Anavex. Ny tråd - marts 2024.
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Tror alle er klar over at FDA foretrækker de store tunge bio selskaber og "hjælper" dem med godkendelser. FDA ansatte går ofte over til en af disse selskaber efter +25 års tro tjeneste (livs pensions)i FDA.
Nok ikke tilfældigt at Anavex søger i EU først, en godkendelse der vil nok tvinge FDA at følge trop men det forsinker det hele med et år eller 2.
En partner som før nævnt kan ændre det hele for Anavex og jeg håber at de har noget kørende?Vores kurs under 4$ er ikke noget at råbe hurra for for at sige det mildt, institutionerne køber op hvilket jo er mere positivt end negativt men de låner jo gerne deres aktier ud så de kan shortes. Saa tjener de penge mens de tålmodigt venter.
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With fresh $100M, Alzheon lays out strategy for Alzheimer's approval next year https://firstwordpharma.com/story/5866062
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Det er jo ikke FDA, der har anbefalet at Donanemab godkendes, men iflg, Nature, der absolut er en ret seriøs videnskabelig journal, eT panel bestående af 11 (formodede!) uafhængige eksperter, se
https://www.nature.com/articles/d41586-024-01726-w
Disclaimer: Har p.t. selv 5000 stk. AVXL og 100 stk. LLY
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Anavex. Oversigt andel større investorer.
Alt andet lige burde det være et positiv signal, trods en del aktier sikkert går til udlåning til shorts.
Tankevækkende, at patienter ved behandling af Donanemab efter 18 mdr. mister 1,4 teskefulde hjernemasse mere end placebogruppen, der jo mister hjernemasse i forvejen i den naturlige ældningsproces.
Den tabte hjernemasse svarer iflg. ovenstående artikel til massen af neuroner, der går tabt!
Iflg. Missling har man i AD fase 2/3 forsøget med Blarcamesine set ikke bare en opbremsning af dette tab af hjernevæv, men endda en reversering!
Dette alene burde gøre, at Blarcamesine burde være tilgængelig for alle der måtte ønske at forebygge denne åbenbare negative indvirkning et tab af neuroner vil have på det generelle helbred - især hvis behandlingen med Blarcamesine ikke indebærer nogen bivirkninger! -
Det er korrekt Thorkild. Det er eksterne eksperter der giver deres vurdering.
FDA er så ikke forpligtet til at agere som eksperterne anbefaler. Men det gør de i overvejende grad.
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HA-ha Fandel, det er en meget simpel konklusion.
De er vel som mange offentlige institutioner, tunge at danse med, sikkert underbemandet, ændringer tager meget lang tid og det samme med ansøgninger. Vi boer huske at de er ved at ændre AD ansøgnings kravene som helt sikkert er til Anavex's fordel (se anden vedhæftning) så noget sker der.
Som du kan se har de mange jern i ilden og omkring 16.000 ansatte, her er lidt at tygge på:
FDA
Government AdministrationMaryland, United States10001+ Employees
The Food and Drug Administration is an agency within the Department of Health and Human Services.
The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.
FDA also has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors.
FDA is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health.
FDA also plays a significant role in the Nation's counterterrorism capability. FDA fulfills this responsibility by ensuring the security of the food supply and by fostering development of medical products to respond to deliberate and naturally emerging public health threats.
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Anavex Generalforsamling den 18. juni 2024.
Inderholder bl.a. et punkt 4, hvor en aktionær indstiller, at aktionærerne skal spørges ved ekstraordinær høj fratrædelsesgodtgørelse til en CEO (Missling pt.)
Som forventet anbefaler bestyrelsen, at stemme imod dette forslag, bl.a. med en begrundelse af, at man vil få svært ved at tiltrække og fastholde en kvalificeret ledelse.
Bestyrelsen henviser til, at de følger den alm, praksis på området.Tror ikke forslaget bliver vedtaget, da de større investorer som regel følger ledelsens indstilling, men dette er dog en vink med en vognstang til ledelsen og CEOen, at der hos flere aktionærer er utilfredshed med belønning af især CEOen ikke står mål med en positiv udvikling af aktiekursen! - at casen faktisk er meget positiv med en forventet ansøgning til EMA indenfor de næste par mdr., ændre ikke på, at håndteringen af CEOen og ledelsen har været kritisabel og mangelfuld især vedr. kommunikationen til markedet og aktionærerne.
Positivt også, at et sådan forslag finder vej til en generalforsamling, selvom ledelsen ikke understøtter det.
Man kan håbe på, at de fremadrettet vil kommunikerer mere og tydligere overfor især aktionærerne, vel vidende at der et tydeligt krav fra aktionærerne, at der skal leveres, hvis der skal være en sammenhæng med belønninger.På vedhæftede link fremgår også Misslings optionsplan (retten til at købe aktier på bestemte tidspunkter).
På nær de 500.000 optioner til kurs 0,92 $ april 2025, så er der ikke den store bonus i sigte, hvis kursen på Anavex skulle forblive i nuværende niveau eller lavere.
Ud fra det har jeg det ok med, at Anavex og Missling skal skabe en positiv udvikling herfra, hvis bonusserne skal blive betydelige.
Optionsplaner som denne er normal praksis og understøtter dermed også ledelsens påstand om, at disse er nødvendige for at tiltrække og fastholde dygtige medarbejder.Vi gå snart ind i 8. Mdr. for ansøgningsprocessen!
Fra en udtalelse af Missling i starten af året, ved vi dog, at Anavex stadig manglede at få tildelt rapportører fra CHMP, som skal følge/sparre med Anavex i ansøgningsprocessen. Om dette evt. har forlænget forløbet udover de normale 6-7 mdr. ved vi ikke.
Tilbage står dog, at Missling ved sidste CC bekræftede at processen var helt på sporet og i positiv dialog med EMA.Rapportører - som tidligere beskrevet skal der tildeles 2 rapportører, fra 2 af de 27 medlemslande, der sidder repræsenteret i CHMP. Disse skal så uafhængig af hinanden med hjælp fra deres faglige bagland/netværk følge og være i løbende dialog med Anavex, for kontinuerligt at tilpasse ansøgningen efter den udformning EMA/CHMP ønsker.
Denne proces gør så også, at indsendes en endelig ansøgning til EMA, at minimum 2 repræsentanter højst sandsynlig har sagt god for udformningen og indholdet af ansøgningen.
Derfor er bare den milepæl, at få indsendt en endelig ansøgning et kæmpe skridt mod en endelig markedsgodkendelse, hvilket også fremgår af statistikken siden 2016, at 87 % at accepterede ansøgninger til EMA også fik en markedsgodkendelse i sidste ende.Der kommer nyt, når tingene er klar - men havde dog forventet, at ledelsen havde lidt positive nyheder op til GF på tirsdag.
Så vil holde ekstra øje med evt. nyheder de næste 2 dage. -
Anavex har ansat yderligere et par statistikfolk de seneste måneder:
https://www.linkedin.com/in/yunfan-li-23a14a1a/
https://www.linkedin.com/in/flosy0501/De kommer fra hhv Karuna og Eisai - begge selskaber tæt på det Anavex arbejder med.
Anavex har ikke opgivet
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Anavex har kommenteret på ny FDA AD Guideline!!!
Kort og godt giver det indtryk af, at Anavex har data fra deres AD forsøg, som modsvarer de forbedrede tiltag/tilføjelser man foreslår til de fremtidige retningslinjer FDA mener skal være gældende fremadrettet.
Underbygger også, at Anavex som annonceret vil forsætte en ansøgningsproces med FDA efter EMA.
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Anavex Positiv Seeking Alpha artikel.
Svar fra Lane Simonian - han fik bl.a. ikke nævnt Blarcamesines evne til at bremse tabet af hjernevæv.
"I agree with Irwin's analysis. Blarcamesine works upstream of amyloid plaques, and may also increase their removal. More importantly it inhibits oxidative stress early in Alzheimer's disesae.
Inhibiting brain shrinkage may be an important measure of blarcamesine's effectiveness.
Meauresements of changes in activities of daily living may be difficult to assesss during mild cognitive impairment. It is encouraging that in the earlier 148 week trial, both cognition and activities of daily living stayed near baseline in most of those with the highest concentrations of blarcamesine. In any case, the FDA's apparent acceptance of just the ADAS-Cog measure should work in Anavex's favor.
If larger numbers of patients on the highest dose of blarcamesine peform similar to those at the highest concentrations of blarcamesine (both at about three years), then Anavex is a good shape." -
Indsidder køb i småtings afdelingen https://archive.fast-edgar.com/20240617/AN2ZVQ2CX222UZR222232ZE26DA6Z2229862/
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Kopieret fra en messenger gruppe.
En gut ved navn Jerry, som har været til GF i dag.Ok, just off the train and will try to summerize highlights as best as possible...EMA...manufacuring of 2-73 has been solidified with a leading contractor that meets MMA stanardards. This is a key component of filing. All t's being crossed and i's dotted. Very volumous and needs to be submitted all at once, most likely early Dec was my take. Left the door open of how best to distribute, most likely some sort of partnership but wants it to be most benefit $$ for shareholders. Miss reiterated that EMA urged AVXL to file and final approval could take 6-9 months. FDA..AVXL is waiting for final endpoint guidance determination before meeting with them. He insinuated that he was confident with current data available along with ongoing OLE.He didn't know how long this would take but hopeful before EOY. Retts..another larger trial of 12 weeks is required but they learned a lot from 1st opps. He seemed confident they would get it over the goal line early next yr and specifically mentioned that people don't like only thing currently available Name of drug escapes me. 3-71 Miss was extrmely upbeat about schizo trial. He specifically mentioned that he felt it has better efficacy than 'Karuna"? which BMY recently purchased for $14b...Miss was emphatic about 2-73's autophagy stimulation. Went on to say nothing else out there promotes this....Yes, the languishing SP did come up and one investor asked what could be done to enhance potential new investor enthusiasm. Miss frankly stated they have to execute and deliver. He acknowlded prior communication deficencies and said they would be more timely with PR updates on trial progression. In a sidebar conversation after the meeting Miss told a few of us that AVXL has recently initiated a riqourous Educational Webinar program targeting numerous Neuro groups, admitting that no one knows about us Feel free to ask me anything and I'll do my best to rack my brain to recall...A fair amount to digest in a little over an hour
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Anavex Fra en anden deltager på GF den 18. Juni 2024.
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As to the peer reviewed paper, he did say it would very likely be published before the MAA is submitted (although he did take care to say that they were completely independent events.)
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My understanding of what he said (and it was slipped in quickly) was that the MAA wouldn't be submitted before September. This is no surprise given what I have been saying about the submission request for rapporteur assignment. It was apparently made before the February 7th submission deadline, and at that point the EMA was therefore being told that it was projected to be filed between late August and early September. They have had the opportunity to amend the filing date since then. What he did specifically say in the presentation is what he has said publicly before, "It will definitely be filed this year."
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As to Schizophrenia, yes, he did say they were beyond the first cohort and I also understood that the second cohort was being dosed now. That does mean that Part B should be coming up fairly soon after that data is analyzed. In answer to my question Missling said that it was quite possible that the study could be finished before the end of the year.
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In answer to another trial question he did reiterate what he said on the last call - i.e., that the PD trial would start this year. As to Rett, he suggested that we would hear more about their plans at the Rett conference where they are presenting (this week?).
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He did make some more remarks on autophagy as a key component of the MOA. (Personally, I believe as the story of our drug comes out, this autophagy angle will provide a good bit of extra sizzle.)
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Yes, he did say that they have had no formal meetings with the FDA since the end of the AD trial (although it wouldn't surprise me if there had been some back channel communications). As he has said before, he plans to go to them when he has the OLE data/analysis and after he has filed the MAA. He did also say that the doesn't believe there is a need to wait on filing before the new FDA guidance on AD is fully approved and in the Federal Register. He showed a fair bit of confidence by saying that under the new guidance "the study should be fully approvable."
BTW, in regard to the full data set (in the peer reviewed paper, I presume), Missling said that we would be pleased to see the data "broken out by every arm of the study...all measures." He also threw out - in an apparent jab at Annovis (and others) - that the study participants were "all confirmed Alzheimer's patients."
Konklusion fra GF den 18. Juni 2024.
Med input fra andre kilder, med de forbehold man skal have:
Andre er meget velkommen til at supplerer!Indsendelse af ansøgning til EMA omkring september i år.
Peer Review/afhandling offentliggøres før - Missling nævnte, at vi bliver tilfredse med data udspecificeret på de forskellige arme i forsøget. ( placebo, 30 og 50 mg?)
Vigtig aftale med godkendt større producent af 2-73 på plads - er en afgørende del af ansøgningsgrundlaget.
Autophagy stimuleringen af 2-73 er afgørende og en unik egenskab, som intet andet medicin evner.
(Autophagy - stimulering af udrensningen af defekte celler, der ellers ville svække en sund proces - reelt en antiældningsmekanisme - lyder til at EMA har fanget det)Unik evne til at bremse tabet af hjernevæv.
AD OLE forsøget (afsluttes juli 2024) inddrages til ansøgningen hos FDA - ikke nødvendig for EMA ansøgningen - materiale fra EMA kan anvendes til FDA.
Forventet tid før EMA godkendelse 6-9 mdr. efter indsendt ansøgning. (sandsynligvis afhængig af om der tildeles acc. eller standard procedure)Juli 2024 ville Anavex også deltage på en konference vedr. nye RNA data fra AD forsøgene.
3-71 fase 2 i skizofreni er langt forud tidsplan, og ventes måske allerede afsluttet slut 2024.
Missling mener, at effekten af 3-71 er bedre end fra netop opkøbte Karuna - opkøbt for 14 milliarder $!Parkinson fase 3 opstartes i år.
RETT opstarter nyt fase 3 i år og Missling udtalte, at der ikke er udbredt tilfredshed med allerede godkendte Dayblue fra ACAD.
Der skulle komme nye data og planer frem omkring RETT på en konference, der har sidste dag i morgen den 19. Juni.Adspurgt om hvad Anavex og Missling havde tænkt sig at gøre for at imødekomme den lave aktiekurs, var svaret, at Anavex bare skal leverer varen nu - samtidig vil de oprette nogle webinarer og læringsvideoer mm. for at udbrede kendskabet til Anavex og deres videnskab - for Missling mente, at Anavex stadig er fuldstændig ukendt for mange.
Missling fremstod meget selvsikker og tilsyndeladende mere sikker på tidshorisonterne - september er lige om lidt og Peer Review/afhandlig for AD fase 2/3 skulle udkomme før.
Det med tidshorisonterne må stå sin prøve - igen, men processen med EMA er trods det i mere faste rammer, så hvis det er korrekt, at Anavex først fik tildelt de før omtalte CHMP rapportører omkring den 7. Februar i år, og man tillægger den normale EMA proces på 6-7 mdr, så passer september 2024 nok meget fint!Ubegribeligt - at markedsværdien med den fremskredende og omfattende pipeline, fratrukket kontantbeholdningen er vurderet til sølle 200 mill. $!!!
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Lige lidt som er hapset fra en Anavex gruppe på Messenger =
Hi, I got permission from a friends take to release his notes. Cheers.
They are calling themselves a regulatory stage CNS company.
Patients are peeling off of Trofinetide, and patients on Blarcamesine, through compassionate care schemes, are continuing on the drug. FDA gave them feedback on RETT to run another phase 3 trial because it would be unfair to Acadia (Trofinetide) who had a drug approved on a successful phase 3 trial if drug was approved despite missing statistical significance on endpoints. They are at a RETT conference concurrent with the ASM, to present a new trial (12 week), in which they will enroll 2x patients (~150) on a 1:1 ratio.
Saw a picture of the pill. It's a clear capsule with branding on the coating.
They have not met with fda on Alzheimer's because of the missed ADL, but now with the new draft guidance and bio-markers, and black box warning and failure of MAB uptake, feel much more confident to talk with them. When asked if European approval would be first and FDA second, he answered not necessarily because though they started with EMA, FDA is much quicker.
When asked about long-term efficacy, he said they have good data and RWE of AD patients on drug for 146 weeks. They have not seen any of the ATTENTION data on the OLE. When asked if FDA will accept aBeta as a biomarker using blood plasma, he said many companies have now adopted this method. On brain atrophy data, he used the following language (attenuated, stopped, delayed). He did not give any ground on timeline for EMA submission or peer review, but held to by 'end of year' though he conceded this was playing it safe, which I interpret as meaning it may happen earlier. We saw some new slides, one in which they do a much better job illustrating their drug vs the MAB's, comparing their downstream approach to the upstream approach of activating the sigma-1 receptor, emphasizing Autophagy. In my opinion, focusing on Autophagy, is smart because it gets lots of headlines in health news as it relates to intermittent fasting and other trending health fads regarding cell health.
They have completed part A of Schizophrenia trial which was a dosing study and have now started part B. When asked about delays with PD/PDD, he answered strongly that major advances were being made in PD biomarkers, and testing doesn't just come off the shelf at 'Amazon' as he put it, they are being developed, and thus they are waiting because they feel they can run a more effective trial with them. He used the 2b/3 AD trial as an example, suggesting at the time they initiated that trial, the biomarkers they were testing for were not at all common then, but are now common in most AD trials. His comments seem to be pointing toward the new alpha-synuclein biomarker discovered by the Michael J Fox foundation last year.
In a question asked about partnering versus buyout, he first responded by saying that a buyout is an extreme form of partnership and at the other end of the spectrum was doing everything themselves. He indicated he was open to all options, with the criteria that it would be whatever was in the best long term interest of shareholders.
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Og lidt mere =
As I suspected, the PD trial has been delayed for very good reasons and has increased in size and scope. I'm also glad all my donations to MJFF over the decade have been fruitful.
"When asked about delays with PD/PDD, he answered strongly that major advances were being made in PD biomarkers, and testing doesn't just come off the shelf at 'Amazon' as he put it, they are being developed, and thus they are waiting because they feel they can run a more effective trial with them. He used the 2b/3 AD trial as an example, suggesting at the time they initiated that trial, the biomarkers they were testing for were not at all common then, but are now common in most AD trials. His comments seem to be pointing toward the new alpha-synuclein biomarker discovered by the Michael J Fox foundation last year. "
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Marwan præsenterer på AAIC 2024.
https://alz.confex.com/alz/2024/meetingapp.cgi/Paper/90729?fbclid=IwZXh0bgNhZW0CMTEAAR1MP0o5N3dR9BAZbGnZYacHDrM7bf6srP5jc70-_QSAf3nhOyioZR5UVPo_aem_S_woPgqgHxzSYD7Cfiyq-QDet bliver interessant.
Han kan måske slippe katten ud af sækken
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1,5 times præsentation af dr. Marwan Sabbagh, Fmd for scientific board.
Bedre kan vi ikke ønske. Husk at han sagde, at der vil komme overraskelser i år (video lagt op tidligere i denne tråd)
Det kan være det event som Missling omtalte, hvor AD-data eller dele blev offentliggjort, hvis ikke peer review kom før.
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Anavex Det er det helt rigtig sted og præsenteret af den absolutte helt rigtige mand!
Tror dog ikke at han har mere end 15 min. - Anavex er en blandt flere, der skal præsenterer indenfor den 1 1/2 time.Marwan Sabbagh er en af de største og mest anerkendte kapaciteter inden for Alzheimer!
Har lyttet til flere videoer med ham, og det er tydligt, at han med hans enorme viden brænder for området og især med patienterne i fokus.
Det er også vigtigt, at han er uafhængig og han først blev tilknyttet Anavex efter AD fase 2/3 TLD december 2022, som formand for den eksterne ekspertgruppe.
Tror folk vil lytte meget mere til Marwan Sabbagh end Missling.
Marwan Sabbagh, MD, FAAN
Marwan Sabbagh, MD, is a behavioral neurologist and the Moreno Family Chair for Alzheimer's Research in the Alzheimer’s and Memory Disorders Program at
Barrow Neurological Institute (www.barrowneuro.org)
Om Peer Review udkommer før eller efter, så må indholdet af præsentationen på AAIC omfatte de væsentligste resultater fra AD forsøget inklusiv også Blarcamesines evne til at bremse tabet af hjernevæv mm.
Dette må absolut rykke ved kendskabet til Anavex og deres videnskab.
Det store spørgsmål er, hvem vil sælge 22 mill. aktier til shorterne inden den 28. juli - de får ikke mine!
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