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You are correct. $35 is better than $8.6.
However $350 is better than $35.
And I do expect a partnership leading up to a buyout.
A partnership alone could bring the share price closer to $100.
Approvals in Australia, UK, Europe and Canada...and the US could triple that.
The safest and most effective prevention and /or treatment for treatment for ALzheimers, PDD, Retts, Fragile X, Autism etc. could easily produce revenues over $20 billion a year. Final share price? 4 digits is entirely possible IMO!
Maybe the $3.2 billion rumour is partly correct.
How about Roche buying a 10% interest in Anavex for $3.2 billion?
That could be true.
Oh my goodness....wouldn't be terrible if we only got news on one or two of these items next week....and had to wait for a couple of weeks to get the other news around the time of the big 40 minute presentation in the middle of January!
On second thought....looking at this weeks lousy market...and a very possible January rally....could it turn out to be a very good strategy?
Oh but I forgot...there are some posters who always know what is best...and management who have brought this company to the brink of success in Alz. PD and Rett with 4 years cash on hand...know nothing!
(This is sarcasm for those who don't know.)
The new addition to the Anavex Scientific Advisory Board is very impressive! And is clearly very impressed by 2-73!
" The main focus of Prof. Dr. Grimmer’s research is assessing the usefulness of biomarkers in predicting neurocognitive disorders. He has authored numerous peer reviewed articles, amongst others the first studies that assessed the utility of amyloid PET for differential diagnosis of neurodegenerative diseases and to track Alzheimer’s disease progression. In addition, he has served as a national coordinating investigator and as a principal investigator in more than 70 drug trials including all monoclonal antibodies against cerebral amyloid load.
“I’m excited to join Anavex’s Scientific Advisory Board at this time of important growth and evolution of the Company,” said Professor Dr. Grimmer. “There is such a significant unmet medical need around the globe caused by Alzheimer’s disease and patients in the Phase 2b/3 ANAVEX®2-73-AD-004 study performed better even after a year despite the progression of this devastating disease. It would be groundbreaking for patients and their loved ones if healthcare professionals are able to provide a therapeutic which can be taken orally and is generally safe, which the study indicates, ANAVEX®2-73 (blarcamesine) is a likely candidate.”
Nice summary by John Dsouza.
"Here's what to look forward to:
===> details of the Top Line Data released two weeks ago (should be coming by month end /latest in early Jan - as its priority #1 at AVXL)
====> company has also stated that they will be meeting with federal regulators ie. FDA; Australia TGA; EMEA; UK and Pacific West for next steps to get A2-73 either approved or on an accelerated approval track
====> data on other trials in the pipeline (over the next 1-3-6 months)
====> and last but not least, we wait with bated breath on any news on partnership as the company realizes that they must partner with a big player to get name recognition but more importantly help with manufacturing; marketing and "global" sales.
Truly exciting time for AVXL and their investors!!!!
And we can expect at least half a dozen significant news items in the next weeks or next month in addition to more granular CTAD data.
! Data of 48-week OLE PDD Phase 2 study – expected by end 2022
! EXCELLENCE completion: Potentially pivotal Phase 2/3 pediatric RTT clinical trial – expected by end 2022
! Initiation of ANAVEX®2-73 imaging-focused Parkinson’s disease clinical trial – expected 2022
! Initiation of potentially pivotal ANAVEX®2-73 Phase 2/3 Fragile X clinical trial – expected 2022
! Initiation of potentially pivotal ANAVEX®2-73 Phase 2/3 clinical trial for the treatment of a new, rare disease
indication – expected 2022
! Initiation of ANAVEX®3-71 Phase 2 clinical trial for FTD, schizophrenias and Alzheimer’s disease –
expected 2022
Thanks for sharing. The conclusion makes sense to me. If it is true won't most people over 50 want to try it?
" My view has been that Anavex 2-73 is not actually an Alzheimer's drug in that it targets Alzheimer's disease. I think of it as a drug that increases overall cellular health. Some age-related diseases occur due to cellular health declining as part of the aging process. If cellular health is improved by a drug like Anavex 2-73, diseases like Alzheimer's or Parkinson's improve or perhaps in some cases go away.
What the above implies is that Anavex 2-73 is really a drug to help with all types of age related diseases and conditions where cellular health is reduced such as RETT syndrome or Fragile X. It also means that Anavex 2-73 can be given at the same time as many other drugs. This makes Anavex 2-73 a potential blockbuster of enormous potential."
And if 3-71 is even safer and more effective...it will a blockbuster on steroids!
It is good to recall Anavex's deep portfolio...and cash for four years!
" Its lead drug candidate is ANAVEX 2-73, which is in Phase III clinical trial for the treatment of Alzheimer's disease; Phase III clinical trial to treat pediatric patients with Rett syndrome; Phase II clinical trial for the treatment of Parkinson's disease; and preclinical clinical trials to treat epilepsy, infantile spasms, Fragile X syndrome, Angelman syndrome, multiple sclerosis, and tuberous sclerosis complex. The company's drug candidate also comprises ANAVEX 3-71, which is in Phase I clinical trial for the treatment of frontotemporal dementia; and preclinical clinical trials for the treatment of neurodegenerative diseases, such as Alzheimer's and Parkinson's diseases. Its preclinical drug candidates include ANAVEX 1-41, a sigma-1 receptor agonist for the treatment of depression, stroke, Parkinson's, and Alzheimer's diseases; ANAVEX 1066, a mixed sigma-1/sigma-2 ligand for the potential treatment of neuropathic and visceral pain; and ANAVEX 1037 to treat prostate and pancreatic cancer.
I had a look at BIVI. 22 person trial. Less than $22 million cash.
Do you have any other examples of "progress and professionalism"?
Apparently the market agrees with me today! However the facts have been established in very positive trial results in Alzheimer's, Parkinson's and Rett. The market is highly unstable. I suggest we can all look forward to the Jan.12 presentation. And very possibly there could be more data released between then and now! I am not worried!
It is a carefully choreographed bear raid. A handful of self declared "experts" suggest "concerns". And then they suggest that these "concerns" have some basis in reality. The fact is that Alzheimer's, Parkinson's and Rett have all had very outstanding results. As data becomes more granular, and partnerships are formed, and expedited approvals occur...these "experts" and their "concerns" will disappear!
My view is that it did not, and does not, matter what the data or Missling or McFarlane said. AF and similar shorter types planned to attack, criticize and obfuscate to make some short term monetary gains!
Honest observers acknowledge that the data is very positive in regard to efficacy and safety...and detailed analysis will reveal it is even better than the summary data.
Five things can be expected
1. More granular analysis of the data.
2. Partnerships.
3. Expedited approvals as an early treatment.
4. Larger longer term preventive studies.
5. Combination therapy trials.
Australia, U.K. and European agencies can be expected to act first...UNLESS Alzheimer care-giver groups in the U.S. can mount enough pressure for some form of expedited approval. This is not a partisan issue. Alzheimers patients cannot speak for themselves. Their care-givers must stand up and speak up for their loved ones! It has happened before!
Why do Biogen's dangerous (and expensive!) drugs keep getting approved...and celebrated in the media?Should we follow the money?
https://today.uconn.edu/2021/05/why-is-the-fda-funded-in-part-by-the-companies-it-regulates-2/#
Thanks...that makes sense. I see a whole lot of benefits with long term use!
The more you think about it, the more sense it makes to do the trials in Australia, UK, Europe and Canada. One more reason to respect Misslings judgement!
Mayo I have great respect for your detailed knowledge of the 2-73 trials. Because I consider it reasonable to expect other vital organs(heart and vascular system) beside the brain will be affected by 2-73....I was wondering if anyone had looked at its possible role in stabilizing blood pressure? I expect blood pressure readings would be taken regularly.
What will bring the share price up?
FIRST: partnerships.
Worldwide, regional or strategic local partnerships are coming. There are many BP's who will receive all available information under confidentiality agreements. I expect good partnerships as there will be competitive bidding!
SECOND: Local and regional approval of 2-73 for Alzheimers, Parkinsons , Rett and Fragile X.
Safety is well established in children and adults. Efficacy is consistently impressive.
Approvals may very well come first in Australia, Europe and Canada where the Alzheimers trials ran. Alzheimers pressure groups may need to pressure the US government for approvals. Big Pharma influence is large in the US...but partnering with a BP may change this situation rapidly. E.G. might Biogen want a share of the Anavex juggernaut?
The data is strong. Stronger in safety and efficacy than any other competitive drug! Remember that 2-73 is competing against other imperfect technologies...not against some mythical perfection!
Australian, UK, European and Canadian single payer systems should all want to reduce the enormous burden of Alzheimers and Parkinsons on their health care systems. I know the UK often rejects expensive, unsafe and ineffective drugs! Anavex did trials in potential early markets. I hope the Alzheimer lobby groups will press the US government to grant expedited approval!
The Aussie version of the FDA is very well acquainted with 2-73. In August 2020 they granted Compassionate use(SAS) status to 2-73.
Here is some background.
" Most therapeutic goods are required to undergo an evaluation for quality, safety, and efficacy, and be included on the Australian Register of Therapeutic Goods (ARTG) before they can be supplied in Australia. In recognition that there are circumstances where patients need access to therapeutic goods that are not listed on the ARTG, the TGA facilitates a Special Access Scheme (SAS) for physicians seeking to use medicines that have not yet been approved in Australia. The SAS refers to arrangements, which provide for the supply of an unapproved therapeutic good for individual patients. Applications under the SAS are made to the TGA by their treating doctor, and approval to treat the patient takes into account the safety of the drug as well as supporting evidence that the drug may benefit the patients, along with the failure of any current therapies."
IMO I would not be surprised by some sort of expedited approval in Australia
Not easier. Just fairer.
Those who subscribe to seeking alpha will find a largely positive article just came out.
"Anavex Life Sciences: The Little Company That Did"
Dec. 06, 2022 12:51 PM ET
Anavex Life Sciences Corp. (AVXL)
Lane Simonian
Summary
Anavex's 2-73/blarcamesine produced significant reductions in cognitive decline in early Alzheimer's disease as measured by ADAS-Cog and CDR-SB scores.
Those who had improvements in cognition did so by an average ADAS-Cog score of 4 points, which is considered to be clinically significant.
In an earlier phase 2a trial, most (4 out of 6) high concentration patients improved, whereas no medium concentration patients improved.
The high dose group patients in the phase 2b/3 clinical trial are likely to do considerably better than the pooled 30mg and 50mg group.
It is very difficult to gauge how the FDA will decide on blarcamesine; such a decision will be critical to Anavex's stock value.
The 2-73 trial data had to be collected from 54 trial site locations around the world. The locations are of interest.
Australia 16
Canada 11
United Kingdom 16
Germany 8
Netherlands 3
Australia represents the Asia/Pacific region.
Canada represents the North American region.
The U.K., Germany and the Netherlands represent the European region.
I would not mind if 2-73 first became available in Australia, the U.K. and Europe. Canadian approval should follow. If the Big Pharma controlled FDA is slow in its approval many Americans should be able to acquire 2-73 from Canadian sources. Many US diabetics have been securing reasonably priced insulin from Canada for decades!
The CTAD data could very well gain regulatory approval in Australia and possibly Europe. And the August 2022 CC reveals partnering discussions have been going on for at least 4 months...and probably much longer. Certainly the CTAD data will advance those discussions. Either regulatory approval or partnerships will certainly advance the share price significantly. And there is very important Rett and Parkinson data coming very soon. There are certainly many potential catalysts ... several expected before year end.
I want 2-73 for all my friends who have ALZ, and their families AND FOR MYSELF.
If they approve it first in Australia they will have one very large new export product! Good for them for supporting the trials for so many years!
See the 3Q CC August 9 2022.
" We are in discussions with European, Asian, and Chinese companies to market outside the U.S. We are also looking at global partnerships and regional partnership opportunities. We are in discussions for this already for a worldwide roll-out."
I am not worried.
1. Anavex has great data.
2. BP's know this.
3. Anavex is already discussing partnerships with BP's.
4. Approval in Australia and Europe could precede US.
5. Alzheimers groups should pressure governments. Any delay in approval is unacceptable!
ALZ is a rapidly increasing worldwide problem.
Every month of FDA delayed approval costs the shortening of millions of lives.
Contact your Congressmen, Governor and President to request rapid FDA approval of 2-73.
Literally ... peoples lives are affected with every month of delay!
God bless all those patients and their families who benefitted from 2-73.
And God bless all the scientists, doctors and investors who developed 2-73.
And may this ancient Irish blessing come true!
May those who love us, love us.
And those who don't love us,
May God turn their hearts;
And if he doesn't turn their hearts,
May He turn their ankles,
So we will know them by their limping.
Lecanemab results were touted as earth shattering!
I hope Mondays presentation will make it clear that 2-73 is twice as effective, ten times safer and 20 times less expensive!
THE PUBLIC DESERVES TO KNOW THE DRAMATIC SUPERIORITY OF 2-73!
2-73 results herald a gigantic paradigm shift.
Industry bought the Plaque hypothesis.
Universities bought the Plaque hypothesis.
Scientists bought the Plaque hypothesis.
Even the general public have only heard the Plaque hypothesis.
2-73 MOA represents an upstream activity that will affect all DNS diseases and indeed the entire body...all vital organs. All seniors suffer from diseases of aging.
2-73 has minimal side-effects and huge health gains. It is safe in children and seniors...the market potential is in the multi-billions!
Anavex has been in partnering discussion for many months! Here is what they said in the August 2022 Q3 CC.
"WE are planning on marketing Rett syndrome and possibly Fragile-X ourselves. We are in discussions with European, Asian, and Chinese companies to market outside the U.S. We are also looking at global partnerships and regional partnership opportunities. We ARE in discussions for this already for a worldwide roll-out."
Partnerships coming? You bet! And a WORLDWIDE ROLL-OUT!
Just a reminder that these great results are only from AD! This alone assures Anavex will be a 4 digit stock.
But don't forget PD, PDD, Rett, Fragile X, FTD etc. etc. HOLD ON TO YOUR SHARES. This is not the end...it is only the beginning!
2-73 results will not be compared to perfection.
THEY WILL BE COMPARED TO LECANEMAB.
I like our chances!
We should thank the organizers of CTAD.
Having Lecanemab presenting early in the Conference has set a low bar for 2-73.
Lecanemab efficacy is marginal. Its safety is questionable. The drug and infusion costs are high.
I cannot believe Dr. Mc Farlane came all the way from Australia to announce a dud!
I have to laugh at those who think Anavex would even be allowed to present Bad News in a highly coveted ORAL presentation at the CTAD Conference! And why would Anavex want to? I hope everyone has seen the recent Guggenheim presentation. The slide about Catalysts to Drive Value (15) speaks of a "potentially pivotal Phase 2b/3 AD clinical trial" reporting. Even double blinded trials can reveal obvious benefits to researchers! Looking forward to Dec. 1 and have added bargain shares.
Let us assume that Lecanemab and 2-73 are equally efficacious.
And let us assume that patients and care givers are equally happy to spend several hours every two weeks getting a Lecanemab infusion as spending several seconds every day taking a 2-73 pill.
And let us assume that the very serious safety concerns about Lecanemab don't matter.
We are left with a very important difference in COST.
Lecanemab is a monoclonal antibody and therefore very expensive to produce.
And it must be delivered every two weeks via infusion. Infusion takes time and infusion centers are usually very overburdened with Covid and cancer patients...and an added COST.
2-73 is very inexpensive to produce and taking a daily pill adds no cost.
Might it be fair to suggest that 2-73 treatment could cost about 1/10 the cost of Lecanemab treatment?
Who cares? Both patients and health care systems!
It will be interesting to compare ANAVEX 2-73 to Biogens drug. IF THE BENEFITS ARE EQUAL there are significant safety concerns about lecanemab. Two patients have died in their trial from apparent drug related causes. And an infusion every two weeks is a lot costlier and disruptive than taking a 273 pill once a day! That why ANAVEX has a huge safety, cost and delivery advantage.
The recent Guggenheim presentation is worth a look.
https://guggenheim.metameetings.net/events/neuroimmunology22/sessions/43319-anavex-life-sciences-corp/webcast?gpu_only=true&kiosk=true
Mink SITC 2022 posters are full of very exciting data! Here are some highlights.
1.Allogeneic unmodified iNKTs (agenT-797) show reductions in target and non-target lesions or disease stabilization in patients with solid
tumor cancers when administered alone [27%] and in combination with pembrolizumab (KEYTRUDA®) or nivolumab (OPDIVO®) [66%].
Phase 1 data show early signals of activity with disease stabilization in patients refractory to standard of care and those
who have progressed on KEYTRUDA or OPDIVO.
agenT-797 preferentially kills tumor-promoting M2 macrophages while preserving pro-inflammatory M1 macrophages
associated with anti-tumor responses.
agenT-797 can be dosed up to 1000x106
cells without lymphodepletion showing no signs of neurotoxicity and cytokine release syndrome (CRS grade ≥ 3).
2.Allo-iNKTs show signals of durable disease stabilization and modulation of M-spike protein seen in heavily pre-treated r/r multiple myeloma patients (2/8) after ≥6 prior lines of therapy.
3. agenT-797 shows 70% survival in severe viral ARDS compared to site reference controls (~10%); potential for a variant agnostic approach
to infections. In Phase 1/2 study, agenT-797 shows survival of 70% in mechanically ventilated patients compared to ~10% in a comparative case control population.
4. Increased 90-day survival in a subgroup of patients on respiratory bypass (ECMO) of 75% compared to 30% in a
comparative cohort with median survival of 119.5 vs 47 days.
agenT-797 demonstrates a favorable safety profile. Only 1 grade ≥3 treatment related adverse event and no CRS was
observed. agenT-797 treatment was associated with a reduction in secondary infections, including reduced incidence of pneumonia at
the highest dose level, a driver of ICU mortality.
5. MiNK’s FAP-CAR-iNKT therapeutic candidate, MiNK-215, demonstrates robust efficacy in non small cell lung cancer (NSCLC) preclinical
models, promoting curative responses, eliminating tumor burden in the lungs, and enhancing tumor specific CD8+ T cell infiltration
through tumor stroma.
FAP-CAR-iNKT demonstrates a drastic increase of CD8+ T cells infiltrating the tumor and significantly increased tumor
killing compared to T cells in murine models.
MiNK-215 shows robust preclinical efficacy towards tumor expressing FAP (FAP+ cancer model), underscoring potential to
target FAP+ tumors.
6. MiNK-413 is a differentiated allogeneic IL-15-armored-BCMA-CAR-iNKT therapeutic candidate, a next generation approach designed to
overcome the limitations of current autologous cell therapies.
MiNK-413 demonstrates superior tumor clearance in a systemic multiple myeloma models, compared to control BCMA-CAR.
Armoring MiNK-413 with soluble IL-15 enables prolonged persistence, which may translate to increased durability in patients.
MiNK-413 has the potential to target a broader population of patients with multiple myeloma.
7. MiNK’s proprietary CARDIS platform enables high-throughput rapid selection and optimization of functional CARs, like
MiNK-413 (IL-15-armored-BCMA-CAR-iNKT) and MiNK-215 (FAP-CAR-iNKT).
Allo-iNKTs (agenT-797) reinvigorate partially exhausted T cells and improve effector functions within the tumor microenvironment; critical
mechanisms in rescuing PD-1 refractory tumors.
In addition to their direct anti-tumor activity, allogeneic iNKT cells (agenT-797) improve immune effector function of immune
cells in the tumor microenvironment.
agenT-797 restores the cytotoxic capacity, activation, and cytokine production of partially exhausted T cells. agenT-797 preferentially kills tumor-promoting M2 macrophages while preserving pro-inflammatory M1 macrophages associated with anti-tumor responses.
agenT-797 activates dendritic cells, which can promote activation of T cells through enhanced antigen presentation.
The full poster presentations can be accessed on the publication section of MiNK’s website at https://minktherapeutics.com/publications/.
ARDS data will be important. BARDA support is a big deal.
Very interesting company. I like it's chances.