ANAVEX NY TRÅD!! FEBRUAR 2022 POSITIV AVATAR FASE 3!
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Det er en åben invitation FDA sender ud til mødet med Rett pårørende og andre interesserede d. 11. marts. Man kan tilmelde sig i linket herunder.
Så bliver det spændende at høre om der er alternativer til Anavex, som måske fungerer lige så godt eller bedre!
https://rettsyndromenews.com/2022/02/09/rett-community-perspectives-shared-online-fda-meeting/ -
Disse to professorer siger at RETT resultaterne er meget lovende.
Man behøver jo ikke at værre dybt inde i videnskaben for at tro mere på de to herrer end A. Frankenstein.
Den ene kommer fra et top universitet i Australien og den anden fra King's college London hvad der jo bare understreger "casen".
Blarcamesine Reduces Rett Syndrome Symptoms
Blarcamesine (Anavex2-73; Anavex Life Sciences Corp, New York, NY), once daily oral liquid doses of up to 30mg, demonstrated statistically significant red…
(practicalneurology.com)
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Anavex. BP har hele 1700 milliarder $ til opkøb eller partneraftaler.
Mange BP melder helt klart ud, at de stålsat går efter den næste investering og udvidelse af deres forretning.
Anavex med en MC på under 1 milliard $ og med en fremskreden case i nogle af de største områder indenfor CNS, må være et eftertragtet emne.
Håber ikke Missling sælger ud af guldet, men evt. kun indgår en attraktiv partneraftale, så man hurtigere kan få flere af indikationerne godkendt og hurtigere får opbygget et markedet.Husk CC i aften!
Webcast kl. 21.00 DK-tid
https://wsw.com/webcast/svbleerink67/avxl/2679350 -
Jeg vil høre specielt efter PD/PDD i aften. De har datapakken parat.
De har nu "eksperter" til at kigge på data inden de går til fda for en IND.
Håber at disse "eksperter" er mulige partnere, der byder sig ind inden protokollen aftales med fda.
En aftale her ville kunne give aktien den opmærksomhed de åbentlyst mangler.
En aftale med BP her ville også reducere risikoen for et fjendtligt overtagelsesforsøg.
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hejsa
jeg ved ikke om i har set denne artikel -
Anavex ... Jeg fangede ikke noget nyt i dagens CC.
De arbejder stadig med Anavex data og har ikke sendt noget til fda. Derfor ingen tid på et evt. møde omkring filing.
Ingen hints omkring forestående udliceseringer/partnerskaber.
Men det lyder stadig godt det hele.
Lidt mere tålmodighed.
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Anavex. God forklaring på de forberede endpoints i Avatar.
Danskeren 2014 fra IHUB
Beskriver det Missling ellers fint gjorde rede for på dagens CC.ACAD`s Trofinitide havde ingen effekt i voksne RETT piger.
2-73 RSBQ var på gennemsnitlig -12,5 i voksne piger mod Trofinitides kun - 4,5 i børn/unge eller ca. 3 gange større effekt - og så endda i voksne piger!! ( Jo større negativ score, jo større effekt )
Missling understregede igen, at man derfor havde store forventninger til Excellence.
ACAD har øget sin MC med 1,4 milliarder $ siden fase 3 data i december.
ACAD skal dele en evt. gevinst med Neuren.
Anavex har tabt 10-20 % siden deres fase 3 data - absurd?
Anavex skal ikke dele en evt. gevinst ved salg 2-73 med nogen!
Missling understregede igen Trofinitides omfattende bivirkning ( diarre og kvalme - mod ingen i 2-73!Bemærkede at selv under CC`en, var der næsten ingen handel - der var næsten brug for en hjertestarter for at holde liv i handlen.
Må bare erkende, at kun meget få tager notits af Anavex og casen - Endnu!Her 2014´s fine indlæg:
Anavex Life Sciences Corp (AVXL): CGI-I Anchored RSBQ AUC without the math...
Investor2014: CGI-I Anchored RSBQ AUC without the maths Well Missling is explaining it all again as I write and I believe he has got it right, but here is my att...
InvestorsHub (investorshub.advfn.com)
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Anavex ... Der bliver uddelt bøllebank til biotech og i særdeleshed Anavex de seneste dage.
Nu under $10.
Gode dage i lille plus og på dage med negativ stemning får den mega prygl. Mon ikke banditterne trykker på speederen disse negative dage.
På aktionærlisten er Goldman Sachs sammen med Morgan Stanley i fremmarch. Det er positivt.
Ikke nye oplysninger fra firmaet og meget stille fra deres side gør sit til, at vi ikke kan ramme en positiv trend.
Jeg holder ud og håber alle der har lyst til det også kan slå koldt vand i blodet.
Håber på nyheder omkring afsluttet fda møde og meddelelse omkring igangsat NDA ansøgning snarest.
Gerne også flere forsøg igangsat - ikke mindst Fragile-X som jo burde være igangsat sidste år. Det skylder de patienterne !
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Alle holder vejret med den geopolitisk uro. Det ene dårlige signal afløser det andet. Vi er midt i en orkan på aktiemarked. Hvis man ikke har solgt, skal det her morads bare rides af. Jeg har ikke solgt en eneste aktie i mit depot og styrtbløder. Jeg har dog tiden med mig og nægter at sælge med tab. Det er den perfekte storm efter 10 år med aktie fest.
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Anavex. Februar præsentation inkl. Avatar topline data.
Inkl. forklaring vedr. endpoints for Avatar.
Signifikant effekt i alt de har afprøvet 2-73 i.
Resultater fra tre fase 3 forsøg i 2022.
Bred og fremskreden pipeline i nogen af de største indikationer indenfor CNS.
Ingen bivirkninger - overstråler alle potentielle konkurrenter.
Store investorer øger deres andel.
Ingen gæld - 150 mill. $ på bogen.
MC = kun 750 mill. $!
Fratrukket likvider, er hele deres pipeline prissat til kun sølle 600 mill. $!!! - 3-71 alene er næste det værd!Prissætningen var ikke rationelt før - og nu slet ikke efter Putins vandvittige ønske om at skrue tiden 30 eller 100 år tilbage med ønsket om et nyt stort Rusland, der ( igen ) underkuer andre nationers suverænitet!
Manden er bindegal og opfyldt af indædt had til den vestlige verden - og det værste er, at selv herboende russer integretet i det danske samfund, stadig ser manden som et forbillede og stadig tror mere på russiske end vestlige medier!! ( noget svigerfamilie - troede ikke mine egne øre )
Hvordan kan den alm. indbygger i Rusland så se sandheden?Det er ikke andet for end at håbe på, at Putin "nøjes" med udbryderregionerne og dette er nok til han kan stoppe der, uden at tabe ansigt overfor det russiske folk og stadig virke som en stærk leder - tvivler desværre dog!
Vedr. Anavex ( og andre aktier ) så er det ikke andet for, end at ride stormen af - virker 2-73 som de fleste af os herinde tror, så får Anavex sin markedsgodkendelse uanset geopolitisk uro og vil gøre en investering ekstrem god i sidste ende.
Lige nu har jeg dog mest ondt af de stakkels mennesker i Ukraine!
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Anavex. FDA/NDA procedure og tidslinje.
Anavex samler nu alle data for RETT forsøgene og afleverer disse til FDA.
Dette kan måske tage et par mdr. før de så evt. laver en NDA ansøgning for 2-73 i RETT for piger over 18 år.Her et udmærket link med oversigt over processen.
https://www.fda.gov/media/97229/download
Selv med den hurtigste vej gennem systemet, snakker vi stadig 5-8 mdr. for en evt. godkendelse efter indsendelse af NDA - dvs. tidligst slut 2022/ start 2023.
Anavex har jo bl.a. Fast Track, der burde fremskynde processen.
Der er dog flere milepæle i form af flere møder med FDA undervejs og resultaterne af disse, som kan indikerer hvor positiv/negativ FDA ser på ansøgningen.
FDA kan bl.a. tildele BTD eller AA mm., som både vil fremme processen, men også vise, at FDA højst sandsynlig vil tildele en godkendelse i sidste ende.Vi kan ikke andet end at afvente - hele casen lever i bedste velgående og om kursen er 10 eller 30 $ er fuldstændig sekundært - især da Anavex har de finansielle muskler, der skal til, for at gennemfører hele processen de næste 5 år, uden at skulle udvande selskabet ved lån eller større salg af aktier.
Mange tanker til Ukraine!
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Anavex. Webcast den 16. marts. - Needham Virtual Neuroscience.\n\nhttps://ih.advfn.com/stock-market/NASDAQ/anavex-life-sciences-AVXL/stock-news/87501899/anavex-life-sciences-to-participate-in-the-annual\n\nEndnu et forsøg på at udbrede kendskabet til Anavex og især 2-73 - hidtil har dette dog ikke haft den umiddelbare store effekt - selv øgede kursmål preller helt af på prissætningen.\n\nWebcast den 16. marts kl. 14.00 DK-tid\nhttps://wsw.com/webcast/needham118/avxl/2274180\n\n\nFredag den 11. marts afholdes et åbent møde mellem FDA og RETT org. - Anavex er en af hovedsponsorene!\nhttps://rettpfdd.org/\n\nDer kan være delte meninger om sådanne arrangementer, en godkendelse af et produkt skulle helst være baseret på gennemarbejdede forsøg og ikke på måske enkelte forældres oplevelser af behandlingen med f.eks. 2-73 - men det ene udlukker jo ikke det andet. Så måske kan der komme lidt positiv fokus på 2-73 effekt i RETT, fulgt op af vellykkede forsøg.\nRETT US og Avatar var jo meget vellykket - uden det er afspejlet i nuværende kurs.\n\nDet eneste markedet åbenbart lader sig imponerer af er, når vi forhåbentlig får gode resultater i AD fase 2/3 sidst på året.\nOLE Parkinson på 48 uger med ca.132 patienter ventes dog afslutte i april - data herfra måske i juli.\nData fra Excellence burde også komme før AD - og udover dette evt. opstart af de forskellige annoncerede fase 2/3 - 3 i forskellige indikationer.\n\nTingene kommer når de kommer!\n\nEn hilsen fra de norske pister!
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Anavex. Iflg. dygtige TTTav66 fra IHUB får vi nyt fra PDD i næste uge - samt mere vedr. 3-71.\n\nPDD news next week. Anavex will have a poster presentation at AD/PD 2022, March 15-20: \nQuote:\nANAVEX
2-73-ANALYSIS OF MOVEMENT (MDS-UPDRS) AND COGNITIVE (CDR SYSTEM) PHARMACODYNAMIC-BIOMARKER OUTCOME MEASURES PLACEBO-CONTROLLED PHASE 2 TRIAL IN 132 PARKINSON'S DISEASE DEMENTIA PATIENTS \n\nJ. Kulisevsky1 , T. Fadiran2 , E. Hammond2 , C. Missling2 , C. Williams3 , F. Parmentier3 , M. Kindermans3 , M. Afshar3 \n1Universitat Autònoma de Barcelona, Sant Pau Hospital, Barcelona, Spain, 2Anavex Life Sciences, Clinical, New York, United States of America, 3Ariana Pharma, Clinical Analysis, Paris, France \n\nAims: ANAVEX2-73 (blarcamesine), a novel, oral, investigational SIGMAR1 was assessed for movement and cognition in patients with Parkinson's disease dementia (PDD) measuring motor and nonmotor complications (MDS-UPDRS) and cognition (CDR system) and pharmacodynamic-biomarker analysis including mRNA SIGMAR1. \n\nMethods: ANAVEX2-73-PDD-001 14-week study was an international, double-blind, multicenter, placebo-controlled Phase 2 clinical study. 132 patients with PDD were randomized equally to target doses of 30mg, 50mg ANAVEX2-73 or placebo. MDS-UPDRS, which is a validated global test for PD was assessed to evaluate various aspects of motor and non-motor complications, while cognition was evaluated with Cognitive Drug Research computerized assessment (CDR) system, which is an automated test battery validated for use in AD, PDD and other dementias. \n\nResults: MDS-UPDRS Total score improved significantly by -14.51 (p=0.034) for patients treated with ANAVEX2-73 high oral dose once-daily compared to placebo. The improvement is clinically relevant corresponding to a relative improvement of 18.9% over 14 weeks. Balanced and global improvements were observed: All MDS-UPDRS sub-scores Part I-IV improved with vast majority of individual items between >71% and >92%. SIGMAR1 mRNA expression significantly increased in ANAVEX2-73-treated patients vs placebo (p=0.035) and significantly associated with improvements of MDS-UPDRS scores and cognitive efficacy endpoints CDR system. \n\nConclusions: ANAVEX2-73 was generally safe, well tolerated and demonstrated dose-dependent efficacy for both motor impairment (MDS-UPDRS) and cognition (CDR system), which correlated with SIGMAR1 mRNA as a pharmacodynamic biomarker, respectively. These results support continued development of ANAVEX2-73 in PD and PDD as well as currently ongoing Precision Medicine biomarker-driven late-stage clinical studies in Rett syndrome and Alzheimer's disease. \n\nhttps://adpd.kenes.com/wp-content/uploads/sites/148/2022/03/ADPD22_-_LIST_OF_GALLERY_ABSTRACTS_FOR_WEB_January-5th.pdf\n\n\nAlso of relevance to Anavex and the MOAs of its drug candidates, both the inventor of Anavex 3-71(AF710B), Dr. Abraham Fisher, and the scientist responsible for much of its pre-clinical development, Dr. Ilya Bezprozvanny, will be giving symposium lectures at the conference. Dr. Abraham's talk will focus on activation of the M1 muscarinic receptor and Dr. Bezprozvanny's is on understanding the signaling functions of the Sigma-1 receptor: \nQuote:\nM1 MUSCARINIC STIMULATION OF POST-SYNAPTIC RECEPTORS FOR THE POTENTIAL TREATMENT AND PREVENTION OF COGNITIVE DECLINE \nhttps://cslide.ctimeetingtech.com/adpd22/attendee/confcal/show/session/30\nQuote:\nSIGMA-1 RECEPTOR - A ROLE IN NEURONAL SIGNALING AND NEURODEGENERATION \nhttps://cslide.ctimeetingtech.com/adpd22/attendee/confcal/show/session/51\n\nPDD news next week. Anavex will have a poster presentation at AD/PD 2022, March 15-20: \nQuote:\nANAVEX2-73-ANALYSIS OF MOVEMENT (MDS-UPDRS) AND COGNITIVE (CDR SYSTEM) PHARMACODYNAMIC-BIOMARKER OUTCOME MEASURES PLACEBO-CONTROLLED PHASE 2 TRIAL IN 132 PARKINSON'S DISEASE DEMENTIA PATIENTS \n\nJ. Kulisevsky1 , T. Fadiran2 , E. Hammond2 , C. Missling2 , C. Williams3 , F. Parmentier3 , M. Kindermans3 , M. Afshar3 \n1Universitat Autònoma de Barcelona, Sant Pau Hospital, Barcelona, Spain, 2Anavex Life Sciences, Clinical, New York, United States of America, 3Ariana Pharma, Clinical Analysis, Paris, France \n\nAims: ANAVEX2-73 (blarcamesine), a novel, oral, investigational SIGMAR1 was assessed for movement and cognition in patients with Parkinson's disease dementia (PDD) measuring motor and nonmotor complications (MDS-UPDRS) and cognition (CDR system) and pharmacodynamic-biomarker analysis including mRNA SIGMAR1. \n\nMethods: ANAVEX2-73-PDD-001 14-week study was an international, double-blind, multicenter, placebo-controlled Phase 2 clinical study. 132 patients with PDD were randomized equally to target doses of 30mg, 50mg ANAVEX2-73 or placebo. MDS-UPDRS, which is a validated global test for PD was assessed to evaluate various aspects of motor and non-motor complications, while cognition was evaluated with Cognitive Drug Research computerized assessment (CDR) system, which is an automated test battery validated for use in AD, PDD and other dementias. \n\nResults: MDS-UPDRS Total score improved significantly by -14.51 (p=0.034) for patients treated with ANAVEX2-73 high oral dose once-daily compared to placebo. The improvement is clinically relevant corresponding to a relative improvement of 18.9% over 14 weeks. Balanced and global improvements were observed: All MDS-UPDRS sub-scores Part I-IV improved with vast majority of individual items between >71% and >92%. SIGMAR1 mRNA expression significantly increased in ANAVEX2-73-treated patients vs placebo (p=0.035) and significantly associated with improvements of MDS-UPDRS scores and cognitive efficacy endpoints CDR system. \n\nConclusions: ANAVEX2-73 was generally safe, well tolerated and demonstrated dose-dependent efficacy for both motor impairment (MDS-UPDRS) and cognition (CDR system), which correlated with SIGMAR1 mRNA as a pharmacodynamic biomarker, respectively. These results support continued development of ANAVEX2-73 in PD and PDD as well as currently ongoing Precision Medicine biomarker-driven late-stage clinical studies in Rett syndrome and Alzheimer's disease. \n\nhttps://adpd.kenes.com/wp-content/uploads/sites/148/2022/03/ADPD22_-_LIST_OF_GALLERY_ABSTRACTS_FOR_WEB_January-5th.pdf\n\n\nAlso of relevance to Anavex and the MOAs of its drug candidates, both the inventor of Anavex 3-71(AF710B), Dr. Abraham Fisher, and the scientist responsible for much of its pre-clinical development, Dr. Ilya Bezprozvanny, will be giving symposium lectures at the conference. Dr. Abraham's talk will focus on activation of the M1 muscarinic receptor and Dr. Bezprozvanny's is on understanding the signaling functions of the Sigma-1 receptor: \nQuote:\nM1 MUSCARINIC STIMULATION OF POST-SYNAPTIC RECEPTORS FOR THE POTENTIAL TREATMENT AND PREVENTION OF COGNITIVE DECLINE \nhttps://cslide.ctimeetingtech.com/adpd22/attendee/confcal/show/session/30\nQuote:\nSIGMA-1 RECEPTOR - A ROLE IN NEURONAL SIGNALING AND NEURODEGENERATION \nhttps://cslide.ctimeetingtech.com/adpd22/attendee/confcal/show/session/51 -
Anavex - poster med fase 2 PDD data.
Gode data men vi skal videre med fase 3 snarest !
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Du kom mig i forkøbet der Solsen.
Meget fine data må man sige!
Dr. Jaime Kulisevsky, MD, PhD, Principal Investigator of the trial, commented, "PDD is a debilitating disorder with significant co-morbidities and there has not been a mechanistically novel medication approved for PDD in over 20 years. Hence, new therapies are urgently needed to alleviate this suffering and disability. I am impressed with the robust improvement of the MDS-UPDRS across all sub-score parts I-IV coupled with the biomarker correlated outcome measures and I support the implementation of the ANAVEX
2-73 Phase 3 studies in Parkinson's disease and Parkinson's disease dementia, respectively." -
Anavex Overbevisende data i Parkinson!!
Præsentation af yderligere analyserede resultater fra PD fase 2 forsøget på:
2022 International Conference on Alzheimer's & Parkinson's Diseases and related neurological disorders, taking place in Barcelona, Spain, and virtually on March 15-20, 2022.Anavex Life Sciences Announces Presentation of Phase 2 Clinical Biomarker Data from ANAVEX®2-73-PDD-001 Parkinson’s Disease Dementia Study at AD/PD™ 2022 International Conference
All MDS-UPDRS Part I, II, III, IV sub-scores improved, including substantial majority of individual items between 71% and 92% SIGMAR1 mRNA expression significantly increased in ANAVEX®2-73-treated patients vs placebo (p=0.035) and was significantly associated with improvements of MDS-UPDRS scores and cognitive efficacy endpoints CDR system NEW YORK, March 15, 2022 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company
Yahoo Finance (finance.yahoo.com)
All MDS-UPDRS Part I, II, III, IV sub-scores improved, including substantial majority of individual items between 71% and 92%
SIGMAR1 mRNA expression significantly increased in ANAVEX
2-73-treated patients vs placebo (p=0.035) over the course of treatment and was significantly associated with improvements of MDS-UPDRS scores and cognitive efficacy endpoints CDR system.Dr. Jaime Kulisevsky, MD, PhD, Principal Investigator of the trial, commented, "PDD is a debilitating disorder with significant co-morbidities and there has not been a mechanistically novel medication approved for PDD in over 20 years. Hence, new therapies are urgently needed to alleviate this suffering and disability. I am impressed with the robust improvement of the MDS-UPDRS across all sub-score parts I-IV coupled with the biomarker correlated outcome measures and I support the implementation of the ANAVEX
2-73 Phase 3 studies in Parkinson's disease and Parkinson's disease dementia, respectively."Stor dosisafhængig effekt og med meget lille usikkerhed p=0,035!
Patienter forbedrede endda deres motorik!!
At de også blev mindre demente med den højeste dosis på 50 mg, vidste vi jo i forvejen, men ikke at de også forbedrede deres motorik - og igen uden bivirkninger!
Nu må markedet da se at vågne op!!! -
Anavex Oversigt præsentation Parkinson
https://stocktwits.com/symbol/AVXL
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Anavex ... Eisai dropper samarbejdet med biogen på Aduhelm.
Anavex Life Sciences Corp (AVXL): From the Benzinga wire today: Biogen,...
powerwalker: From the Benzinga wire today: Biogen, Eisai Amend Their Alzheimer's Drug Marketing Pact 8:01 am, March 15, 2022 Portfolios: First Watchlist...
InvestorsHub (investorshub.advfn.com)
Det ville være en interessant partner til Anavex. Der er også nogle personrelationer, der kunne være adgang for et samarbejde.
Mener også de er med i "konsortiet"
Læser at Anavex arbejder på at give adgang til Blarcamesine for patienter flere steder - interessant hvad der kan ligge i det.
Data burde være gode nok til en godkendelse, men det plejer ikke at være nemt selv om det ville være oplagt.
10% på kursen er latterlig henset til potentialet endnu en gang er synliggjort.
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Fantastisk post fra Veliger som mest poster på Stock Twist:
Veliger
Tuesday, March 15, 2022 8:15:06 PM
Re: Bourbon_on_my_cornflakes post# 354211
Post# of 354315
I'm impatient too. In the past I've shared my analysis of what the fair value and full potential may be here...and full potential is in the hundreds per share. I want to realize it now. I also know I'd be a lot more patient today if the whole bio sector had been flat the past 3-4 months instead of down by nearly 50%, and Anavex was still in the 20's. Unfortunately, that has not panned out.I've been a holder since 2015, and I'm employed in this sector. I can tell you that at an average burn rate of $2.3M a month, while advancing multiple, late stage trials with > $10B/annual revenue potential....there's not much better in terms of time/dollar value out there. There are CEOs that take home more than the Anavex annual burn per year. Yes,, it could be faster if we partnered for peanuts or had diluted the stock to something > 100M outstanding shares. I'm not going to play Monday morning cornerback on these decision, other than to point out that Chris has in the neighborhood of 6M options, and I trust his goal is to maximize the potential here. That said, when he makes statements about shareholder value he's talking about several years...not days, weeks or months. Like you, I still want to see us move faster, buy I accept where we are and that last patient enrolled in the Alzheimer's study is just finishing up week 40 of 48 this week.
I expect we have another 6 months of waiting before the real deal....a RETT NDA filed, 48-week PDD OLE data (building off the good news today), and Alzheimer's into Sept/Oct. I honestly think the NDA being filed (our first of many) will create a very large adjustment in fair value, as it implies Pre-NDA dialogue has led to the path to file and brings legitimacy (whether FDA, UK, Canada, TGA...) which I feel is lacking today. That NDA filing could be this Summer. Obviously an approval means so much more...and that first approval anywhere will force the market to drastically recalculate the fair value, which today is off by at least 4x. GLTA.
Anavex Life Sciences Corp (AVXL): I’m impatient too. In the past I’ve shar...
Veliger: I’m impatient too. In the past I’ve shared my analysis of what the fair value and full potential may be here…and full potential is in the hundreds per...
InvestorsHub (investorshub.advfn.com)
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H.C. Wainwright Thinks Anavex Life Sciences' Stock is Going to Recover:
0 star analyst H.C. Wainwright's Ram Selvaraju reiterated a Buy rating on Anavex Life Sciences (AVXL - Research Report) today and set a price target of $42.00. The company's shares closed last Tuesday at $10.65, close to its 52-week low of $9.28.
Ja ja hellere ha en 0 stjernet positiv analyst end ingen.
Interessant at han også har et kursmaal på over 40 ligesom Veliger i min forrige post, men okay Veliger mener nu og ikke om et år.
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