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well done
do not know what is wrong...but a problem does exist..thx
14 September: Anavex reports follow-on analysis data from its Phase IIb/III study of blarcamesine in early AD On 14 September, Anavex Life Sciences Corp., a clinical-stage biopharmaceutical company developing therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer’s disease (AD), announced findings from a follow-up analysis to its Phase IIb/III study investigating blarcamesine in people with early AD. The trial was a randomised, double-blind and placebocontrolled study that enrolled 508 participants with early symptomatic AD in Australia, Canada, Germany, Netherlands and UK. Participants received blarcamesine (n = 338) or placebo (n = 170) oral capsules once daily for 48 weeks. The Alzheimer’s Disease Assessment Scale-Cognitive (ADAS-Cog) and Alzheimer’s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) subscales were used as primary end points to assess the cognitive and functional efficacy of blarcamesine. The trial was successful in meeting the co-primary endpoints. The company bolstered these clinical findings with two independent biomarkers data. The follow-up analysis demonstrated a significant reduction in pathological amyloid-ß 14 SEPTEMBER 2023 levels in plasma, as well as a significant slowing in brain volume loss, when blarcamesine was compared with placebo. When it came to safety, the most common treatment-emergent adverse event was dizziness, which was transient and mostly mild to moderate in severity. Participants who completed the trial were able to enrol in an ongoing open-label extension study, called ATTENTION-AD, where they all receive blarcamesine for about two years. The study is expected to finish next year. https://www.anavex.com/post/anavex-sphase2b3trialofblarcamesine-anavex-2-73-inpatientswithalzheimer-sdisease...duplication error...
14 September: Anavex reports follow-on analysis data from its Phase IIb/III study of blarcamesine in early AD On 14 September, Anavex Life Sciences Corp., a clinical-stage biopharmaceutical company developing therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer’s disease (AD), announced findings from a follow-up analysis to its Phase IIb/III study investigating blarcamesine in people with early AD. The trial was a randomised, double-blind and placebocontrolled study that enrolled 508 participants with early symptomatic AD in Australia, Canada, Germany, Netherlands and UK. Participants received blarcamesine (n = 338) or placebo (n = 170) oral capsules once daily for 48 weeks. The Alzheimer’s Disease Assessment Scale-Cognitive (ADAS-Cog) and Alzheimer’s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) subscales were used as primary end points to assess the cognitive and functional efficacy of blarcamesine. The trial was successful in meeting the co-primary endpoints. The company bolstered these clinical findings with two independent biomarkers data. The follow-up analysis demonstrated a significant reduction in pathological amyloid-ß 14 SEPTEMBER 2023 levels in plasma, as well as a significant slowing in brain volume loss, when blarcamesine was compared with placebo. When it came to safety, the most common treatment-emergent adverse event was dizziness, which was transient and mostly mild to moderate in severity. Participants who completed the trial were able to enrol in an ongoing open-label extension study, called ATTENTION-AD, where they all receive blarcamesine for about two years. The study is expected to finish next year. https://www.anavex.com/post/anavex-sphase2b3trialofblarcamesine-anavex-2-73-inpatientswithalzheimer-sdisease
jonj325
hnbadger1 ... agree w/this observation,
WOW...you nailed it...it is about the people who MUST be treated....
Thx J.J. , IMO Dr.M. may already be (at least partially) exploring this path. Hence .... top down delays.
Does it make more sense for AVXL top management to bundle all their CNS treatments and sell to just one (very large + Influential existing BP ) or to spread the CNS disease portfolio of solutions to various/qualified WW high rollers? IMO, it makes sense for AVXL top staff to only link w/one true BP WW organization - leader. AVXL would focus it's resources more effectively by dealing w/ one competent, credible , WW BP than to spread themselves thinner over a long period of time..
Is that decision (@ AVXL top staff level) what we are seeing? Is that why we have accumulated this CNS portfolio? Let's get real, there is no way a small leadership-technology-science staff (such as AVXL 's) could manage all the possible kinks and interfaces required to manage such a WW scope. Aren't we better off to link w/one great big WW BP and win-win-win until we cannot stand it?
Is that struggle what is REALLY going on behind to curtain?? IMO, it is a likely-realistic top management path to go down, the sooner the better.
This thought also fits w/...the best use of available AVXL leadership resources. IMO. AVXL gets to truly lead the parade and be recognized as the true source.
Are we THERE YET?
Silence is not an effective Comm. strategy.
Hope all longs are well and will prosper soon w/strong news about AVXL . This last stretch is our personal stress trial...hang in there.
test...clock 9:46
WAS GIBT?
O.K., what's going on w/bouncy AVXL SP this A.M.? Looks positive so far. We are WAAAAYYYY overdue around here for some positive-supportive developments . BTW, if this is some kind of new game...BEWARE...some of us OLD TIMERS still have a few moves left. Most of us still believe AVXL is the REAL THING and that WGT. Carry On.
hnnbadger1..Thanks for this ref. article. Some objective evidence of efficacy. finally "Our cup is (at least) half full". IMO.
[quote“These data are very exciting, particularly in a study that can demonstrate objective slowing of markers of neurodegeneration,” Michael Weiner, MD, professor of radiology and biomedical imaging, medicine, psychiatry, and neurology at the University of California, San Francisco (UCSF) and principal investigator of the Alzheimer's Disease Neuroimaging Initiative (ADNI) said in a statement.1
One of the most common treatment-emergent adverse events in the respective safety population was dizziness, which was transient and mostly mild to moderate in severity. This adverse event was reported in 120 participants (35.8%) during titration and in 76 participants (25.2%) during maintenance with blarcamesine. In comparison, this adverse effect occurred in 10 participants (6.0%) during titration and 9 (5.6%) during maintenance with placebo.
“Alzheimer disease is such a devastating disease that affects tens of millions worldwide, and Anavex’s clinical development is a testament to our determination to follow the science,” Christopher U Missling, PhD, president and chief executive officer of Anavex said in a statement.1 “We like to thank all the people involved in the study for their invaluable contributions and we look forward to advancing blarcamesine as a potential new convenient orally available treatment option for Alzheimer disease.”
REFERENCES
1. Anavex’s Phase 2b/3 Trial of Blarcamesine (ANAVEX®2-73) in Patients with Alzheimer’s Disease Shows Robust Clinical Efficacy and Slows NeurodegenerationSignificant Reduction of Amyloid Beta Biomarkers of Alzheimer’s Pathology. News Release. Anavex Life Sciences. Published September 14, 2023. Accessed September 15, 2023. https://www.anavex.com/post/anavex-sphase2b-3trialofblarcamesine-anavex-2-73-inpatientswithalzheimer-sdisease][/quote]
hnbadger1:
6.98 +0.09 (+1.31%)
After hours: -
That's little better.
Jonjones
Thanks K9uwa...lets hope today and SP actions that follow today are (at least) honest and sensible. We despise liars.
Does anyone (who knows what they are talking about) want to tell us what the AVXL SP opening price is likely to be? (ball park est. is OK. )
Have to admit that today's sp action was a mess and (IMO) was obviously some kind of set-up for who knows what?
sab63090
abew4me
Ya Know, a guy could totally lose any remaining sense of humor on a day like this.
Cannot spike fast enough or far enough for some of us...BTW, we earned many consecutive days just like this...get used to it...TIA.
AB-E-NORMAL ...well, It's a START
D-Mike...
test ...8:39 am ...pilots and crews report to your ready rooms. Prepare the flight deck for air operations.
Bioinvestor5
WolfofMia
Dr.M., I need your help w/this. Have been here for years and support your team and the process all the way, but I have limits. Would appreciate any help you can offer right now. The sooner and bigger the better. TIA.
bas2020...