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Forum Anavex Life Sciences Corp geopend

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  1. Lingus 17 juni 2021 13:07

    • Lingus

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    quote:

    BigMoepf schreef op 17 juni 2021 08:51:

    Volatiele dagen voor Anavex (en Cassava). Ik mik persoonlijk voor beiden op een market cap van 5 miljard om (tijdelijk) uit te stappen. Volgens mij liggen die waardes 'om de hoek'. Lees: voor Anavex bij succesvolle p2 readouts en bij Sava bij de nieuwe ruimere datasets in juli.
    GLTA!
    Ik ben het ongeveer eens met je. Ik hou mij AVXL voorlopig vast, zeker zolang de marketcap van Anavex lager is dan die van Cassava. Zou andersom moeten zijn. Mijn positie in Cassava heb ik daarom 20% afgeroomd. Ik verwacht dat beleggers, geholpen door analisten, toch langzaamaan hun posities Cassava wat gaan afbouwen ten gunste van Anavex.
  4. Wallander 21 juni 2021 09:14

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    quote:

    holenbeer schreef op 21 juni 2021 07:19:

    @Lingus, zit jij ook in Synaptogenix? Kan natuurlijk teruglezen maar je schrijft behoorlijk veel :-)
    Stukje op SA gelezen over Synaptogenix?
  9. Lingus 21 juni 2021 13:21

    • Lingus

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    Als ik het goed begrijp probeert Synaptogenix hetzelfde met Bryostatin-1 waar Neurotrope in 2017 nog faalde. Zie ook: www.fiercebiotech.com/biotech/neurotr...
    Veel clinical trials te vinden met het moeilijk te synthetiseren Bryostatin-1 maar alles fase 1 of 2. Veel geluk als je aandelen SNPX hebt, maar ik stap hier niet in.
  10. G.dezwaluw 21 juni 2021 13:33

    • G.dezwaluw

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    Anavex Life Sciences Announces ANAVEX®2-73 (Blarcamesine) Biomarker Correlated with Efficacy Endpoints in Placebo-Controlled U.S. Phase 2 Clinical Trial for the Treatment of Adult Patients with Rett Syndrome

    ANAVEX®2-73 treatment resulted in significant increase in the expression of the SIGMAR1 mRNA biomarker that significantly correlated with improvements in the two primary clinical efficacy endpoints RSBQ (p = 0.035) and CGI-I (p = 0.029)

    Data strengthens milestone to advance regulatory approval pathway for adult patients with Rett syndrome and continued development in other autism spectrum disorders

  12. BigMoepf 21 juni 2021 14:54

    • BigMoepf

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    Wederom mooi. Het wordt hier tijd voor een beduidend hogere market cap in mijn ogen.

    Ik ken Rett Syndrome niet goed genoeg, maar zou een significante verbetering hier ook voor een BTD kunnen zorgen? Of is die markt al deftig bedeeld of zijn die resultaten niet goed genoeg om van een breakthrough te spreken?
  13. forum rang 4 harvester 21 juni 2021 17:16

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    quote:

    BigMoepf schreef op 21 juni 2021 14:54:

    Wederom mooi. Het wordt hier tijd voor een beduidend hogere market cap in mijn ogen.

    Ik ken Rett Syndrome niet goed genoeg, maar zou een significante verbetering hier ook voor een BTD kunnen zorgen? Of is die markt al deftig bedeeld of zijn die resultaten niet goed genoeg om van een breakthrough te spreken?
    Als het voor RETT werkt is de kans groter IMHO dat het ook voor.andere CNS ziektes positief werkt
  15. holenbeer 21 juni 2021 23:43

    • holenbeer

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    quote:

    Wallander schreef op 21 juni 2021 09:14:

    [...]

    Stukje op SA gelezen over Synaptogenix?
    Nee, nog niet. Heb al wel een tijdje een kleine positie, beetje spreiden in de AD-hoek.
    Zal eens lezen.
  16. holenbeer 21 juni 2021 23:47

    • holenbeer

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    quote:

    Lingus schreef op 21 juni 2021 13:21:

    Als ik het goed begrijp probeert Synaptogenix hetzelfde met Bryostatin-1 waar Neurotrope in 2017 nog faalde. Zie ook: www.fiercebiotech.com/biotech/neurotr...
    Veel clinical trials te vinden met het moeilijk te synthetiseren Bryostatin-1 maar alles fase 1 of 2. Veel geluk als je aandelen SNPX hebt, maar ik stap hier niet in.
    Dank! Heb er een paar, leuk winstje. Als ze een sympathiestijging met AVXL of SAVA doen, gooi ik ze er wellicht uit.

    Edit: net dat SA artikel gelezen, er zijn na 2017 nog wel wat voortschrijdende inzichten. Ik hou ze nog even voor een gokje, met 50 mio market cap is er niet veel downside.
  17. Phill 22 juni 2021 11:47

    • Phill

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    Mooie analyse van Rett resultaten:

    Graphs posted onderaan press release:
    www.anavex.com/anavex-life-sciences-a...

    Anavex 2-73-RS-001 Adult Low Dose Rett Trial (U.S.)

    To precede commentary on Anavex 2-73-RS-001 data, I want to bring investor attention to a particular portion of the 21 June 2021 Rett press release. “This study demonstrates for the first-time that a biomarker correlates with clinical efficacy in Rett Syndrome”. This claim underscores the importance of Anavex and their precision medicine approach and is crucial in evaluating the data provided to investors today. Most of the data provided was specific to the Sigma-1 receptor (S1R) wild type (WT) gene and how those patients responded to treatment vs. placebo.

    Uninformed investors will claim that Anavex cherry-picks their data, that the company is not being fully transparent, or complain that Blarcamesine does not work equally for all patients. In reality, Anavex is using a pre-specified biomarker (found in over 80% of the population) to prove that patients with that biomarker respond to treatment. The only data that will matter to the FDA for ultimate approval is data involving S1R WT patients. The fact that non-WT patients still respond (just less) is a bonus. Bottomline: the company is not trying to prove that everyone responds equally, nor do they need everyone to respond equally.

    Slide Deck
    Phase 2: Improvement in All Key Domains

    This is the only slide to show the entire patient population (25 patients in phase 2, 15 dosed, 10 placebo). We see that all key endpoints were met with statistical significance by week 7, which includes RSBQ, CGI-I, and ADAMS. RSBQ is a 45-point assessment which includes general mood, motor impairment facets, and sleep, amongst other behaviors. CGI-I is a review of the patient by a clinician in which the clinician assesses whether they think their patient has improved relative to a baseline state (a state prior to drug trial). And finally, ADAMS measures anxiety, mood, and depression, amongst other facets. Interestingly, CGI-I is only seen in this slide, with data suggesting clinicians overwhelmingly believed dosed patients holistically improved. Anavex may have excluded a deeper look of this data on account of it being the least objective of the three measures listed.

    ADAMS Total Score

    This chart shows clinically meaningful and statistically significant improvement (p=0.005) at week 7 for the ADAMS assessment. Week 7 saw a 12.9-point improvement between dosed (-10.10 point) and placebo (2.75 point), with negative scores representing improvement and positive representing worsening. As a note, the term ‘clinically meaningful’ is the absolute gold standard for drug approval. A clinically meaningful drug meets a certain established threshold which indicates the drug will have a genuine positive effect on daily life.

    ADAMS Subscale Score

    This chart shows balanced improvements across all subscales. The subscales include Manic/Hyperactive Behavior, Depressed Mood, Social Avoidance, General Anxiety, and Obsessive-Compulsive Behavior. The Cohen’s d effect size is 1.31, which implies a massive effect. A massive effect such as this means that most dosed patients saw improvements on the highest end of measurement, above the mean. While all the ADAMS data was impressive, three of the measures were particularly interesting. Obsessive compulsive disorders had a whopping 64% difference between dosed and placebo, which was the highest difference of any ADAMS measure. Secondly was general anxiety, with a 46% measure. Differentiation between dosed and placebo score for general anxiety leads me to believe this is a ‘true score’, a benefit that is likely indisputably due to the drug. Lastly, depression had a 40% difference between dosed patients and placebo. Once again, there was a substantial differentiation between placebo and dosed, which I would consider to be a true score. Social avoidance and manic/hyperactivity had dosed/placebo differences of 30% and 28% respectively. The ADAMS data seems to confirm the Anavex 2a AD trial data which saw markedly lower depression and better mood in those patients.

    Rett Syndrome Behavior Questionnaire (RSBQ) Total Score

    This chart shows clinically meaningful and statistically significant improvement at week 4 (p=0.006) and week 7 (p=0.009) for RSBQ. Week 7 saw a 14.5-point improvement between dosed (-8.92 point) and placebo (5.56 point), with negative scores representing improvement and positive representing worsening. It is interesting that RSBQ was able to garner statistical significance at week 4 as well as week 7, opposed to ADAMS which saw statistically significant at week 7 only. This does seem logical to some degree based on emotional and mental response to natural healing. If one’s body begins to heal it may take some time after until their emotional disposition responds to their repair. This is only conjecture and there could be several logical reasons for ADAMS taking additional time to reach statistical significance. In any case, 7 weeks is not a long trial, and it would be interesting to see the OLE data at some point.

    RSBQ Subscale Scores

    This chart shows balanced improvements across all subscales by end of week 7. The subscales include General Mood, Breathing Problems, Hand Behaviors, Repetitive Face Movements, Body Rocking and Expressionless Face, Night-time Behavior, Fear/Anxiety, and Walking/Standing. Once again there are some subscales that proved to be exceptionally interesting. First being the night-time behaviors subscale, which saw a massive 61% difference between dosed and placebo patients. Differentiation between dosed and placebo score heavily indicate this being a true score. Nighttime behaviors were also noted to be dramatically improved in the Anavex 2a AD trial. The next subscale of interest is general mood with a large 43% general mood, followed by body rocking and expressionless face at 41%, repetitive face movements at 38%, and breathing problems at 32%. Breathing problems are one of the more significant problems when it comes to Rett safety concerns, so it is very promising to see such an effect in that category. To finish the subscales, fear/anxiety saw a 24% difference, walking and standing at 12%, and hand behaviors at 11%. I believe walking and standing as well as hand behaviors saw smaller effects due to the age of participants. These patients have gone many, many years with impaired motor skills. To be able to reverse these symptoms dramatically in a short 7-week period seems unrealistic. It is likely the pediatric group would see greater effect here due to their age and stage of development.

    Summary

    The Anavex 2-73-RS-001 data is overwhelmingly positive with broad therapeutic effect noted with statistical significance and clinical meaning in all primary endpoints. Anavex continues to impress upon investors the importance of precision medicine and the role of S1R as a diverse healing agent. Many of the subscale facets and impressive safety data synergized with Anavex 2a AD and PDD trial data.

    Considering the adult cohort and low dose of this trial, the Anavex 2-73-RS-002 and RS-003 data will likely command even greater therapeutic effect with younger patients and higher dosing. It is my opinion that Anavex will receive accelerated approval from regulators for Rett syndrome.
  20. Missolapola 22 juni 2021 13:57

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    quote:

    G.dezwaluw schreef op 22 juni 2021 13:52:

    Dan zijn we er direct vanaf. Volgende week kunnen we veel hoger staan
    Hoort er inderdaad gewoon bij. Voor wie nog wil instappen: het is het moment.
  21. forum rang 6 mercurius-adept 22 juni 2021 16:04

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    quote:

    Wallander schreef op 22 juni 2021 13:49:

    Anavex haalt 50 miljoen op. Dat zal een tijdelijke terugslag geven.

    www.anavex.com/anavex-life-sciences-a...
    "Issuance and sale of an aggregate of 2,380,953 shares of its common stock at a purchase price of $21.00 per share to Deep Track Capital"

    www.deeptrackcapital.com/team
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