte FDA at ignorere!
Third member of FDA expert committee resigns over controversial Alzheimer's therapy decision
Kesselheim wrote that the approval of Biogen’s Aduhelm “was probably the worst drug approval decision in recent U.S. history.”
STAT (www.statnews.com)
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Anavex Alzheimers is open for business!
Sørgeligt at det bare er penge der styrer det hele og ikke videnskaben - men dette kan som tidligere nævnt bane vejen for f.eks Anavex og andre innovative tilgange til behandling.
Alzheimer kan blive det nye hotte segment for investorer!
"I've had probably hundreds of discussions, of calls, from bankers, investors, collaborators, pharma, you name it," Tolar says. "Alzheimer's is open for business."
The signal sent by Monday's approval may be a pathway for future drugs, rather than an end itself. The data is imperfect, the costs high, and the controversy considerable, but the band-aid has been ripped off.
https://news.yahoo.com/alzheimers-open-business-controversial-fda-204457468.htmln
3 ud af 11 eksperter har sagt fra over for FDA - vi nærmer os de 40 %, som svare til det antal patienter, der får blødninger i hjernen af ADU - og som FDA åbenbart har det fint med - det er den største skandale for FDA hidtil!
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Anavex. Wall Street fester med Alzheimers selskaberne
Ignore Biogen: 3 Reasons These Stocks Will Be Better Alzheimer's Investments
When the Food and Drug Administration (FDA) approved Biogen's (NASDAQ: BIIB) aducanumab -- now marketed as Aduhelm -- for treating Alzheimer's Disease, it marked the end of a long drought. No matter how that turns out, the low bar for approval set by the FDA is likely to open the floodgates for Alzheimer's treatments. It has investors in Cassava Sciences (NASDAQ: SAVA) and Annovis Bio (NYSEMKT: ANVS) excited about their candidates, which are currently in clinical trials.
Yahoo Finance (finance.yahoo.com)
SAVA og ANVS promoveres selv om de er langt fra mål og meget længere end Anavex.
Ingen tvivl om, at der akumulleres aktier fra Anavex i stor stil af profferne. Mon ikke de så sælger lidt af konkurrenternes
Mon ikke dagen kan byde på et breakout over $16
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Anavex. Igen bliver Anavex overset.
De burde som minimum være blevet nævnt i Yahoo artiklen - hvis Anavex havde præsenteret Peer Reviews for PDD var de måske også dukket op på radaren, sammen med SAVA og ANVS - denne mulighed blev forpasset i denne omgang.
Men Anavexs tid skal nok komme - hvis resultaterne bliver som stillet i udsigt.
Vigtigst er dog, at markedet igen har fået øjnene op for segmentet! -
Ret interessant at investorerne - retail tror jeg - springer på de to aktier efter en ikke videnskablig artikel.
Der sker sikkert det modsatte af hvad jeg troede. Lemmingeeffekten gør at nogle springer fra ANXL og til de to omtalte konkurrenter (måske)
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Helt enig Tasso & Solsen.
Monthly fool nævner ikke os men de 2 andre og straks flyver de små investorer til og trykker på købs knappen.
"The Fool" er mere eller mindre i lommerne på WS.
Paa sigt er det bedre at sådan et enormt firma som Blackrock ejer over 5% af AVXL, de har skrappe analytikere der har forstand på tingene.
Vi må håbe at der kommer data næste uge så vi ved 100% hvor vi står, er skam stadig optimist.
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12 dage i streg med grønne lysestager, syntes faktisk bedre om disse mindre bevægelser, bevares! Selvfølgelig kun hvis de er grønne.
Tænker at 18 må være inde for rækkevidde, alene af den grund at market mener at chancen for nydhedsstrøm er utrolig tæt på, ingen vil misten muligheden for at være ude
hvis den rigtige PR dumper ind af brevsprækken.Det bliver ikke mere spændende, end det er nu ! !
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Interessant artikel i TIME:
https://time.com/6072980/alzheimers-drug-approval-controversy/
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Lidt fra National Institutes of Health om AD hvor AVXL er nævnt i et skriveri fra mit adopterede hjemland Thailand:
The emerging role of the sigma-1 receptor in autophagy: Hand-in-hand targets for the treatment of Alzheimer's
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Anavex. Hård kritik af Biogen og FDA på CNN!
En af de 3 fratrådte fra FDAs ekspertpanel giver her på CNN sin forklaring på, hvorfor han trak sig!
Ja - der er ekstrem meget fokus på Alzheimer området nu - se bare reaktionen på SAVA og ANVS efter en mindre artikel på Yahoo.
Anavex er nu en krudttønde, hvor overbevisende gode resultater ville kunne få det hele til at eksploderer.
Teknisk (TDT123) og dækningsmæssigt kunne en PR fra Anavex næste uge, ikke være mere perfekt!Anavexs Walter Kaufmann er jo også på den 18. juni med sidste nyt fra RETT - så mon ikke han har hele pakken fra Peer Review med her!
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Anavex. Indrulning i Alzheimer fase 2/3 forsøget - ikke afsluttet.
En detalje!
Iflg. indlæg på IHUB, har enkelte talt med IR hos Anavex, for at få bekræftet, at fase 2/3 forsøget er færdig indrullet.
I PR.en står der jo kun, at man nu har indrullet flere end de nødvendige 450 patienter og ikke at man har stoppet optagelsen af nye patienter.
IR har angivelig bekræftet, at indrulningen ikke er stoppet og at der forsat står patienter i kø for optagelse.
( Det jo en 14 dages testningsprocedure om man er egnet til forsøget, inden man evt. bliver indrullet )Dvs. at nedtællingsurret reelt endnu ikke er startet på de 48 uger!
For at sikre bedst mulig grundlag for et signifikant resultat, ville det være meget fornuftig, at polstre forsøget med flest mulige patienter - måske + 500-600 og samtidig få sikret et vist antal patienter på samtlige af de 52 aktive sites, så alle sites potentielt kan have nogle superresponder iblandt. ( Flere forsker/læger ville så med egne øjne kunne se effekten i deres patienter )
Anavex får aldrig bedre mulighed end nu til at få flest mulige patienter indrullet - senere kan Biogen effekten jo måske ødelægge optagelsen i nye forsøg generelt.Vi kan derfor nok forvente endnu en PR omkring afslutning af indrulningen og en reel start af nedtællingsuret.
Det vi nu har set fra Biogen og FDA, tydeliggøre nødvendigheden af den strategi Anavex har kørt, med forsøg kørt udenfor US og den grundige sikring af patenter og underbyggende forskning, således at man som et lille Biotek selskab har bare en lille chance i en biotekverden, hvor det meste i sidste ende bestemmes af penge og indflydelse!!!
Dette vi ser nu og den næste tid vil være et historisk vendepunkt i CNS forskningen - og vi stå midt i dette som investorer!
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Anavex. Videnskabelig underbygning MOA af både 2-73 og 3-71!
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Højde punkter (fra min e-mail inbox):
Scientific Paper Highlights:
• Sigma-1 receptor (SIGMAR1)'s expression increases with age, however in Alzheimer's disease (AD) it decreases
• The decrease in SIGMAR1 expression during AD coincides with an age-related decrease in autophagy
• The SIGMAR1 may compensate for loss of receptors and autophagic machinery during healthy aging
• SIGMAR1 is activated by ANAVEX-compounds
• ANAVEX
2-73 has been shown to induce autophagy
• Activation of the SIGMAR1 can induce cytoprotective autophagic pathways -
NEW YORK - June 14, 2021 - Anavex Life Sciences Corp. ("Anavex" or the "Company") (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer's disease, Parkinson's disease, Rett syndrome and other central nervous system (CNS) diseases, today reported that ANAVEX
2-73 (blarcamesine) and ANAVEX3-71 (AF710B) are featured in a new peer-reviewed publication in the journal of Expert Opinion on Therapeutic Targets, titled "The emerging role of the sigma-1 receptor in autophagy: Hand-in-hand targets for the treatment of Alzheimer's". [1]Scientific Paper Highlights:
• Sigma-1 receptor (SIGMAR1)'s expression increases with age, however in Alzheimer's disease (AD) it decreases
• The decrease in SIGMAR1 expression during AD coincides with an age-related decrease in autophagy
• The SIGMAR1 may compensate for loss of receptors and autophagic machinery during healthy aging
• SIGMAR1 is activated by ANAVEX-compounds
• ANAVEX2-73 has been shown to induce autophagy
• Activation of the SIGMAR1 can induce cytoprotective autophagic pathwaysThe authors of the paper point out that studies using positron emission tomography (PET) have shown that in healthy aging, there is no loss of the SIGMAR1; in fact, there is a possible increase in SIGMAR1 expression [2] that coincides with the age-related loss of the M1/M4 muscarinic receptors [3], D1/D2 dopamine receptors [4], and serotonin (5HT2A) receptors [5]. The increase in SIGMAR1 expression may be a compensatory mechanism for the loss of the other receptors [6].
However, PET scans of patients with a recent AD diagnosis show a reduction of SIGMAR1 expression [7]. SIGMAR1 also promotes autophagy and results in the degradation of amyloid-beta precursor protein (APP) thereby inhibiting Aβ production [8].
The publication explains that AD is a multifactorial disease, where several pathways interlink with each other and cause cognitive impairments. The available drugs only tend to target a single pathway and mitigate the symptoms of AD without slowing the disease progression. Combinatorial therapy has been suggested as a treatment strategy; however, the existence of drug-drug interaction is a concern. Hence, there is a need for the development of drug molecules that can target multiple pathways to halt disease progression and improve the memory function.
SIGMAR1 has emerged as one of the prominent targets in treating neurodegeneration. It is involved in the modulation of glutamate levels, maintaining endoplasmic reticulum (ER) function, and calcium regulation, promoting neurogenesis, reducing reactive oxygen species (ROS) formation, suppressing neuroinflammation and ameliorating Aβ toxicity [9] . Recent studies with ANAVEX
2-73 show that SIGMAR1 activation is also involved in autophagy, an intricate phenomenon that clears damaged cellular organelles and misfolded proteins [10]. SIGMAR1 agonists, including ANAVEX2-73 and ANAVEX3-71 have been reported to block toxic Aβ, tau and neuroinflammation [11].Autophagy and the cellular machinery involved are essential to homeostasis and cell survival. Autophagy has been shown to be important for axonal health and homeostasis as autophagy inhibition leads to axonal wasting [12].
During the early stages of AD, it has been noted that there is an accumulation of Aβ and tau protein in the dystrophic or swollen neurites of AD patients' brains. Furthermore, it is well known that autophagy plays a key role in the management of Aβ and tau protein levels, and that some of the key proteins involved in the autophagy mechanism disappear with age, resulting in decreased autophagy in older brains [13]. At the same time the SIGMAR1 is upregulated, possibly compensating for the reduction in autophagy, and reduction in other receptors, such as muscarinic receptors [14], dopamine receptors [15], and serotonin receptors[16], in an attempt to protect the neuron cells.
Since it has been observed that a number of SIGMAR1 agonists, including ANAVEX
2-73, is able to upregulate SIGMAR1 expression in the brain, it is possible that these drugs could help the cells to compensate for the loss of other receptors and autophagy machinery.The authors conclude, that in the future it may be the case that SIGMAR1 ligands (or drug combinations) targeting the activation of autophagy, and other SIGMAR1 related neuroprotective pathways, are prescribed prophylactically, in much the same way as with statins for the prevention of heart disease today in an effort to prevent the loss of the SIGMAR1 receptor seen during AD.
"This independent paper highlights the understanding of the relevance of utilizing sigma-1 receptor activation as compensatory mechanism to chronic CNS diseases, currently tested in late-stage placebo-controlled ANAVEX
2-73 Phase 2b/3 clinical Alzheimer's disease study, which recently completed enrollment, as well as in Parkinson's disease dementia (ANAVEX2-73-PDD-001) and ongoing Rett syndrome program (ANAVEX2-73-RS-001/002/003)", said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex.ANAVEX
2-73 activates the sigma-1 receptor (SIGMAR1). Data suggests that activation of SIGMAR1 results in the restoration of complete housekeeping function within the body and is pivotal to restoring neural cell homeostasis and promoting neuroplasticity. [17]Anavex Life Sciences' product portfolio platform includes small molecule drug lead candidate ANAVEX
2-73 for the treatment of Alzheimer's disease, Parkinson's disease and Rett syndrome and ANAVEX3-71 for frontotemporal dementia. -
Jonestrading AVXL nyt pris mål: 35$
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