Anavex Dialog med EMA om godkendelse af 2-73 i Alzheimer!!!
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Anavex Fik nu mulighed for at høre webcastet.
Er helt på linje med Solsen, at processen med EMA er meget positiv og giver stor optimisme omkring en markedsgodkendelse i EU.
EMA har set hele den datapakke fra AD fase 2/3 forsøget, som igen bekræftes udgivet som en Peer Review i en nær fremtid - ingen angivelse, hvornår vi får denne - men det må være meget snart, når datapakken var så udspecificeret og komplet, at de var gode nok til en præsentation for EMA.
EMA synes dog modsat FDA, at være tilfredse med data fra selve fase 2/3 forsøget og behøver ikke at afvente data fra OLE forsøget, der efter 96 uger afsluttes juni 2024 - dette studie er iøvrigt blevet forlænget til 144 uger, hvor patienter der også nu har afslutte dette er overgået til compassion use.
Hele 90 % forsatte i OLE forsøget - og der var iflg. Missling forsat stor efterspørgelse af 2-73.
Lyder som om, at Anavex med aftalen med Partex, måske tænker at gå egne og nye innovative veje til en markedsføring i EU?
FDA ser ud til at vil se OLE data integreret i en evt. ansøgning i US, hvilket godt kan begrundes - men både ren etiske (pga. de mange sites i EU) og tilfredsheden med AD fase 2/3 data alene, kan denne vej med EMA være mere rigtig og hurtigere.
Missling understregede, at man sideløbende køre processen med både FDA og AUS.RETT Excellence er åbenbart lidt forsinket pga. en efterfølgende analyse af bivirkningsprofilen, hvilket nok også lyder plausibel, når man har med sårbare børn at gøre og hvis de samlede data i hele RETT programmet skal danne endelig grundlag for en ansøgning om markedsgodkendelse.
Ellers kan vi forvente flere separate udgivelser fra programmet og opstart af bl.a. et 6 mdr. langt Parkinson forsøg og opstart af andre forsøg fra pipelinen.
Anavex har åbentbart lagt sig fast på, at der hele tiden skal stå ca. 150 mill. $ på bogen, uanset hvilken kurs man løbende kan sælge aktier til.
Dette gør dem meget mindre sårbar og herre i eget hus.
At der nu er ca. 82 mill. udestående aktier er en lille pris at betale i min optik.Alt i alt ikke den bedste CC, da man igen ikke fik nogle tidspunkter sat på de kommende vigtige milepæle, hvilket derfor nok var årsagen til, at markedet straffede på aktiekursen.
Tror dog ikke Anavex selv kun er skyld i dette, da flere eksterne parter er involveret i de forskellige processer.
Alt tyder dog på, at videnskaben og resultaterne er valide, men at det hele bare tager noget længere end de fleste havde forventet. -
Endnu en fejler i Alzheimers
BioVie Inc. (BIVI) Stock Price, News, Quote & History - Yahoo Finance
Find the latest BioVie Inc. (BIVI) stock quote, history, news and other vital information to help you with your stock trading and investing.
Yahoo Finance (finance.yahoo.com)
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En god artikel, hvis I laver en gratis konto
Forfatteren omtaler potentiel godkendelse i foråret 2024. Det håber jeg er rigtigt, men det tror jeg ikke selv på
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Anavex Positiv og omfattende artikel, men godkendelse sidst i 2024 er nok mere realistisk - ting tager tid.
How Soon Might Anavex's Alzheimer's Drug Be Approved? The Good/Bad News
Nov. 29, 2023 7:21 AM ET
Anavex Life Sciences Corp. (AVXL)The Political Economist
Summary
The EU recommends Anavex proceed with a full approval application for Alzheimer's drug Blarcamesine based on full Phase 2b/3 trial data.
The U.S. FDA may grant accelerated approval to Anavex's Blarcamesine based on biomarker data alone. Blarcamesine is far safer than Biogen's Leqembi, which was granted accelerated approval in three months.The FDA may accept Anavex's ongoing ATTENTION-AD study as a supplement to the Phase 2b/3 trial, potentially shortening the full and regular approval timeline. That data comes out in 2023.
human brain
nopparitHere's the bad news. And the good news. From today's Anavex Life Sciences (NASDAQ:AVXL) conference call:
We have met the European Agency several times in meetings and we have shared the data which is not yet published, which is the published date of -- the planned published communication of the full data of the Alzheimer Phase 2b/3 study. And we were from this meeting recommended to proceed with this application, full approval application. And that's what we proceeded with last week accordingly.
The good news is, after showing the EU drug bureaucracy the Phase 2b/3 full data set, the EU recommended that Anavex "proceed with" a "full approval application." This implies that the EU sees the Phase 2b/3 drug trial results as sufficient at least to make a decision on approving (or not approving) Blarcamesine.
And Anavex has already applied to the EU for approval.
As discussed in previous articles, the drug looks both highly effective and safe. One of the remaining questions was whether regulatory agencies worldwide would require Anavex to do any further drug trials. The EU apparently does not see this need. That's good news.
The bad news. The EU is typically a good deal slower than the U.S. FDA in its drug evaluation and approval process. It could take over a year.
On the other hand, these regulatory agencies do not work in a vacuum. They understand the urgent need for a safe, effective, affordable Alzheimer's drug, and that patients "need it yesterday," so to speak. Might the EU fast-track the only effective Alzheimer's pharmaceutical that does not cause brain bleeding (like Biogen's Leqembi does)?
I think so.
The U.S. FDA Accelerated Approval Process
And what about the U.S. FDA?Anavex had been preparing to apply for Accelerated Approval by the FDA. This, from a previous (May 2023) quarterly conference call:
With newly available preliminary efficacy results of surrogate biomarkers, we consider initiating discussions with regulatory agencies for Accelerated Approval Pathway for ANAVEX2-73. In parallel, we plan to proceed with the initiation of our confirmatory Alzheimer's disease study.
Accelerated approval at the U.S. FDA requires that a drug demonstrate an effect on at least one related biomarker. Biogen's Alzheimer's drug, Leqembi, for instance, demonstrated an effect on amyloid plaques in the brain.
In a September press release, Anavex stated that Blarcamesine lowered the levels of amyloid plaques in the brain. Furthermore, Blarcamesine affected the ultimate Alzheimer's biomarker: brain volume. The drug slows the loss of brain volume. Both findings were statistically significant, with preventing brain loss being a result at an extremely high level of statistical significance.
So, that seems to check the biomarker box; all seems prepared for accelerated approval, right? Can they get accelerated approval with the biomarker data? How picky is the FDA regarding accelerated approval for Alzheimer's drugs? From the May conference call:
The next question is, will the AD NDA be submitted before the confirmatory trial is completed?
The answer is after discussion with the agency for Accelerated Approval Pathway, this would be the path which was also given to the other accelerated approval company approvals. So this could be the case as well. Otherwise, it would be not accelerated approval if you need a study to begin with. So that is the goal of getting the drug approved before completing a confirmatory second trial.
Here, CEO Missling repeats the goal of winning accelerated approval WITHOUT having to do a "confirmatory second trial" which might take another year. Indeed, from what the public has seen of their Phase 2b/3 trials, the drug is more effective than Leqembi in slowing cognitive decline as measured by the ADAS-Cog13 and the CDR-SB. And Leqembi was granted accelerated approval, as Missling states in the above excerpt, so Blarcamesine should be granted the same.
All is set, right? The biomarker data looks great. Leqembi won accelerated approval with biomarker data alone. Get the application into the FDA!
The U.S. FDA Regular Approval Process
The twist. During the August conference call, CEO Missling dropped this bomb on us:We have been heard from KOLs [Key Opinion Leaders] that actually this extension study [ATTENTION-AD] could be the confirmatory study of the ANAVEX2-73 Phase 2/3 study itself. So we want to basically put this in context and see how this will progress. Accordingly, so we might already have started this confirmatory study with that open-label study, but it will be determined in discussion with regulatory agencies. But we would, of course, be able to, without a problem, initiate a study, if so required, at any time.
Here, CEO Missling says that Anavex could apply for the regular approval process using the ATTENTION-AD OLE as the confirmatory study. The accelerated approval does not require a confirmatory study.
This week's quarterly conference call confirmed that Anavex would apply for FDA approval using ATTENTION-AD as part of the application package:
We have the ongoing ATTENTION-AD study ongoing and that's part of the package of the application with the Phase 2b/3 study.
Here, Missling does not specify whether he is talking about applying for regular approval or accelerated approval. Taking into account the declarations of the past three conference calls, Anavex appears to be applying for BOTH accelerated approval AND regular approval to market Blarcamesine for Alzheimer's Disease in the USA.
No matter which path they take, the timeline for approval may be about the same.
Here is the follow-up question to the August conference call excerpt from above:
Soumit Roy
I see. Do you have any date in mind when the FDA conversation could happen if this study can translate into a confirmation study?
Christopher Missling
Yes. We are planning to do this once the data is available, which is expected this year. And thereafter, agency is able to address things with data as well. And that's what will happen with data, in presence of data.
Here, the analyst Soumit Roy asks Missling when he will find out if the ATTENTION-AD study can count as a confirmatory study for the regular approval application. Missling says that the "data" will be available in 2023. I assume this means that ATTENTION-AD will be completed in 2023, which seems too early to me, considering the Phase 2b/3 study was apparently "completed" in "mid-2022" according to a 10-Q filing.
Whatever the case, it is on record that the CEO stated that the "data" will be "available" in 2023, and that data, along with the application to the U.S. FDA will move the stock value.
Stock Value and Timeline
Immediately after this week's conference call, AVXL stock tanked by about 10%. I am not sure what sellers were responding to, or if shorts brought the stock down.Recent events, press releases, and declarations by the company indicate that approval for a drug that can bring in tens of billions of dollars a year could come as early as spring 2024. AVXL has a market cap of about 500 million dollars.
It took only about three months for the FDA to grant accelerated approval to Leqembi after it reported Phase 3 results.
This is what I imagine Anavex will do: The company will put together the complete Phase 2b/3 clinical data along with Phase 2b/3 biomarker data (which just came out two months ago) along with ATTENTION-AD OLE data and hand it over to the FDA. This will represent 144 weeks of data for hundreds of patients, all of which will have taken the drug for between 96 and 144 weeks. Anavex will tell the FDA, "With all this data, please consider Blarcamesine for BOTH accelerated and for regular approval."
I imagine this data bomb will drop in early 2024, but I have been very wrong before about when data is dropped, so beware.
If I am correct, FDA approval may occur as early as spring or summer 2024.
The EU approval process has already begun, and that decision may be made in 2024, perhaps spring or summer if the EU prioritizes its 7 million dementia patients.
With dementia care costing hundreds of billions of dollars in direct and indirect costs for EACH the EU and the USA annually, approving Blarcamesine a month earlier than later could save tens of billions of dollars for the Western, democratic world. That's a major productivity boost for economies with enormous budget deficits burdened by elder-care.
Considering Leqembi costs $26,500 per patient, plus 5 MRIs and 26 IV-infusion office visits each year, the H.C. Wainwright price target announced today of $54 per AVXL share seems conservative. Blarcamesine will undercut Leqembi on price and will be far safer than Leqembi. No IV-infusions and no MRIs and no brain bleeding.
Most of all a slowing down of cognitive decline the likes of which has never been matched in any drug trial, as well as the first drug ever to demonstrate brain volume preservation.
And even the shorts will agree, the tens of millions of lives transformed is the greatest reward of all.
Addendum: More on the ATTENTION-AD OLE and the Parkinson's Dementia OLE studies
Good news regarding the ATTENTION-AD study (from this week's cc):...we had extremely high rollover from the double-blind, placebo-controlled [drug trial] into the open-label ATTENTION-AD study. I think it was over 90%. And we have a large number of patients on this study. We even have the first patients who finished that study going over and requesting an extension of this extension by another year. So it became now a 144 week study for some patients. And thereafter, we also have patients which requested to be given the drug continuously, and we provided them the drug on compassionate use. So there's a high request for patients to stay on the study drug.
With 90% of the participants from the 2b/3 trial (which saw 508 participants) continuing on to the ATTENTION-AD OLE trial, it seems that the participants really believe the drug is effective. Further, the large number of participants may allow the OLE study to be used as a confirmatory study.
Many of those in the ATTENTION-AD study have already completed the 96 weeks, so Anavex may already have some clue as to how the drug performed. The participants themselves also have some idea, as they have all taken the drug for 22 months longer than before. And it seems many have asked to extend their participation by another 48 weeks or take the drug indefinitely out of compassionate use.
If you look at the Parkinson's Disease Dementia Phase 2, placebo-controlled, double-blind, randomized drug trial of Blarcamesine, you will see tremendous improvement and slowing of decline among its participants.
And then if you look at the Parkinson's Disease Dementia open-label extension study, you will see that the effect of the drug did not disappear after the initial trial. Participants steadily benefited from the drug during that OLE.
I expect the ATTENTION-AD OLE study to demonstrate similar effects: continued consistent beneficial effects of Blarcamesine. In fact, for the twenty patients that remained (even through Covid) for the entire 48 weeks of the Parkinson's Dementia OLE, the average and the median scores actually IMPROVED in four important categories.
Finally, Anavex has already conducted a 260-week OLE of its Phase 2a (not 2b) study. This included a small number of participants. Safety was good, and those taking larger doses of Blarcamesine saw greater benefit from the drug. Other than that, little could be concluded by this small study.
The Competition's OLE
Biogen did not have to include the Leqembi OLE results for their accelerated approval process, and three OLE participants died apparently as a result of Leqembi's brain-bleeding side effects. Cynically, that may be why the Leqembi OLE study was not considered by the FDA in the decision-making process; they wanted to quickly approve Leqembi without having to answer questions about patient deaths. The FDA, after all, was found by a Congressional investigation, to have held secret, undocumented and unethical meetings with Biogen in order to get their even less effective yet also dangerous Alzheimer's drug, Aduhelm, approved.With three people dying from Leqembi in their extension study, the FDA may be more interested in the safety data from the 96-week Blarcamesine extension study.
One of those Leqembi deaths happened after only 6 weeks of Leqembi use within the extension study; it's not clear if she had been in the placebo or the medicated arm of the original Leqembi study. The makers of Leqembi interestingly did not reveal the death of this woman (in otherwise good health) at a major conference presentation. Months later, Leqembi was granted accelerated approval by the FDA, which apparently knew about all three brain-bleeding deaths.
There have been no deaths caused by Blarcamesine even after five years of use by OLE study patients.
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Anavex Ja sagen med BIVI viser risikoen ved biotek.
BIOVIE havde ellers mod sædvane offentliggjort del data fra deres ellers lukkede og ikke afsluttede AD fase 3 forsøg og deres CEO har været på et par gang i forskellige medier for at promoverer disse tilsyneladende gode data.
Nu viser det sig, at der har været et stort rod i håndtering af forsøget på hele 15 sites fra det samme geografiske område.
Der påstås, at der f.eks var målt virksom stof i placebo patienterne, nogle af patienter havde allerede forsøgsstof i kroppen ved opstart af forsøget mm.
Enten er har det været komplet inkompetent håndtering koncentreret i et påfaldende område eller også har der været tale om bevist sabotage og underminering af et ellers umiddelbar positiv virksom stof?
BIVI falder naturligvis på sådanne udmeldinger, når man ikke kan stole på, at protokollerne er overholdt - trods at stoffet måske har en positiv effekt.
BIVI har kun penge til måske 6-8 mdr. endnu og kan ikke bare sådan lige starte nye forsøg, uden at skulle låne eller udvande aktien voldsomt, især ved nuværende kurs. De er nu helt i lommen på pengefolk eller evt. en BP, som måske bare køber dem for en slik!Anavex har modsat været næsten hermetiske lukket omkring deres AD forsøg og data, selv efter det var afsluttet og efter TLD.
Alle forsøg i de forskellige indikationer er blevet kontrolleret af eksterne myndigheder for overholdelse af protokoller ved dossering, bivirkninger mm. - og alle blev blåstemplet uden anmærkninger.
Vi ved også at 90 % af AD patienterne er forsat i OLE forsøget og nu ved vi også, at EMA har set de komplette data fra AD fase 2/3 og har opfordret Anavex til at ansøge om markedsgodkendelse i EU.
Det viser også værdien af en Peer Review, hvor man overfor offentligheden for verificeret forsøg og data.
Skulle der mod min forventning være brug for f.eks et opfølgende fase 3, så har Anavex 150 mill. $ stående på bogen til financering af dette.
Så ja - Anavex og CEOen har hverken haft medietække eller store armbevægelser - tværtimod, men har med grundig forarbejde, forskning og især med anvendelse nyeste innovative teknologier, som AI og DNA/genetik, kørt de forskellige forsøg helt efter bogen.
Det illustrer hvor vigtig det er at skrue protokollerne og udformningen af forsøgene, samt udvælgelsen af de egnede patienter helt rigtig sammen. Det koster og tager lang tid, men så er chancen for at nå i mål også langt større - hvis skidtet altså virker!
EMA mener i hvertfald, at de har set noget, som måske kan gøre en forskel for 7 mill. EU borger med AD.
Det er mere end ca. 20 år siden at første og hidtil eneste stof - Donepezil, med bare en lille effekt er blevet godkendt i EMA (EMA har afvist de i US godkendte fra Biogen og LLY - manglende effekt og store bivirkninger).
Kan Anavex og Blarcamesine (2-73) forsat bekræfte alle de data vi har set hidtil, så tror jeg at EMA med stor sandsynlighed tildeler en markedsgodkendelse i løbet af 2024.
Når Anavex indsender ansøgningen på EMA´s opfordring, så må forvente at få oplyst - tilbagemelding fra EMA, om Blarcamesine bliver behandlet standardmæssigt eller efter et accelereret forløb.
Dette vil give et vink om, hvor overbevisende EMA ser resultaterne!Vi må bare afvente og følge udviklingen, men jeg har en rigtig god fornemmelse og er overbevist om, at Anavex når i mål!
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På seneste kvartals Conference call begrundede deres CEO ansøgningen til EMA med at mange at studiets patienter er i Europa, og at EMA arbejder langsomt.
Giver det mening?
Det kan vel være ligemeget hvor patienterne befinder sig, og det gælder vel om at få et produkt på markedet hurtigst muligt... -
Nej det var noget sludder det sidste. Men det giver god mening med at pts er delvist rekrutteret i EU.
FDA plejer at ville have forsøg i US, når de skal godkende noget. Så stadig tilbage og se om de kan undskylde sig fra ikke at tage ansøgning om godkendelse.
Det med at EMA er sene i behandling er korrekt, men ikke at det er en årsag til at søge først her - det er sludder.
Men måske et forsøg på at undskylde overfor andre myndigheder ?
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Anavex Shorterne har reduceret fra 18.614.000 til 18.119.000.
Samtidig skulle nogen dog i dag have lånt de 500.000 aktier, som var tilgængelig, formodentlig med det formål at smide dem på markedet og presse kursen ned - hvilket er stadig er muligt, når omsætningen endnu er relativ beskedent.
Synes dog shorterne lever livet farligt, især efter EMA er kommet ind i billedet og forventninger om kommende nyheder de næste uger, måske dage.
Anavex er rykket en liga op med EMA og må alt andet lige tiltrække nye investorer - store investorer kan være lige så grådige som hedgefondene, så det kan blive noget af en kamp!
Hvem vil sælge 18.000.000 aktier til shorterne på nuværende kursniveau, samtidig med at mange ønsker at købe aktier ved forhåbentlig gode nyheder?Ja det med EMA og begrundelsen om en længere behandlingstid af processen, tror jeg ikke på er den reelle årsag.
Det giver god mening af mange andre gode årsager, men uanset vil det ligge et pres på andre myndigheder, at EMA har lukket Anavex ind i varmen. -
En artikel som denne lægger pres på shorterne:
https://finance.yahoo.com/news/wall-street-analysts-see-468-145513955.htmlMin fornemmelse er at de må bruge deres krudt nu for at holde kursen nede.
Lidt flere nyheder og de dør.
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Anavex Illustration over hvor langt Anavex er i processen med EMA.
Fra IHUB:
Viser hvor langt Anavex er i processen med EMA.
Mit bud er, at der har været afholdt måske 3-5 møder med EMA, før vi fik nyheden om, at EMA opfordre Anavex til at søge om fuld markedsgodkendelse i EU, efter de rammer/ retningslinjer EMA og Anavex er blevet enige om.
Et bud kan være en indsendelse af ansøgning om 1-2 mdr. og et svar fra EMA om accept og evt. behandling som alm. eller acc. procedure ca. 1-2 mdr. efterfølgende.
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Fra shake it up show i Australien - de oplyser, at de støtter opstart af PDD trial med Blarcamesine i første kvartal 2024 med 50% finansiering.
Clyde Campbell & Vicki Miller | The Shake It Up Show
Listen to Clyde Campbell & Vicki Miller from The Shake It Up Show. On this week's episode, we are joined by Chief Executive Officer of Shake It Up Australia Foundation Vicki Miller and founder of Shake It Up Australia Foundation Clyde Campbell to talk about the incredible work they have done this year, and the research projects on the cards for 2024.Shake It Up Australia funds ground-breaking research that aims to slow, stop and cure Parkinson’s disease. And they need your help! To support Shake It Up’s vision of a world without Parkinson’s, head to shakeitup.org.au/podcast to get involved. Together, we can find a cure.
(shows.acast.com)
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Anavex Påtænker en nytråd ved enten AD eller RETT nyheder.
Jeg vil ikke bestemme om der skal startes en ny tråd eller ej, men har påtænkt at starte en ny tråd ved en ny markant milepæl.
Dvs Peer Review for AD eller RETT fase 3 data eller lign.
Starter ikke en ny tråd pga. en vilkårlig kursstigning.
Det står dog andre frit for, hvad man kunne tænke sig.
Som PI skriver, burde det være meget nemt at finde denne tråd?Positiv udmelding fra Shake It Up Foundation vedr. snarlig start af Parkinson i AUS.
Formanden er en af to brødre, der ejer en større Robot virksomhed.
Han har desuden levet med Parkinson selv i en del år nu, så motivationen og midlerne er i den grad til stede.Vedr. en evt. FDA ansøgning, så nævnte Missling på sidste CC, at FDA nok ville have OLE forsøget fra AD fase 2/3 inkluderet i en evt. ansøgning.
I teorien ville vel ikke være noget i vejen for, at kigge på 52 ugers data fra juni i år, samt data fra fase 2/3 forsøget. Her ville man så kunne indsende næsten 2 års kombineret data til FDA - vi ved jo at over 90 forsatte i OLE, som ellers først er afsluttet juni 2024 efter i alt 96 uger.
Dette OLE forsøg er iøvrigt nu også forlænget til 144 uger.
Lecanemab blev til sammenligning godkendt på grundlag af 18 mdrs. data.
Lige som med EMA, fik vi først oplyst efterfølgende, at Anavex havde haft flere møder med myndighederne, så vi ved reelt ikke hvor langt henne Anavex er tilsvarende dialog med FDA? -
Lidt om problemerne for Alzheimers lægemidler
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Anavex AbbVie køber Cerevel Therapeutics for 8,7 milliarder $!!
Af nedenstående pipeline har de to igangværende fase 3 forsøg i Parkinson - resten er i fase 1 og lidt i fase 2.
Intet er godkendt endnu og hvis deres fase 3 i Parkinson skulle vise positive data, så snakker vi en markedsgodkendelse om tidligst 2 år!
Selskabet er så lige blevet købt til hele 8,7 milliarder $!
Til sammenligning er Anavex jo meget længere fremme og er i dialog med EMA om en markedsgodkendelse i en langt større indikation med Alzheimer ifht. Cerevels Parkinson - derudover har Anavex også afsluttede RETT fase 3 forsøg + Parkinson og resten af deres pipeline!
Giver en ide om, hvordan Anavex casen kan udvikle sig, hvis de når i mål!
Et evt. opkøbstilbud på Anavex burde sammenlignet med Cerevel, ligge betydeligt højere!
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