Anavex og CNS
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Vi er sikkert mange der krydser fingre.
Godt du gør opmærksom på risikoen i biotech. Det kan være en voldsom oplevelse, hvis det går galt.
Men en oral præsentation er ikke fremlæggelse af noget der ikke duer. Så helt galt går det næppe.
Pøj pøj til alle.
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Solsen,så sandt,så sandt.Da Bioporto sidste gang forsøgte sig kostede det mig en mindre formue på 1 minut
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Jo, jeg er formentlig forholdsvis ny i gamet i forhold til flere af jer, men har da allerede brændt fingrene flere gange. Senest på SAS-COVID19-kombinationen.
I forbindelse med pandemien har jeg dog satset langt mere på biotech. Dét velvidende, at man i bioetch ofte vinder eller taber stort.
... og man kan ikke vinde hver gang. -
Jeg vil også takke Tasso1 en gang mere. Du ledte mig på sporet af Anavex og har fulgt dine posts og andre sites vdr AXCL for ca 1 år.
Det har overbevidst mig om at Anavex er potentielt banebryderne indenfor mange områder indenfor hjerne sygdomme.
Jeg har satset meget voldsomt må jeg indrømme men hvis man ikke satser nogle gange, tjener man heller ikke de store penge og hvis jeg mister +75% i værdi af min investering i AVXL er det bare ærgerligt men det vil ikke ændre min livsstil men jeg må så vente 1 år med at købe en ny bil, men det klarer den gamle bil sikket fint, ha-ha.
Jeg er nu ret sikker på at vi har en vinder her.
Held og lykke til alle de stakkels mennesker med disse uhyggelige sygdomme og os AVXL aktionærer. -
Anavex Ctad præsentation - alt ser super ud!
Se side 15 - 20.
Her måler de forbedringer i alle målepunkter!
Skal lige tygge materialet igennem, men alt ser umiddelbart super ud! -
Nogen der kender hende her? JskSrs på twitter @juliaskripkaser ! hun har lagt nogle kritiske bemærkninger ud på twitter, om at anavex har plukket i resultaterne, nogle med mere forstand end mig på emnet, der kan tjekke om hun har hold i påstandene?
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Anavex - CTAD
Har nu studeret de væsentlige punkter igennem - og må siger, at jeg har svært ved at finde noget negativt!
Dosis afhængig og med lille usikkerhed ser man markante forbedringer i forhold til placebo på alle områder - og uden bivirkninger.
Tror markedet har brug for en saglig analyse i de kommende dage fra en eller flere analytiker - f.eks. fra Parkinson News Today eller andre.
Tror simpelthen ikke markedet forstår det signifikante i resultaterne.
Jeg ved ikke hvad man mere kan forvente - 2-73 viser en tydelig effekt efter min mening.
Tror også, at der er en kombination af short inddækning og gevinst hjemtagning, eftersom kursen er steget meget den sidste tid.Mit syn på casen har ikke ændret sig!
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Kender hende ikke, men kan se at Adam Feuerstein og Andy Biotech er blandt hendes twitter følgere. Hendes twitter tråd og kritik minder meget om det man ofte kan læse hos Feuerstein. JKS hæfter sig meget ved, at AVXL kun har valgt at måle i forhold til 2 af 11 PDD målepunkter, og slutter herudfra at man nok har fejlet i forhold til de 9. Det har hun vel overhovedet ingen belæg for at slutte, og det jo rent faktisk godt være tilfældet at AVXL alene har valgt at vurdere i forhold til de 2 af de 11 målepunkter.
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Tak for detektivarbejde Thorkild01. Så må vi se hvad de finder på af kritik, når vi forhåbentlig snart får nogle positive RETT resultater
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Tasso1
Tak for din indsats,imponerende stykke arbejde du har præsteret.Er enig i din konklusion.
Mvh -
Ja ja og øv øv, det sgu en tynd kop te..... desværre fulgte jeg ikke min mavefornemmelse i går, og solgte min ellers fantastiske swing position, det havde ellers være et super salg i 7,3 $- og derefter genkøb i 5,5 $.... op på hesten igen, disse data skulle være en ekstra sidegevinst, i stedet for, blev det en mavepuster....
og lidt tyndt at den kan dykke så meget på den volume,
og en skribent med 8 likes, og lige så mange følgere... -
Anavex Udmærket gennemgang fra IHUB.
Kan tilslutte mig analysen og mener, at kursen nok skal rette sig igen den næste tid.
Slides fra link længere oppe i tråden.
Resultaterne fra RETT US kan heller ikke være langt væk.This write-up serves as an overview for Anavex's PDD results from 6 Nov 2020. Included I mention aspects of the slide presentation that I believe may be currently overlooked by investors and hope to provide some context while you read along.
Slide 11: Even in the subtitle Anavex couldn't help but mention use of their 'oral capsules'. As we know, this is the least invasive method of providing a drug and does not require any specialized equipment or hospital visits. Notice under 'key primary and secondary endpoints' the motor endpoints to include the most titillating actigraphy monitoring. I will briefly mention significance on this later.
Slide 15: Some have already gone online to tout the presentation as absurd due to 'cherry-picking', at first glance it would be easy to confuse retail investors with this statement. On slide 15 we see an overarching view of ALL patients (SIGMA 1 carriers, non-carriers, placebo, 30-mg, 50-mg) and the results of the Episodic Memory count. You will notice that as a whole, the placebo group declined from baseline over the time period. Its now important to carefully distinguish between the 30-mg and 50-mg effects.
- the 30-mg DECREASES NEGATIVE score in episodic events. Basically, 30-mg in the entire patient population virtually halted decline.
- the 50-mg INCREASES POSITIVE score in episodic events. The entire 50-mg patient population IMPROVED as a whole over baseline. From placebo to 50-mg means, the improvement is a whopping 202%.
Slide 16 suggests that the PDD trial and MCI-AD diagnostic facets are all directly comparable. That is to say, you can expect the phase 2/3 AD trial to have similar results to the PDD cognitive data. I will talk about this a bit more in a moment.
Slide 17 is really interesting. In slide 17, they begin cherry picking the patient subgroups (total population [132] on the left and SIGMAR1 WT carriers on the right [87]). Notice blue bars specifically on this slide. Most significantly, notice how the week 14 blue bar on the left (66%) is increased in the WT populations week 14 blue bar on the right (74%). This implies that by week 14, the SIGMAR1 WT carriers had an 8% greater benefit over non-carriers. Notice the same blue bars for week 8, there is only a 2% difference there. This is proving two things: the benefit of being a carrier INCREASES AS TIME GOES ON and that there is a noticeable difference between SIGMAR1 carriers and non-carriers to begin with. This validates previous trial data and I am VERY interested to see if this effect (2 to 8%) increases even more in the continuation study.
Slide 18 shows as a whole, SIGMAR1 WT carriers on the drug had a statistically significant (0.05%)improvement over placebo for episodic memory counts. In fact, the improvement noted virtually ceased decline as is evidenced by a 600% reduction... notice that this increase is for mean population, and that some SIGMAR1 carriers actually improved... as was similar in the 32-patient AD study.
Slide 19 and 20 should be looked at as a combination. On slide 19 you can see how minimally complex tasks and complex tasks are accomplished (by time in seconds) for four subgroups. These groups are the young, the old, Parkinson's patients, and Alzheimer patients. Once again, Anavex couldn't help themselves to a big circle and a gigantic box noting an unmet need in Parkinson and Alzheimer's. See how much longer it takes for these diseased minds to accomplish tasks. Slide 20 is where things really heat up (note that slide 20 is in milliseconds and I convert them to seconds to compare to slide 19). This shows two charts comparing SIGMAR1 WT carrier reaction time to placebo groups in two separate reaction time tests. On the left you have the 'choice reaction time' and on the right you have the 'digital vigilance reaction time'. It is important to recognize that slide 19's data is based on 'choice reaction time', so the left chart is 100% comparable.
- Left chart: decline of 5 seconds from baseline for SIGMAR-1 dosed groups, and a nearly 29 second decline from baseline for placebo group. This constitutes a huge 474% reduction in decline. You also see that some patients with SIGMAR1 WT reversed effects and improved, not just reduced decline.
- Right chart: decline of 0.00551 seconds from baseline for SIGMAR-1 dosed groups, and a 0.05054 decline from baseline for placebo group. This constitutes an ASTOUNDING 818% reduction in decline. Likewise, you see that some SIGMAR1 WT reversed effects and improved, not just reduced decline. And they accomplished this with an EXTREMELY significant effect of 0.008%
Slide 21 is significant of course because it details effects on sleep. Despite a marginally significant improvement of 0.054%, it is important to look at other Anavex 2-73 studies (AD study, Rett studies, preclinical), and you see that sleep is very clearly aided by Anavex 2-73. What strikes me as interesting is the mention of REM sleep. This is the portion of sleep where you dream, and is also known to be the sleep needed in healing.
Slide 22 alludes to penetration of the blood brain barrier (BBB) with bullet 3. It is interesting that bullet 2's dropout stats are virtually the same for both the active cohort and the placebo cohort. This, combined with bullet 1, indicates that patients from both cohorts likely dropped out for reasons completely separate to the actual dosing. Parkinson disease dementia is rough on these individuals and COVID-19 likely exacerbated a lot of issues endured by these patients. One that comes to mind is depression. I am very interested to see quality of life data on these patients.
Slide 24's 3rd bullet is of interest. Again, Anavex mentions that PDD outcomes will likely be similar or at least comparable from PDD - AD studies. We actually see this throughout the presentation, I will make a closing remark encompassing that thought.
Slide 25 in the first bullet mentions 'PDD/PD'. Isn't it interesting that they included PD. PD of course focuses more on the motor functionality of the disease. It seems to me that the endpoints located in bullet 3 (MDS-UPDRS and actigraphy) have ALREADY shown to researchers a clear improvement to motor impairment, which prompted funders (MJFF and SIUF) as well as regulators/trial initiators to branch out to a PDD/PD trial. "DATA WILL BE SUBMITTED TO THE U.S. FOOD AND DRUG ADMINISTRATION TO SEEK REGULATORY GUIDANCE'. Isn't it interesting that the PDD PR in October made use of buzzwords and sensory language found in the TGA PA guidance and the FDA AA guidance? I will let you make your own assumption here, but it is my opinion that Anavex is at least SEEKING accelerated approval. The SIUF PR not mentioned an actual PD trial phase number (3 vs. 4) seems to lead credence to that. Note that accelerated approval does not need to be granted and the next trial could very well be a phase 3. Make your own assumption, do your own DD.
As a final note, take a look at slide 30 (old 32-patient AD data). Look at how the green lined super responders barely decline and in fact, some improve. Now go back up and look at slides 15, 18, and 20. Do you notice a striking similarity? Anavex is absolutely paving a remarkable case in this proof-of-concept which merges multiple trials, and ground breaking precision medicine/genomic sequencing data (some ongoing). Someone with an agenda could say that the trial data, and while this is partially true, it doesn't share the whole story. Slide 15 shows the entire patient population. The other slides show SIGMAR-1 WT to placebo. SIGMAR-1 carriers are 80-90% of the population. These 'cherry picked' charts do in fact show more of the holistic story than some of these posters would try to have you believe.. they have an agenda and are trying to confuse retail investors.
The data in this presentation is overwhelmingly positive and warrants an investment in Anavex Life Sciences Corporation (AVXL). As always, please do your own research and make your own conclusions.
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@TDT123: Desværre er jeg nødt til at værre enig.
Meget skuffet over dagens kursfald.
jeg kan ikke rigtigt finde ud af om resultaterne er gode elle ej, nogle siger at de er rigtig gode, andre siger at de er: hmm.
Jeg har stadig profit, men det skrumper meget, rigtig meget.
Jeg skal lige tænke over hvad jeg skal goerre her i weekenden.
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Vi har intet på market der afhjælper parkinson, så derfor burde selv svage data være et plus, med svage mener jeg noget bedre end placebo ( siger ikke de svage )
Dette var jo et ekstra forsøg/skud i bøssen, udover de andre anavex køre, så regnede slet ikke med at market ville reagere så voldsomt på disse fine data ( som jeg fatter det ) .. så med bare en lille forbedring, er det jo et stort plus, da der ikke findes andre alternativer/ jeg fatter det ikke... -
Vi er formentlig en konkurent mindre nu, Biogens Aducanumab blev nedstemt med 1-8 af FDA rådgiverne!. Dagens tab er "nederen" men som jeg tror du TDT123 har skrevet på et tidspunkt, så går vi ikke efter 6 eller 8$ her, men gerne 40+ på den lange bane med Anavex.
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Jeg forestiller mig, at inhabile eksperter kommer med deres vurdering af resultaterne de næste dage. Hvis der virkelig ses forbedring af REM søvn forstyrrelser, som kan være et af de mest karakteristiske og endvidere første symptomer ved parkinson, er det helt fantastisk. Jeg går ud fra at forbedringen måles fuldstændig objektivt uden patientens egen vurdering.
Epidemic memory: kan ikke helt forestille mig, hvordan det måles. Men hvis seriøse analytikere siger god for, at der ses forbedringer, så er det da vist kun mafiaagtige tilstande, der kan hindre godkendelse af produktet. Men hele forløbet, hvor man føler selskabet er uden for rækkevidde og ikke kommer på banen med resultater, giver i hvert fald mig en kæmpe stor skepsis med hensyn til fremtidsudsigterne. Lidt af en øjenåbner. Hilsen fra en meget lille investor.
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