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Yes. Getting blamed for spreading a disease I don’t have to people who are vaccinated. That’s a first.
?
Interestingly one of the last sites online that you could watch Dr Pierre Kory’s December 2020 sworn Senate testimony regarding iverm…tin (and the “miraculous” healing benefits and ability to stop this pandemic quickly and safely and inexpensively using this off patent and readily available medication that has been dosed over 4 billion times over 40 years) has now been censored from Vimeo.
Already had been removed and suppressed by YouTube and others incredulously and unethically.
I have serious concerns about the motives of “leadership” and their partners in the big pharma and MSM.
God save us all.
Indeed thank you and Dr Rand Paul spoke this week on this very issue. He as well seemingly cannot understand how the Scientific Leaders are banning and censoring and suppressing open discussion of the scientific studies and reports in recent weeks indicating the superior and robust immune system antibodies after infection/exposure as well as killer T cells and Memory B cells in recovered patients (natural immunity) that have been found by SCIENTISTS to be long term (possibly for decades) per Cleveland Clinic and Washington University School of Medicine and the new 8 month (simply the length of the study, not the ultimate term of antibodies) of the longitudinal study released at the end of July 2021.
It’s time for some common sense and for stakeholders to cut this mandatory injection and coercion/shaming. They are not being scientific, instead it appears largely political and seriously misguided at this point.
“It’s just a mask." "It's just six feet." "It's just two weeks." "It's just non essential businesses." "It's just non essential workers." "It's just a bar." "It's just a restaurant." "It's just to keep from overwhelming the hospitals." "It's just to make the cases go down." "It's just to flatten the curve." "It's just a few inmates." "It's just to keep others from getting scared." "It's just for a few more weeks." "It's just church. You could still pray." "It's just a bracelet." "It's just an app." "It's just for tracing." "It's just to let others know you're safe to be around." "It's just to let others know who you've been in contact with." "It's just a few more months." "It's just a large gathering but for protests." "It's just a few violent protests." "It's just a vaccine." "It's just a little microchip." "It's just a blood test." "It's just a scan." "It's just for medical information." "It's just a vaccination certificate." "It's just like a credit card." "It's just a few places that don't take cash." "It's just so you can travel." "It's just so you can get your driver's license." "It's just so you can vote." "It's just a few more years.” It’s just the NEW WORLD ORDER.
Lawsuit (preliminary injunction) today by America’s Frontline Doctors calling for an end to the administration of these mRNA gene therapy injections, and it is a VERY interesting brief. 1st 42 pages are a must read for anyone that was considering these mRNA injections for themselves or particularly for their kids
https://americasfrontlinedoctors.org/legal/tro/
Watch for the world’s biggest Freudian slip https://t.co/VXFeL7JjPa
— Alex Berenson (@AlexBerenson) July 17, 2021
That’s a cop out. I’ve had flu vaccines and my family has all other conventional vaccines and I am not anti vax.
As I said before and you maybe missed/ignored, I fully acknowledge the need for a covid vaccine and welcome any high risk group to, by all means, utilize personal choice to take these emergency use authorization mRNA injections after consultation with their physician, as their risk/reward profile makes sense.
You undoubtedly understand the concept of risk/benefit and informed consent and how that applies to the young and developing aged cohort and the inanity of the current media/administration/big tech narrative to entice and coerce and force them to take a not yet approved gene therapy injection which not one person on this planet knows the long term safety effects of.
And I don’t need your shares, trust me that’s not what this is about. Thanks for the disingenuous offer nonetheless.
Taas, I appreciate your well meaning sentiment, however you do realize that anyone that chooses to allow the currently available vaccines into their deltoid can certainly choose to do so at this time at their volition and control as they see fit based on their risk profile and after discussions with their own physicians? No one is stopping them.
The number of fatalities that you speak of were undoubtedly all in the high risk cohorts and they should’ve known that they were high risk and taken personal responsibility for their own well being, without being hand-held or coerced or influenced by the Government.
Do not however extrapolate that my children and other developing young adults should be forced or enticed or de facto mandated (to step foot on college campuses this Fall) to receive in their arms this emergency use authorization gene therapy injection that is not yet long term safety tested and cannot and is not yet declared Safe by the FDA (per their own guidelines).
Good luck to you.
Thanks for the link; published online March 15, 2021 and unfortunately well before the vaccine bio distribution study was released under FOI request and before the many reported adverse events were starting to be reported & summarized from the UK yellow book system and the FDA’s own VAERS system.
I fully acknowledge the need for a covid vaccine and welcome any high risk group to, by all means, utilize personal choice to take these emergency use authorization mRNA injections after consultation with their physician, as their risk/reward profile makes sense.
But I wholly and vehemently disagree with the pressuring and coercing and de facto mandating (for entering college campuses) extremely low-inherent-covid-risk children and teens and developing young people from the possible and UNKNOWN long term effects on their bodies of this experimental gene therapy vaccine injection.
The mRNA packages and spike proteins are seemingly entering the blood stream and aggregating (for how long and what are the short term and long term effects?) in various organs and systems of the body according to the Japanese bio distribution Pfizer report released to the public last month; and likely explains the wide ranging list of adverse events in the millions of reported cases per VAERS/yellow book/EMA reporting.
Informed consent is an integral component of bio-ethics and that is shamelessly and negligently being glossed over in this current situation.
We should all have free will and personal choice in our own medical decisions and the government should stay the hell out of it.
I find it “interesting” how the MSM has essentially white-washed the recent black-box warning for the mRNA vaccine in a group of children. Try to google the topic. Hardly a mention across big tech and media outlets.
Best to bury it I suppose so as to not conflict with the official narrative, correct?
And by all means let’s not expect any serious (public) discussion of the WHY in terms of all the varied mRNA covid vaccine side effects.. (yellow card system in UK and VAERS system in US etc)
There is a WHY. But dare not dig that far, right?!
(When we change the innate immune system to manufacture the spike proteins in our own body (mRNA gene therapy injection), and then all of those cytotoxic spikes circulate in our blood stream, does it really take a proverbial rocket scientist to figure out there’s a strong possibility of diverse ADVERSE EVENTS in various areas of the body?)
Thrilled for the Parkinson’s Disease community, in particular the patients, who should be availed of blarcamesine immediately.
Controlled trial. Stat sig. Dose dependent IMPROVEMENTS from baseline. Serious unmet need. Improved sleep. Safe. No SAE’s. Oral administration. Improvements in PD motor skills/movements, and in PD dementia.
Now I understand why the Doctors that had ACTUALLY reviewed our data, Drs Jaime Kulisevsky Bojarski, MD, PhD and Dag Aarsland, MD, were “extremely encouraged” in their previous PDD blarcamesine 2-73 comments.
“Principal investigator Jaime Kulisevsky Bojarski, MD, PhD, professor of neurology, and vice-dean, faculty of medicine, Autonomous University of Barcelona, and director of the movement disorders unit, department of neurology, Sant Pau Hospital, said in a statement, "As the first double-blind trial of ANAVEX 2-73 (blarcamesine) in PDD, this proof-of-concept study provides extremely encouraging data. PDD can be debilitating with significant co-morbidities. New therapies are urgently needed to alleviate this suffering and disability.””
And
“”Given the limited options of adequate treatments for Parkinson’s disease dementia, and the safety concerns and modest or uncertain efficacy of currently used off-label treatments, the ANAVEX 2-73 (blarcamesine) study results represent a meaningful step forward toward urgently needed treatment for this serious complication of Parkinson’s disease,” Dag Aarsland, MD, PhD, professor, and head, department of old age psychiatry, Institute of Psychiatry, Psychology & Neurosciences, King’s College London, said in a statement.”
Excellent point, infitvest, and furthermore, if you were the parent of a Rett Syndrome-afflicted child, tell me you wouldn’t be effectively knocking down the door of your child’s neurologist’s office and/or the RS advocacy organizations to (essentially) demand immediate access to blarcamesine after reading yesterday’s results and slides and charts from our placebo controlled trial.
Wild horses could not keep me away.
No treatment currently available. Serious and debilitating rare disease of unmet need.
It’s time to provide these patients with our safe and very effective compound, and at an early enough age to slow/reverse the course of the disease.
Godspeed Anavex.
Quote:
“Data suggests that activation of SIGMAR1 results in the restoration of complete housekeeping function within the body ...”
Doesn’t get much better than that. At only 5mg low dose and across the board stat-sig positive efficacy for all endpoints & no serious AE’s.
It’s (beyond) time to make blarcamesine available for CNS disease sufferers.
Congrats to the patients & their families, and to the Anavex team, especially Dr Kaufmann who has dedicated his career to genetic diseases, with a particular emphasis in Rett Syndrome.
Another article this afternoon re our AD “competition”, adu(no one’s at the)helm: https://www.cnn.com/2021/06/17/opinions/biogen-alzheimers-drug-opinion-ramachandra-ross/index.html
“Normally, FDA approval of a drug means that the agency has done its due diligence in reviewing data from pivotal clinical trials, confirming that the drug has proven benefits that outweigh any known or potential risks. This approval, however, was unlike any other in memory. Biogen, the pharmaceutical company behind aducanumab, conducted two clinical trials, both of which were halted in March 2019 after an independent data monitoring committee concluded that the drug was unlikely to benefit patients.”
“.... After reviewing the data, 10 of the 11 members voted that these data did not offer convincing evidence that the drug was effective (the 11th was uncertain). It is highly unusual for the FDA to go against such a clear recommendation from experts it convened for advice. But the story takes another turn.
After the committee voted, the FDA changed the rules in the middle of the game. Instead of using the cognitive scale that was the focus of both clinical trials to determine patient benefit, the FDA decided to use a different endpoint: MRI findings of brain beta amyloid, a protein thought to reflect Alzheimer's disease.”
#triggered
Today’s below article on aduscam further illustrates the disaster this decision is/was, and how in-the-tank for big pharma that the regulators (at least) appear to be.
In all reality, it wouldn’t take more than 45 minutes for govt leaders and drug agencies to read articles such as the below, along with a cursory review Anavex’s recent presentations and trial results and this week’s independent peer reviewed publication confirming Anavex’s AD/CNS disease MOA, and then employ some COMMON SENSE and BASIC CRITICAL THINKING about which road to travel down in order to solve this massive unmet need for dementia-afflicted patients.
If the FDA and government leaders truly view AD as a war that must be won, and quickly, then how the #%!! are they not taking the 45 minutes to review such material?
Is there a war on dementia related diseases or not? If yes, then how weak is leadership that they cannot lift their heads to read the writing on the wall? Or if they have read it, why aren’t we seeing them approve a more effective ammo (safer and efficacious compound(s)) such as blarcamesine?
Anavex has been front & center with their positive results and lack of adverse events, and their positive 2-73 blarcamesine ancillary effects and oral pill administration and dose dependent Improvements in dementia patients for several YEARS at recent AAIC and CTAD conferences with Late Breaking and Developing Topics, so no one can argue that they don’t know about our results to date, and know of the key divergences between Aduscam and blarcamesine.
The general public cannot be kept in the dark on this situation much longer. Alzheimer’s Association, where are you on these key divergences? Have you any common sense and/or interest in better safety and efficacy and ease of administration for your constituency??
“For days, critics have blasted the approval in opinion columns and tweets, saying there is insufficient evidence of efficacy and expressing skepticism about whether getting rid of amyloid clumps improves brain function. They argue the drug — with a list price of $56,000 a year per patient — offers false hope while threatening Medicare’s financial health and patients’ pocketbooks. Three members of an FDA advisory board that recommended against approval of the drug have quit.
Public Citizen, a watchdog group that frequently criticizes the FDA, on Wednesday called for three top FDA officials to resign, saying the approval was “reckless.”“
https://www.washingtonpost.com/health/2021/06/17/alzheimers-drug-controversy/
Amen to that, Bud and Powerwalker, falconer has been way out in front on this, and I’ve certainly appreciated his good faith explanations of our MOA and therapeutic potential.
God willing he’ll be able to be prescribed blarcamesine in due course for his rare condition as well.
Thoroughly enjoyed the peer review today. And thanks nidan for your and talon38’s and many others’ common sense and value added analysis over the years; honest due diligence & deductive logic seem to have prevailed over the egg-throwing spectators from the sidelines.
Godspeed Dr M and the Anavex Management Team
Excellent vids, enjoyed those; and this is a great printable 2 pager protocol also from Eastern Virginia Medical School.
Good luck to you, appreciate the quality posts
https://www.evms.edu/media/evms_public/departments/internal_medicine/Marik-Covid-Protocol-Summary.pdf
And these DO Med schools have the right approach as well:
https://imcwc.com/html5-blank/evms-covid-19-management-protocol/
“The bottom line is to start supplements and Ivermectin early, at the first sign of Covid19 infection.
Symptomatic patients at home (for the duration of acute symptoms)
• Vitamin C 500 mg and Quercetin 250–500 mg 2x/day
• Zinc 75–100 mg/day (elemental zinc)
• Melatonin 10 mg at night (the optimal dose is unknown)
• Vitamin D3 2000–4000 IU/day.
• Highly recommended Prescription: Ivermectin 0.15–0.2 mg/kg orally (repeat on day 3). Adults, 3mg tab, 4 tabs on day 1 and repeat on day 3.
• Aspirin 81–325 mg/day (unless contraindicated). ASA has antiinflammatory, antithrombotic, and
antiviral effects. Platelet activation may play a major role in propagating the
prothrombotic state associated with COVID-19.
• B complex vitamins
• Optional: Famotidine 40 mg BID (reduce dose in patients with renal dysfunction) [82-88].
• Optional: Omega-3 fatty acid – 4 gram/day EPA/DHA. Omega-3 fatty acids have anti-inflammatory properties and play
an important role in the resolution of inflammation. In addition, omega-3 fatty acids may have
antiviral properties.
• In symptomatic patients, monitoring with home pulse oximetry is recommended (due to
asymptomatic hypoxia). The limitations of home pulse oximeters should be recognized, and
validated devices are preferred. Multiple readings should be taken over the course of the
day, and a downward trend should be regarded as ominous. Baseline or ambulatory
desaturation < 94% should prompt hospital admission.”
Minnie here’s an excellent ivermectin video to see before it’s deemed inconsistent with the acceptable narrative:
For your reading and comprehension, below is from the peer reviewed publication released last week which runs completely counter to your erroneous and disingenuous claims:
The Neuropharmacology publication noted that in the clinical study, 57 weeks of oral once daily ANAVEX®2-73 treatment showed patients improved cognition scores by +2.0 points on MMSE, a 9% mean improvement from baseline to 57 weeks, corresponding to a calculated ADAS-Cog score change of -3.4 (improvement). In these same patients ANAVEX®2-73 also improved ADCS-ADL, by +4.9 points, a 7% mean improvement from baseline to 57 weeks.
An extension of the published study (ANAVEX2-73-003) demonstrated that for the same patients at week 70 MMSE scores improved by +3.0, a 14% improvement from baseline, corresponding to a calculated ADAS-Cog score change of -5.1 (improvement). In these same patients, ANAVEX®2-73 also improved ADCS-ADL, by +6.0 points, an 8% mean improvement from baseline to 70 weeks. The mean MMSE and ADCS-ADL baseline scores for these patients in this study were 22.3 and 71.1, respectively.[4],[5]
This data seems to be consistent with the effect of ANAVEX®2-73 on cognition assessed in the recently completed placebo-controlled Phase 2 study of 132 patients with Parkinson’s disease dementia (ANAVEX2-73-PDD-001) with once-daily administration of oral 30 mg ANAVEX®2-73, 50 mg ANAVEX®2-73 and placebo for 14 weeks. The observed statistically significant improvement of CDR system Episodic Memory of +42.22 between 50 mg ANAVEX®2-73 and placebo was also dose-dependent (p = 0.003).[6] CDR system Episodic Memory has been shown to be highly correlated (70%) with the ADAS-Cog score (r = 0.7).[7]
The calculated corresponding ADAS-Cog mean change from baseline score is -1.9 (improvement) for patients in the 50 mg dose group, an 8% mean improvement from baseline to 14 weeks. The difference between the ANAVEX®2-73 group and the placebo group in the change from baseline at 14 weeks was a 4.0-point improvement of calculated corresponding ADAS-Cog score (p = 0.015).
The Mini-Mental State Exam (MMSE) and the ADAS-Cog (Alzheimer’s Disease Assessment Scale–Cognitive Subscale) are standard tests for assessing changes in cognition in Alzheimer’s disease trials and known to correlate to a high degree.[8] The ADCS-ADL (Alzheimer’s Disease Cooperative Study–Activities of Daily Living), assesses the competence of patients with Alzheimer’s disease in basic and instrumental function or activities of daily living.“
https://www.anavex.com/anavex-life-sciences-reports-anavex2-73-blarcamesine-featured-as-a-disease-modifying-small-molecule-in-phase-3-clinical-trials-in-a-new-publication-in-medical-journal-titled-future-av/
What’s up bas, just checking in here occasionally, but AF used to post on ihub as O...P as you know, and T_Wills over on Stocktwits.
Press on
Well said and after reading tonight the new press release regarding our AD peer review, I’m left wondering when/why/what will it take for patients’ advocates to learn just how positive this is, and to demand immediate access for their afflicted patient or loved one.
The peer reviewed publication should resonate loudly going forward.
Boston great post, and I started buying in with the initial 5 wk results in Fall 2015. It’s been quite a ride, and likely there’s little chance I’d have had the confidence to hold all these years without all of the excellent DD and authentic posters to this board.
Press on sir, and cheers to the incredibly positive news today and the patients that will hopefully be given the chance by regulators to benefit from same.
Very interesting, thank you for posting that article from today
New trial posted on clinical trials.gov today:
https://clinicaltrials.gov/ct2/show/NCT04784897?term=brilacidin&draw=2&rank=2
Yes saw that article today too on CNBC site, interesting that we were one of only 5 companies mentioned.
Timing is curious. Just a couple weeks after what appeared to be a huge accumulation of our stock (117 million shares traded).
“Top Wall Street analysts say buy stocks like Denny's and Cloudflare”
Sent from the CNBC app. Available on the App Store
It is indeed an inconvenient truth for those trying to protect us from ourselves.
Nanny State gone wild.
Great points biostock and also it appears, based on the p/r, that independent researchers (University of California San Diego) identified the underlying cause of Alzheimer’s disease (changes in the structure of chromatin) and then the November 2020 paper cited below finds that the S1R (our compound’s direct target), when activated, works to restore chromatin structures.
Oh, and our “ANAVEX®2-73 compound is linked to the prevention and treatment of age-associated diseases through induction of the autophagy “cellular recycling” process and enhanced protein clearance in cells.”
That type of p/r would likely be a multi-billion addition to a BP’s market cap, in my opinion naturally.
GLTY
[Couly et al., Knocking Out Sigma-1 Receptors Reveals Diverse Health Problems. Cell Mol Neurobiol (2020); Lee et al., Sigma-1 receptor chaperones rescue nucleocytoplasmic transport deficit seen in cellular and Drosophila ALS/FTD models. Nat Commun. 2020 Nov 4;11(1):5580.]
New Anavex job posting today
https://www.indeed.com/m/viewjob?jk=8be5b1edf42d0766&from=serp&prevUrl=https%3A%2F%2Fwww.indeed.com%2Fm%2Fjobs%3FsameL%3D1%26q%3DAnavex%26l%3D%26from%3DsearchOnSerp
Clinical Research Scientist 5+yrs REQ in Pharma or Clinical Drug Dev.
Anavex Life Sciences
Remote•Temporarily remote
Job details
Salary
Up to $140,000 a year
Job Type
Full-time
Temporarily remote (COVID-19)
Qualifications
Bachelor's (Required)
Clinical Trials: 7 years (Required)
Clinical Research or Clinical Scientist: 5 years (Required)
Full Job Description
Clinical Research Scientist – Job Description
Overview:
The Clinical Research Scientist (CRS) position serves a key role within the Clinical Development R&D team, reporting to the Head of Clinical Research Science/Chief Medical Officer. The CRS works closely with the assigned study team(s) and medical director(s) to support the activities associated with one or more clinical studies. This position collaborates
with clinical team members as well as with functions outside of clinical to provide high quality and timely deliverables. The CRS is responsible for achievement of personal goals which support study team, project team, and corporate goals.
Responsibilities:
Lead or support assigned study level activities for 1 or more clinical studies with minimal supervision; may lead or co-lead a study.
Thorough understanding of assigned protocol and protocol requirements.
Support study start-up/conduct/close-out activities as applicable.
Preparation, storage, maintenance of clinical documents.
Protocol development process with minimal guidance; including writing, reviewing, adjudication/resolution of cross functional comments, and ensuring high quality final document).
Performance of medical monitoring duties, under the supervision of medical director(s), depending on the qualifications and experience of the candidate. Should be appropriately trained and fully aware of all aspects of the drug under investigation and the requirements of the protocol, including any annexes and amendments. In order to function as a medical monitor, the candidate should have adequate medical, pharmaceutical, and/or scientific qualifications, and clinical trial experience.
Draft and review of Protocols, Informed Consent Forms (ICF), and related documents; review/support finalization of regional and site ICFs as needed; ensure high quality, appropriate reading level text, and alignment with protocol).
Draft, review, and coordination of Regulatory Documents (e.g., IB, Briefing Books, DSUR, regulatory responses).
Draft, review and validation of clinical study reports; thorough understanding the connection between the data and the clinical study report.
Plan site and CRA training; including logistics, materials and presentations.
Support country/site selection activities.
Collaboration with Clinical Operations for budget preparation, CRO scope of work, etc. (i.e., review and provide feedback on activities/instructions/deliverables related to study data, IVRS, central labs, patient reported outcomes).
Study committee (e.g., DMC) activities such as charters, meetings, presentation preparation.
Investigator Meeting and SIV planning/facilitation/presentation.
Activities related to data generation and validation, including CRF creation, clinical data review, communication as needed to resolve data queries, draft/update/review data review plans, support medical director(s) in data and analyses review (generation of reports, action plans, trend identification).
May support clinical development planning (assist with analysis of data and review of literature to support future planning).
Collaborate with study team members (Clinical/Medical, Clinical Operations, Data Management, Statistics, Drug Safety, IMSC, Regulatory Affairs, Translational Medicine and Project Management) to ensure that key milestones are met on time and with high quality.
Provide guidance and scientific expertise within team, across department, and across functions.
Lead the planning and preparations for external/stakeholder meetings (e.g., IMs).
Present data/information to external investigators or study staff (e.g., SIV presentations).
Identify and liaise with external partners.
Identify, escalate current/active/future issues; propose and enact solutions.
Education Requirements:
Bachelor’s degree with 7+ years; or PhD/MD/PharmD with 2 years relevant career experience.
Degree in the Life Sciences or significant experience in clinical development ( > 11 years).
5+ years of experience in clinical science, clinical research, or equivalent.
Proficient knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations.
Proficient knowledge and skills to support program specific data review, trend identification, data interpretation.
Knowledge of medical, scientific and clinical research techniques in CNS therapeutic area.
Required Experience and Skills:
Pharmaceutical and/or clinical drug development experience.
Excellent oral (including presentation) and written communication, computer/ database management and project management skills.
Preferred Experience and Skills:
Neuroscience experience, preferably in neurodegenerative or neurodevelopmental disorders.
Ability to effectively communicate and collaborate across functions and job levels.
Ability to assimilate technical information quickly.
Routinely takes initiative.
Detail-oriented.
Strong sense of teamwork; ability to lead team activities.
Proficient in Medical Terminology and medical writing skills.
Proficient knowledge of the disease area(s), KOLs, indication(s), compound(s) under study (including MOA, PK/PD, biomarker & safety profile).
Nailed it biostockclub. Thanks for sharing your thoughts on recent events
Dr Randi Hagerman’s 1/12/21 lecture series topic had a noticeable spotlight on 2-73:
“The need for treatments that improve mitochondrial function, such as Anavex 2-73 can make a difference for both neurodevelopmental disorders and neurodegenerative disorders including Rett syndrome, FXS, Parkinson Disease, Alzheimer Disease and FXTAS. Future new treatments for FXSD will be reviewed including genetic interventions.”
https://health.ucdavis.edu/mindinstitute/videos/images/dls/hagerman-2021-dls.pdf
And she and her colleague, Dr David Hessl from the UC Davis Mind Institute, will again speak on 3/3/21 at the Fragile-X Patient-Focused Drug Development Meeting
https://fragilex.org/wp-content/uploads/2021-03-03-NFXF-PFDD-Agenda.pdf
Reassuring to have yet another world renowned and respected CNS disease researcher supporting our 2-73 compound in ADDITIONAL difficult to treat conditions & diseases of unmet need.
I’ll take the actual positive and consistent trial and real world results (just a sample of which excerpted below) over pompous self-righteousness and negative bias on your part, every day of the week.
https://www.anavex.com/proof-of-concept-controlled-phase-2-clinical-trial-data-evaluating-anavex2-73-blarcamesine-in-parkinsons-disease-dementia-presented-at-ctad-2020-conference/
Statistically significant improvements in CDR system Cognitive Domain of Attention assessed by Choice Reaction Time (p = 0.039) and Digital Vigilance (p = 0.008)
Statistically significant dose-dependent improvements in Episodic Memory (p = 0.003)
ANAVEX®2-73 (blarcamesine) prevented the on-going cognitive decline in treated patients compared to placebo
Late breaking abstract of cognitive outcome measures relevant to Alzheimer’s disease selected for oral presentation at CTAD
https://www.globenewswire.com/news-release/2019/12/04/1956062/0/en/Anavex-Life-Sciences-Presents-ANAVEX-2-73-blarcamesine-Data-at-12th-Clinical-Trials-on-Alzheimer-s-Disease-CTAD-2019-Conference.html
“Propensity score matching (PSM) was applied using Linear Mixed Effects (LME) models including descriptors of age, sex, SIGMAR1 p.Q2P carrier status, APOE4 allele and MMSE at baseline to select patients with similar baseline characteristics and any confounding factors between AD patients in the Phase 2a ANAVEX®2-73 (blarcamesine) cohort and AD patients from the ADNI control cohort.
Change in MMSE score from baseline at week 104 of matched cohorts was assessed. It showed that ANAVEX®2-73 (blarcamesine) high dose cohort had a significantly lower MMSE decline (-1.1) compared to the ADNI control cohort (-4.4) at week 104 (p < 0.01).“
https://www.arianapharma.com/2018/10/arianas-ai-demonstrate-clinical-efficacy-of-anavex2-73-for-alzheimers-patient-ctad-2018/
Using Ariana’s proprietary KEM® (Knowledge Extraction and Management) advanced Artificial Intelligence technology, the analysis of the longitudinal 3-year(148-week) data showed that patient cohort with the higher concentration of ANAVEX®2-73 maintains Activities of Daily Living Score (ADCS-ADL) and display a reduced cognitive decline (MMSE) when compared to the lower concentration cohort.
https://www.anavex.com/anavex-life-sciences-announces-anavex2-73-blarcamesine-meets-primary-and-secondary-endpoints-in-placebo-controlled-u-s-phase-2-clinical-trial-for-the-treatment-of-adult-patients-with-rett-syn/
Anavex Life Sciences Announces ANAVEX®2-73 (Blarcamesine) Meets Primary and Secondary Endpoints in Placebo-Controlled U.S. Phase 2 Clinical Trial for the Treatment of Adult Patients with Rett Syndrome
Primary safety, pharmacokinetics and secondary efficacy endpoints met, with consistent improvements in RSBQ Total scores and CGI-I
Efficacy endpoints demonstrated statistically significant and clinically meaningful reductions in Rett syndrome symptoms and correlated with changes in biomarker (glutamate) of disease pathology
Key milestone met to advance regulatory approval pathway for adult patients with Rett syndrome
UC Davis Rett Trial Comments:
Bonus footage for you of the 1st hand accounts of and comments yesterday from the research doctor from UC Davis that has dedicated her career to these CNS patients and Rett Syndrome patients and associated research. Reference time stamps 38:20 and 1 hr 15 minutes in particular pertaining to 2-73 (blarcamesine):
RedShoulder, in that same discussion: did the Company envision this type of POSSIBLE stealth accumulation of shares by a competitor, IF that’s what has been occurring in recent years and into last week?
Of course many of us remember the separate glossy mail out from management that arrived by mail before the annual meeting in March 2019 stressing the importance of voting yes to pass the 10,000,000 blank check preferred shares (anti takeover measure) by amending the Company’s articles of incorporation to allow for the approval of said preferred shares; according to Anavex thereby “discouraging, delaying or preventing an undervalued change in control of the Company”.
Interesting to me, that’s all.
I’m invested here for over 5 years, haven’t sold a single share yet, and have been accumulating at a reasonable rate. The other part of your post is also laughably incorrect. That’s all I’ll say about that at this time.
Some carefully-crafted doubt inserted there, and thanks for the humor this afternoon. That is so logical to think that our US based company, situated in NYC, with their sights clearly set on AD approval both in the USA and likely worldwide, with a 24 year FDA veteran on staff, would deliberately design a potentially pivotal ph2/3 Alzheimer’s trial with 450 participants that would need to be run yet again as a ph3 with US sites in order to achieve US approval.
That’s pretty rich, “doc”.
https://www.arianapharma.com/2018/10/arianas-ai-demonstrate-clinical-efficacy-of-anavex2-73-for-alzheimers-patient-ctad-2018/
Dr Afshar may disagree with your biased negativity. After 148 weeks for the therapeutic high-dose participants they maintained (on average) their baseline readings (some improved and some declined); but overall a significant improvement over current standard of care’s expected declines.
By all means, please read the above announcement; same was presented at Ctad. Do we expect that a low dose is going to produce those types of results, or a therapeutic high dose? Pain subsides with 10mg of ibuprofen or 600mg?
Seems common sense to me; dose-dependent cognitive improvement is what the outside experts and the company are telling us.
Pick your chart line if you’re a recently diagnosed AD patient: you’re going with standard of care decline or high therapeutic dose of 2-73?
YMMV, I’m not a scientist, all can do their own reading and DD.