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Quote “Things are developing quickly. So many catalysts coming up I’m short order. BP will not sit idle while potentially being threatened. Threatened by them or another BP jumping first.”
Agreed, I’ve always been perplexed by the inane argument of some that somehow BP has no incentive to marginalize or suppress our progress. Just look at the largest AD conference at CTAD from 2018-2020, this Company seems to be there each time with a late-breaking session illustrating significant improvements in dementia patients (especially compared to historical controls and current SOC) and little to no side effects, but rather positive ancillary QOL benefits reported.
I refuse to suspend common sense in this regard. And Cassava may be viewed similarly as Anavex to the other “interested parties”.
Time will tell. Enjoy your logical posts.
Yes abew I agree; and it actually falls in line with what I’ve theorized previously that by keeping a stranglehold on the market cap for so many years, that many retail investors (the lion’s share of the float) would eventually capitulate at the first big jump in stock price. We’d happily take 15, 20 or 25 per share to get out with a nice profit, so the theory goes.
The markets run on emotion and the MM’s and HF’s and Dark Pools at the big brokerages seemingly have the ability to compel retail shareholders to jump ship perhaps at a present value much less than a projected future value.
Not much else logically explains to me why our market cap has been so comparably low, or why so much FUD and carefully-crafted deflection has been generated online every day against the Company for 4-5 years running mostly since our initial positive AD results were p/r’d.
Just personal opinions. GLTY
Considering both avxl and sava charts today seemed to follow the same buy/sell program when viewed side by side, and that the premarket trade blocks that Xena posted this morning were consistently large; to me this didn’t seem like Joe America retail investor trading.
Lends credence IMO to the theory of coordinated accumulation planned in advance rather than random retail mania.
But CNBC wants us to believe that retail investors were largely behind the 104,000,000 shares traded today..
You want that so badly, I know.
(Just between you & me: I am NOT selling my shares.)
That is patently false on your part. Those interested in the facts can refer to the below Company slides as well as others available over the past few years.
Slides 16-17
https://www.anavex.com/wp-content/uploads/2019/03/ANAVEX2-73_CTAD_2018_Presentation.pdf
Slides 23-25
https://www.anavex.com/wp-content/uploads/2018/05/Anavex-ANAVEX2-73-CTAD-Phase-2a-November-2017.pdf
Hello Anders, I’ve personally set a VERY high sell limit order myself. I am unappreciative of the tactics employed by HF/dark pools and/or other interested parties in recent years in regard to this Company, blatantly obvious by reading regularly this board and others IMO; and I believe that they shall be forced to pay up big time if they want a stake now.
Not investment advice of course. I am simply a retail investor for the long term.
All the best to you and yours.
Very helpful PK, as usual, I’ve a position in both, but like you, I’m focused primarily on the Anavex value proposition. Clearly there’s a big money transition this week to the MOA alternatives offered by these 2 companies. GLTY
Congrats, I’m just glad I picked up 2k back when it was $5.50. Designed to be an insurance play for my Anavex position.
Should be room for both in the AD space.
Very glad to have held strong through the years here with you and the other honest, well-intentioned posters.
It appears that we may be on the verge of something big. Time till tell. Press on Nidan
Amen to that, nidan. It’s interesting that the recent Seeking Alpha article (full of errors and low key avxl shade) was pulled this week it appears.
I’m very thankful that I didn’t fall for the negative confirmation bias. It cuts both ways, you know? :)
Especially after listening to 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 associated research.
Reference time stamps 38:20 and 1 hr 15 minutes in particular pertaining to 2-73 (blarcamesine):
Steadyt I didn’t get to listen to the presentation however, there are 2 other rare disorders that were referenced in the recently issued new patent 11/30/2020: Williams Syndrome and Smith-Magenis Syndrome. See examples 6 & 7. One of these could be the yet-to-be-announced indication for another new trial in 2021:
“Example 6
Williams Syndrome--Weight Gain
[0062] A 2 year-old male presents with Williams syndrome. He exhibits a failure to thrive with low weight gain. He begins treatment with i.v. doses of A2-73 at 5 mg every other day. After 60 days of treatment, he exhibits a 10% weight gain.
Example 7
Smith-Magenis Syndrome--Sleep
[0063] A 5 year-old male presents with Smith-Magenis syndrome. He experiences disturbed sleep. He begins treatment with oral doses of A2-73 at 10 mg/day. After 15 days of treatment, his sleep is markedly less disturbed.”
https://www.anavex.com/anavex-life-sciences-announces-notice-of-allowance-for-u-s-patent-application-with-expanding-claims-covering-anavex2-73-blarcamesine-for-the-treatment-of-rett-syndrome-and-other-neurodevelopm/
https://uspto.report/patent/app/20200246303
https://www.msn.com/en-us/news/us/death-of-florida-doctor-after-receiving-covid-19-vaccine-under-investigation/ar-BB1cxiPm?li=BBnbfcL
3 weeks after Pfizer vaccine administered; not yet known whether it is connected however.
“CDC reveals at least 21 Americans have suffered life threatening allergic reactions to Pfizer's COVID vaccine - but officials beg people to get the shot and say problems are 'rare'”
https://www.dailymail.co.uk/health/article-9119029/At-21-Americans-life-threatening-anaphylaxis-receiving-Pfizers-vaccine-CDC-reveals.html
It’s the prospect of a 1 million mile battery in conjunction with fleets of Semi’s and other commercial vehicles that is partially driving growth prospects IMO.
Tesla surely has that “je ne sais quoi” quality.
https://www.google.com/amp/s/www.autoweek.com/news/amp34620676/million-mile-batteries-theyre-coming/
I’m not sure of your medical background, but I think I may defer to the experts that presented our ctad 2019 104 week conclusions from the ph2a you referred to (Mohammad Afshar, MD, PhD1; Coralie Williams, MSc1; Nanthara Sritharan, MSc1; Frédéric Parmentier, PhD1; Adrien Etcheto, MSc1; Christopher U Missling, PhD2):
“Cohort of high ANAVEX®2-73 concentration cohort shows significantly smaller decline in MMSE (-1.1) compared to ADNI AD matched cohort (-4.4) at Week 104
Cohort of low ANAVEX®2-73 concentration shows slightly smaller decline in MMSE (-3.9) compared to ADNI AD matched cohort (-4.4) at Week 104”
I believe that’s referred to as “dose dependency”. As in, I might need 400mg of ibuprofen to make my headache (from this board) subside, rather than just 10mg.
Makes logical sense to me.
Personally I’ll take a 400% improvement over placebo if I’m a newly diagnosed Alzheimer’s patient. Especially since current standard of care, donepezil, has a very similar steep MMSE decline as placebo.
Prescribe me 50mg blarcamesine and I’m staying steady and quite possibly improving and I may have less anxiety, better mood, better sleep, regain some life skills. I suspect other objective persons, might also agree.
https://www.anavex.com/wp-content/uploads/2019/12/CTAD-ANAVEX2-73-ADNI-Presentation_.pdf
Was just reviewing the comparison of safety & side effects again too. Yikes. Any chance the regulators, if not the patients and neurologists, might be able to differentiate between the 3 below options:
ANAVEX 2-73 (Blarcamesine)
“Tolerability: Maximum tolerated dose (MTD) of ANAVEX 2-73 was defined as 55mg. Observed adverse events at doses above the MTD included dizziness and headache, which were moderate in severity and reversible. These side effects are often seen with drugs that target CNS conditions, including Alzheimer's disease.”
ARICEPT (Donepezil) current SOC
More common side effects:
The more common side effects that can occur with donepezil include:
nausea
diarrhea
not sleeping well
vomiting
muscle cramps
tiredness
not wanting to eat or having a poor appetite
bruising
weight loss
Serious side effects:
Slow heart rate and fainting
Stomach ulcers and bleeding, symptoms can include:
heartburn
stomach pain that won’t go away
nausea or vomiting
blood in your vomit, or dark-colored vomit that looks like coffee grounds
bowel movements that look like black tar
Worsening of lung problems in people with asthma or other lung diseases
Seizures
Trouble urinating
ADUCANUMAB
Side effects included headache, diarrhea, and dizziness. They were mild or moderate, some possibly related to the study drug but not to the dose.
“ the higher the dose of aducanumab in the trial, the more signs of brain swelling and hemorrhaging—which show up as ARIA-E, or amyloid-related imaging abnormalities-edema.
That Phase I trial started with 165 participants, 32 of which received the higher dose. Of those, 15 developed ARIA-E, and 10 patients dropped out of the study because of adverse events, a troubling sign.”
And by the way, do you see who is discussed and followed (almost exclusively) by both RS organizations online in their posts? It’s a company you seem to really follow closely, and its VERY promising and positive results.
And who has been presenting at CTAD the last few years with trial results (presented by 3rd party experts) of AD dementia patients beating placebo by 4:1 margin, and who has AD trial participants at the therapeutic blood concentration actually IMPROVING from baseline? And has PDD patients IMPROVING from baseline in Cognitive Drug Research (CDR) memory tests in its placebo controlled trial?
I personally don’t see any other companies presenting such positive results except for our Company.
So don’t try and tell me that the large pharmaceutical companies & their associates don’t have any “interest” in whether we succeed or fail.
Let me ask you a simple question.
Do you think that Big Pharma wants to see Anavex succeed with its compound(s) and secure a large part of the CNS drug market?
YES or NO
If no, then the BILLIONS AT STAKE and COMMON SENSE tell me that there are mechanisms in the market to artificially depress and suppress a small cap biotech.
Please see previous post for just one of said examples.
The outright manipulating and depressing a stock’s price by Dark Pools is occurring in the market.
https://wallstreetonparade.com/2019/01/the-silence-on-wall-streets-dark-pools-is-deafening/ “Dark Pools function as unregulated stock exchanges inside the bowels of the largest Wall Street banks. Making the situation even more dicey, some of the big banks own more than one Dark Pool, raising the possibility that there could be cross-trading between those pools to artificially inflate or depress stock prices.”
You’re interested in what makes sense?
How about AU neurologists and dementia patients seeking a drug with a heightened SAFETY profile, better sleep, less anxiety, regaining of skills lost AND:
“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.anavex.com/anavex-life-sciences-presents-anavex2-73-blarcamesine-data-at-12th-clinical-trials-on-alzheimers-disease-ctad-2019-conference/
And the TGA has already directly emailed back, transcript was posted to this board, that any AU patient/physician can submit a request under the SAS program to seek access.
Which drug would you choose if diagnosed with dementia? Blarcamesine or donepezil, based on results published to date?
#commonsense
Aricept (Donepezil) hallucinations:
https://journals.sagepub.com/doi/abs/10.1177/026988110001400315?journalCode=jopa
Violent behavior with donepezil:
https://ajp.psychiatryonline.org/doi/pdf/10.1176/ajp.155.11.1626a
Donepezil may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
nausea
vomiting
diarrhea
loss of appetite
weight loss
frequent urination
difficulty controlling urination
muscle cramps
joint pain, swelling, or stiffness
pain
excessive tiredness
difficulty falling asleep or staying asleep
headache
dizziness
nervousness
depression
confusion
changes in behavior or mood
hallucinations (seeing things or hearing voices that do not exist)
abnormal dreams
red, scaling, itchy skin
Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:
fainting
slow heartbeat
chest pain
new or worsening breathing problems
new or worsening stomach pain or heartburn
black or tarry stools
red blood in stools
bloody vomit
vomit that looks like coffee grounds
difficulty urinating or pain when urinating
lower back pain
fever
seizures
discoloration or bruising of the skin
Donepezil may cause other side effects. Call your doctor if you have any unusual problems while you are taking this medication.
On the clinical trials site re Anavex’s PDD study, it indicates two (2) primary outcome measures.
Anavex says today that: “Both primary objectives of the study were met. The results show clinically meaningful, dose-dependent, and statistically significant improvements in the Cognitive Drug Research (CDR) computerized assessment system analysis.”
https://clinicaltrials.gov/ct2/show/NCT03774459?term=Anavex&draw=1&rank=6
“Primary Outcome Measures :
1) Cognitive Drug Research (CDR) Computerized Assessment System Continuity of Attention [ Time Frame: 14 weeks ]
Change from Baseline to End of Treatment in Continuity of Attention as measured by Cognitive Drug Research (CDR) Computerized Assessment System Continuity of Attention test
2) Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 14 weeks ]
Assess the safety and tolerability of ANAVEX2-73 compared to placebo”
And: https://www.researchgate.net/post/What-is-the-difference-between-an-end-point-and-an-outcome-measure
“..... Phase 2 placebo-controlled trial with primary objectives of safety, tolerability, and efficacy in cognition of ANAVEX®2-73 in patients in Parkinson’s disease dementia (PDD) compared to placebo. Both primary objectives of the study were met. The results show clinically meaningful, dose-dependent, and statistically significant improvements in the Cognitive Drug Research (CDR) computerized assessment system analysis.”
https://www.anavex.com/anavex-life-sciences-reports-fiscal-2020-year-end-financial-results-and-clinical-program-updates/
Same drug (blarcamesine) across multiple CNS disease indications with statistically significant IMPROVEMENTS, endpoints MET, plus safety for 5 years running.
More to come in 2021.
Conjecture alert: IF the drug were approved in the coming few months by US regulators in the RS indication, and after listening to the expert Dr Randi Jenssen Hagerman (Distinguished Professor, Department of Pediatrics, UC Davis MIND Institute, Sacramento, CA) and her excitement tonight and her want to take blarcamesine herself, and her first-hand controlled trial experiences with our drug in the Rett Syndrome indication that she outlined in great detail, and her expounding into other neurodevelopmental & neurodegenerative diseases for blarcamesine, then:
• our RPDD Voucher could seemingly be used to apply for the same drug, 2-73 blarcamesine, in another indication, per the below link
• such as Parkinson’s disease dementia, correct? (Based on our positive phase 2 controlled dementia results assumably)
• if so, then what type of pressure would then build for such a safe and seemingly quite effective medication (ref: Dr Hagerman & past comments from Dr Macfarlane as well) from other Alzheimer’s Disease and dementia patients’ families for quick access?
• would it be ethical to allow for Parkinson’s disease dementia patients (with the RPDD voucher) but not other dementia sufferers?
It appears to me that our RPDD voucher could theoretically grease the wheels of progress. And that would be a tangible blessing for other CNS disease sufferers (not a scientist).
Providing safe and effective medications for indications with serious unmet need is ultimately the GOAL based on what I’ve read.
GLTALs
See page number 18:
“ Q19. Howandwhencanavoucherbeused? 668
669 The application using the priority review voucher must be submitted under section 505(b)(1) of
670 the FD&C Act48 or section 351 of the PHS Act and is not limited to drugs for rare pediatric
671 diseases. The application using the voucher may be for a new indication of the same drug whose
672 approval led to the award of the voucher. The sponsor redeeming the voucher must notify FDA
673 of its intent to submit an application with a priority review voucher at least 90 days before
674 submission of the application and must include the date the sponsor intends to submit the
675 application (hereinafter “the intended submission date”).49
https://www.fda.gov/media/90014/download
Okay just catching some of this late, really hope someone just recorded Dr H’s comments, wow...
Your repetitive arguments fly in the face of all the information received and presented here in great detail. Enjoy your day!
Completely agree with you/Boi568/Xena on this issue. The letter of the TGA guidelines and the emailed response direct from the TGA has illustrated same.
And for those constantly arguing that because the Anavex P/R did not specifically discuss the concept of others’ ability to apply via SAS through an application via their doctor, I cannot imagine how anyone could possibly expect Anavex to actively solicit and promote and (in essence) advertise to the entire AU population in their press release.
#commonsense
+1
Yes abew4, I’m also holding my shares close to the vest, and have added yesterday and today based on our published safety & efficacy results across several indications now, two of which being controlled studies.
Everyone’s risk tolerance is different and there are no guarantees wrt the stock market of course. I’m not a scientist, past performance is no guarantee of future success, this could be a hero or a zero, etc etc..
I find interesting, however, those that believe that all market participants’ intentions & actions are as pure as the driven snow; especially when there’s BILLIONS at stake across several affected industries and huge pharmaceutical markets.
GLTY
Thankfully there are regulators, unlike yourself, who will have access to full data sets when they soon meet to discuss our “pathway”.
I’m sure the Rett Syndrome affected families are anxiously awaiting the below safety & efficacy improvements in their children and adults.
FT, ODD, RPDD designations with a voucher as well. I’ve difficulty envisioning regulators keeping blarcamesine from these families dealing with such a severe & debilitating disease (one with no current viable treatment options).
Can you imagine being told no, wait another year or two, if you were them?
Godspeed Anavex
“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”
McMag, perhaps why our low liquid formulation 5mg dosage proved as effective as it did in our RS participants?
98% absorption from liquid versus 39-53% from pill or tablet
Obviously this can vary from compound to compound, but the premise remains.
“Liquid Extracts Vs. Capsules/Tablets
The body does not need to break down a liquid extract, allowing more of the medicinal properties to be absorbed into the system. This makes an extract much more powerful than a capsule or tablet.
When using capsules or tablets, the body must first extract or break down the medicinal properties of the herb to put them in liquid form in the stomach.
Liquid extracts take 1-4 minutes to assimilate.
Capsules or tablets (pills) can take from 20-30 minutes just to break down, before the body can even start to assimilate them.
The body uses 98% of our liquid extracts.
The body only utilizes approximately 39-53% of capsules or tablets. Guess where the remainder ends up?
In order for any nutrient to reach the cells of the body, it must first be suspended in a solution. Or in other words it must be liquid. As a rule, the nearer a herbal preparation approaches the liquid form, the quicker and more completely it will assimilate and take effect in your body.”
https://medicare-europe.co.uk/science-clinical-data/liquids-vs-pills.html/
Appreciate your opinion; however mine differs from yours as it pertains to if/whether there is ample incentive or not for various interested parties to hold us back.
I explained my logic and provided a link. Difficult to prove that it is, or is not, happening.
And for the record, I called nothing a cure. I posted hypothetical and theoretical questions as it pertained to potential what/if’s.
GLTY
Opinion stated as fact. Don’t tell me what I know and believe.
I’m not selling my shares.
Right on jmvho, admittedly I’m no scientist nor a market expert, but it doesn’t take much deductive logic, IMO, to see how the BILLIONS at stake could trigger those with HUGE vested interests to take certain actions.
Very difficult to prove intent and collusion; so they either aim to shut us down or depress our price and gobble up the stock for control.
I personally see that as the MO for the past few years and why we are where we are (from a MC standpoint).
I’m sure we’ll get torched for that viewpoint, but I know what I’ve witnessed and documented for the last 4-5 years. GLTY
The large majority of current retail holders are seemingly “encouraged” and “influenced” daily to give up and sell.
And outright manipulating and depressing a stock’s price by Dark Pools in non public transactions is also occurring in the market.
https://wallstreetonparade.com/2019/01/the-silence-on-wall-streets-dark-pools-is-deafening/
“Dark Pools function as unregulated stock exchanges inside the bowels of the largest Wall Street banks. Making the situation even more dicey, some of the big banks own more than one Dark Pool, raising the possibility that there could be cross-trading between those pools to artificially inflate or depress stock prices.”
One has to ask one’s self:
a) are there any monied industries that really want to see a viable treatment for dementia patients (reversal or improvement of their condition)?
b) how about Big Pharma, would they rather Anavex succeed or fail?
c) treatment centers and nursing homes; would they like to see patients regain their functional memory and regain much of their autonomy? What would that do to their business model and massive facilities and do they have a vested interest in the status quo?
If it became evident a few years ago that this 150mm market cap biotech may very well be on to something very promising, what steps could possibly be taken to either shut them down or continue to depress their market cap in order to buy them for cheap or convince the large % of retail holders to sell in frustration?
Excellent find Tttav and comments Lima; praying for fast trials and approvals for autism spectrum disorders with blarcamesine, so as to provide therapeutic improvements to the afflicted such as Anders’ family.
The Company has been referencing their goals and intentions in this important arena in 2020.
https://www.anavex.com/anavex-life-sciences-announces-notice-of-allowance-for-u-s-patent-application-with-expanding-claims-covering-anavex2-73-blarcamesine-for-the-treatment-of-rett-syndrome-and-other-neurodevelopm/
https://rettsyndromenews.com/2020/01/10/anavex-2-73-earns-u-s-patent-for-neurodevelopmental-disorders-including-rett-syndrome/
Excellent points, Nidan, your proper perspective and focus (on what’s important) is a welcome reprieve.
Here’s to more positive results & data releases, on top of what we’ve already seen from Anavex.
“its a life changer for the entire world”
If it comes to fruition that the majority of the automakers will mostly have EV or plug in hybrids in the next few years, then it is not a bridge too far to envision future residential neighborhoods and commercial buildings be built with Tesla roof solar and built-in Tesla Power Walls for EV and home power storage.
Life changer as you said.
From 3:42pm this afternoon: https://stocktwits.com/biotek777/message/262183055
9 more trading days for traders/investors to potentially continue the run up. December to remember sales event (sorry Lexus)