Der bliver her åbnet for tre nye forsøg med 3-71 med begyndelse i 2022 - som jeg læser registreringsforsøg.

Der bliver mange nye forsøg åbnet i 2022 !

Ingen SAE i 5-200 mg. Met primary amd secondary endpoint.

God start til ny tråd.

Sandhedens time - kl. 20.30 - måske pr. kl. 13.00!!!

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Kan se man skal installerer ZOOM for at se med.

Kunne måske være et godt tidspunkt at starte en ny tråd 2022???

Spændende !

Det er ikke lykkedes ham, at få Seekingalpha at udgive det endnu. Men han arbejder på at det sker her eller andets steds.

Han mener, at have fundet ud af noget interessant: https://investorshub.advfn.com/boards/read_msg.aspx?message_id=167430663

Spændende hvad den næste uge bringer dels fra ham og Anavex på de to konferencer de deltager i.

God lørdag aften.

Det virker både som en styrkelse af organisationen og forberedelse til næste skridt mod en egentlig godkendelsesproces.
Det er må også skulle ses som et stort klap på skuldrene for veludført arbejde af den igangværende proces.
Omvendt ville dette skridt virke ulogisk, hvis man havde set eller troede på dårlige resultater.
Igen - selvom Anavex ikke skulle have kendskab til f.eks. Avatar data endnu, så må der løbende have været feedback fra de forskellige sites fra de forskellige indikationer - især også fra de åbne OLE forsøg.
Der må være mellem ca. 500 og 600 patienter, der faktisk får 2-73 på nuværende tidspunkt, på tværs af alle indikationer og stadie i forsøgene (inkl. OLE og over en flerårig periode) - det kan næsten ikke undgås, at lægerne og Anavex har kunnet se om patienterne har haft gavn af behandlingen i et eller andet omfang - eller ikke.

Så er vi parate til at vende bussen

Men biotech får mega tæsk lige nu.

Just a moment...

(ih.advfn.com)

Endnu en konference!
Ville nu hellere foretrække de lovede data.
Omvendt får vi data fra Avatar og 3-71, som vi var lovet omkring "end of year", så stillede Anavex nok ikke op til hele 2 CC´er her den 10. og senere den 13. januar på JP Morgan , hvis Anavex forventede dårlige resultater.

HC Wainright er kun tilgængelig via. on-demand nu på mandag, så de kan vel ikke komme med noget, som ikke er offentlig tilgængelig inden.
Dvs. man kan måske lidt naivt håbe på, at vi får data i morgen torsdag eller fredag?
Med de konsekvent forsinkelser og udskudte milepæle fra Missling, så ville jeg dog ikke satse hele bondegården på resultater inden weekenden.

Bare de er gode, er tidspunktet sekundært - om end lidt irriterende, at det altid går noget længere tid end udmeldt.

Hele det indeks Anavex er i (XBI), blev ramt i går - så Anavex blev trukket med ned.
vi skal have gode resultater for at blive afkoblet - bare en del af spillet!

"is pending FDA approval for research in FXTAS"

Hendes ordvalg har flere gange undret mig. Tidligere har hun udtalt, at hun ikke vidste om stoffet var godkendt eller lige var ved det. Nu siger hun "which is pending FDA approval" - hvilket jeg opfatter som afventer approval.

Mig bekendt er der ikke søgt approval endnu, idet der ikke er færdige forsøg at søge på.

Nå det kan være en tilfældighed, men alligevel mærkeligt af en professor.

Vi slap med PAL skattesmæk i stor stil i år. Jeg tager gerne tæsk til næste år

Godt nytår.

Ja data kommer nok før den store konference i januar.

Godt Nytår til alle her på tråden.

https://www.dovepress.com/fragile-x-premutation-medications-therapy-and-lifestyle-advice-peer-reviewed-fulltext-article-PGPM

Another new treatment which is pending FDA approval for research in FXTAS is Anavex 2-73, a sigma 1 agonist that works in the endoplasmic reticulum and mitochondrial interface. It can reduce oxidative stress, alleviate calcium dysregulation in neurons and improve mitochondrial function which is greatly needed in FXTAS and in other disorders.127,128 Anavex 2-73 also helps other cellular dysfunctions including proteostasis, autophagy and neuroinflammation that are present in neurodegenerative and neurodevelopmental disorders.129,130 It has been efficacious in animal models and human studies in Rett syndrome (unpublished), studies in Alzheimer Disease, in Parkinson's Disease Dementia (unpublished) and most recently in rescuing hyperactivity and other behaviors in the KO FXS mouse.127,131,132 Soon controlled trials of Anavex 2-73 will be studied in those with FXTAS.

Randy Hagermann er, som tidligere beskrevet, en af de førende kapaciteter indenfor FXTAS/Fragile X og er meget stor fan af 2-73.
Som ansvarlig for sites i RETT US forsøget, har hun tidligere udtalt sig om den overbevisende effekt hun så i RETT pigerne og senere også for de, der efterfølgende skiftede over i OLE studiet fra placeboarmen.
Hun udtalte ved en anden lejlighed, at det Fragile X forsøg, som omtalt i artiklen burde være startet i går.

• ja hun ville endda selv tage 2-73 mod aldersrelaterede sygdomme, når det kom på markedet!

Nå - stadig ingen data fra Avatar - håber godt nok Missling trækker den til efter 1. januar 2022, når vi er kommet så langt hen på tiden.
Vil hellere betale 17 % i afkast af aktier i kurs 17 $ - med aktier solgt i kurs 35 $ i januar 2022. ( Aktiesparekonto )
Skatten skal jo betales i sidste ende i 2023, men så kan pengene jo arbejde et år længere og samtidig minimere risikoen for ikke at have betalt afkast af en aktie, som måske bliver mindre værd i løbet af året.

• håber det giver mening!

Skulle der komme data, vil det normalt blive fulgt op af en CC - og det gør man vel ikke den 31. dec?

Godt og lykkebringende ( indbringende ) Nytår!!

En PR i dag eller i morgen før market åbner kan jo ændre billedet total...

Men det ser noget sløjt ud....

Nåååå:

Godt nytår alle

Mvh

Torben

https://piotrpeterblog.com/2021/12/28/the-trouble-with-avatar-avxl-blarcamesine-rett-syndrome/

Men iflg US RETT forsøget kom RBSQ endpoint i mål med en p-værdi på 0,048. Det er i min optik en meget lille margin til de 0,05, som er grænsen for signifikans under normale omstændigheder.
https://www.anavex.com/post/anavex-life-sciences-announces-anavex-2-73-meets-primary-and-secondary-endpoints-in-clinical-trial

Derfor og med tanke på noget doseringsmæssig i Avatar må vi have muligheden for ikke succes åben. Med det ikke sagt, at slaget er tabt, men blot at succesen udskydes.

Missling kender ikke data meget før vi kender topline.

Det bliver spændende.

Først ønskes I lige en rigtig god jul!!

RETT US forsøget havde endnu færre patienter end Avatar, men trods det, var der signifikant positiv respons på samtlige parameter og med meget lille p-værdi (usikkerhed).

Det er dog bemærkelsesværdig, at Anavex ikke har meldt størrelsen af dosis af 2-73 ud, kun at den er større end ved RETT US.
Denne disposition må være sket efter aftale med FDA.
Tror nærmere, at Anavex forsøger at finjusterer dosis ifht. de forskellige typer af RETT patienter - vægtmæssig, MRNA, sværhedsgraden af sygdommen i den enkelte patient mm.
De forsøger formentlig at knække koden, hvorfor forskellige patienter skal have forskellig dosis - for at opnå den optimale behandling.
Dette vil ikke kun have betydning for RETT indikationen, men formentlig også indgå i protokollen for de andre planlagte indikationer, som Anavex har annonceret snarlig opstart af nye forsøg i.

Alt er lidt gætværk, indtil vi har resultaterne fra Avatar - tror dog, at der er en velbegrundet disposition bag de valgte protokoller - med FDA på sidelinjen.

Der er rigtig mange gode skribenter på IHUB og de fleste er også meget positive på Avatar - men ingen ved reelt noget konkret før vi får data.

IGEN - Missling stiller simpelthen ikke op på JP Morgan den 13. januar med dårlige resultater fra Avatar i bagagen!!

Vi afventer forsat!

Biostockclub er en anden af de skrappe drenge(de har en del) på Ihub's tråd om Anavex.

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=167262848

Biostockclub Monday, 12/27/21 12:22:39 AM
Re: tradeherpete post# 341254 0
Post # of 341262

Merry Christmas, tradherpete and all,

You already know what I think!

Alzheimer's is a mystery with 2 prominent clues for detectives wishing to solve its "crime" element:

First, there's physical evidence: the presence of amyloid beta. - That's like a hammer at the scene of the crime. It's there but we can't account for its presence...is it the cause of death, the murder suspect, the murder weapon, or the motive, or just an innocent bystander?

Second, there is this incredible pattern which science doesn't appear to be including in reasoning the solution to the puzzle/ mystery.
The first thing a detective would do when trying to determine sequence of events at multitudes of "serial kills" (in this case, AD) would be to look for a pattern used by the "killer" or "killers". Is it random or can we narrow the "suspects" down based on the victims' circumstances?

Yeah, we've been over this before. Whatever causes Alzheimer's must not only impair brain function (cause of death) but must also have a selection chauvinism for females to the tune of 2:1 when compared to males (gender calibrated at birth, sorry, no identity proclivity games here, can't fool Mother Nature).

Science/Big Pharma got this wrong for 30 years by looking at the physical finding and trying to pin the blame on it and make it the cause. Bosh!
Detectives and deductive reasoning will get closer: work backwards from the "victims" - MUCH LARGER CLUE than the high drama surrounding amyloid beta...(if Amyloid Beta is the Lee Harvey Oswald of CNS victims, then, Biogen is Jack Ruby, and the FDA and the Alz advocacy groups are the Warren Commission - it's THAT obvious).

Ask yourself the litmus question when considering cause of disease as a drug-able target for treatment/cure MOA in AD:
Would this account for the gender disparity?

P. Gingivitis and other bacteria would be candidates in my book if the sponsors of the trials testing the drugs which treat these (bacteria/viruses) can show the correlation between females carrying the bacterium/virus (plural, if there are many brain infections causing the inflammation) TWICE as often as their age correlated male counterparts. Everything I have read suggests that women, in general, practice superior dental hygiene to males as a habit. If not superior, at least equal to males, which would give this "suspect" a reasonable/plausible "alibis" for not being the culprit in these serial crimes...we can't account for them being in 2/3's of the victims' mouths/systems at the time when Alzheimer's begins to develop in brains and that predates the manifestation by decades. Really? An infection taking that long to become virulent?
Contemplate the soundness of the timing...people can have p. Gingivitis throughout life, even young adults/middle age, both genders...why do predominantly old females manifest neuronal death/impairment and dementia at twice the rate of older males after an infection which needed to be increasing plaque buildup for decades?
Get that answer and you get the prize (unless you're Biogen...in which case the "prize" for discovering the Holy Grail of CNS diseases turned out to be loss of share price, loss of employees (looking at you Sandrock, and coming layoffs), expert neurologists denouncing your drug's efficacy on the national stage, Congress and Fed govt (US) investigating your approval path, lot of bad press - scandals for FDA - Medicare, Medicaid walking away like it's a live grenade...hell, even the VA turned this down - someone in Vegas got rich betting AGAINST Biogen. Warren Buffett dumped the stock, Europe and Japan declined (not even politely) and it now looks as though Biogen will NOT be able to carry out the confirmatory ph 4 because they can't get 1600 participants willing to pay - and that's at half price.
Yes, LLY is announcing their intent to apply for approval of another plaque remover, as is Roche, but that's to increase current share price. They have no intention of filing - that's the second half of the 1-2 punch and is for suckers...it (filing and approval) drains the gains made off the announcement(!) to file)).

You can't get to dementia from gum disease, sorry CRTX, you're about to hang an Innocent Man.

As for SAVA's MOA - filamin A malfunction causing amyloid plaque build up from misfolded proteins, let's have the gender connection. What causes females to have this expressed at a staggeringly higher rate in old age when compared with males or young folks? I find nothing that can lawfully implicate, let alone convict, the filamin A.

As for the Sigma 1 receptor, we have already discussed the fact that the most potent inhibitor of the S1R, on the planet, is progesterone. Since there is a correlation between females using contraceptive pills (beginning in the 1970's widespread, so females around age 20 average in 1970's would now be women in their 70's) and the current population afflicted with Alzheimer's. Contraceptive pills contained much higher doses of the hormones when they began (orders of magnitude) versus today's BCP's.
Add the correlation between countries who approved use of "the pill" and today's Alzheimer's population and one can see a perfect map overlay of where our "killer" was at the time of the crime.
Add in the fact that countries which never approved use of "the pill" have statistically significant lower AD rates today.
Include the knowledge that countries where diets are rich in turmeric (India and Southeast Asia) have lower rates of AD today as well - significant. It's noted that turmeric inhibits progesterone.
Compounding evidence: Women who have had five or more pregnancies are at increased risk for AD. Fact. But, pregnancies happen when you are young... and progesterone is produced to thicken the uterine lining, endometrium, as a nurturing environment for the embryo to best develop into a fetus.
So, when pregnant, a woman's progesterone level rises from 1.2 ng/mL to 300+ ng/mL. During the pregnancy, a woman could have her S1r's inhibited for 9 months. Five or more of these extended periods, where S1r is substantially inhibited, appears to increase the risk of Alzheimer's later in life. So, shutting down the S1r for extended periods multiple times during childbearing ages can be the culprit at the right place and the right time to create the conditions for proteins to misfold and demonstrate increased cognitive impairment later.
That's not just a random pile of facts or coincidences and it's certainly not magic or conspiracy. But, it does help explain a correlation between the S1r and the gender difference of Alzheimer's population we see right now.

Then, turn your attention to chromatin and look for gender discrimination there. Outta time for now - you got this!

Can't promise that S1r agonists will cure AD but if so, the gender "mystery" will have been solved (to my satisfaction). With other treatments - just not seein' it.

Healthy, happy, prosperous, 2022 to all.

Wish that Benny were here to usher in a new year with us.
A 12/31 11pm toast to the AVXL demons, rascals, and merry makers - aces, all! will be offered and in memory of those we lost.
Raise a glass wherever you are in solidarity:)

And, at midnight, drink to those whose afflictions might see some relief in the coming year(s) as soon as possible

2022 - a better year for all, I hope

Cheers!
Biostock
PS: FTR, I know, it's not a crime scene nor detective series, and they are all just biotechs doing trials and trying to develop drugs which pass trials which is a tricky business (got that tattooed) and promise I will be very careful, once and F'r All!:)

Men jeg håber og overordnet tror på gode data i Avatar.

Der er i øvrigt kommet nyt frem på Ihub, der tyder på, at deres pediatric vaucher ikke udløses, hvis Anavex søger godkendelse i Rett til voksne pts inden der søges til børn.

Det forhold er nok også baggrunden for, at Missling vil have stærke data i Avatar for, at han søger om godkendelse til voksne Rett pts. Vaucheren som fortabes ved ansøgning/godkendelse i rett til voksne anslås til at have en værdi på ca. $100 mln.

De sidste pts mangler, at blive rekrutteret i studiet i Rett-børn (Excellence). Jf facebook genoptages rekruttering i februar. Anavex vil sikkert gerne se Avatar resultater før dette sker så derfor kommer data meget snart og som Anavex lover omkring nytår.

Vi kan håbe, at data i Avatar er så gode, at der søges godkendelse. Er de ikke det må vi vente på Excellence og forvente, at Blarcamesine ikke bliver godkendt i 2022.

Det vil trykke kursen, men vil kunne være en suppleringsmulighed.