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Jon....sorry to take bit of opposition to the "small potatoes" characterization of our operations....several large clinical trials in deadly diseases, several more trials in various stages with orphan diseases and these clinical actions taking place in numerous countries and national health agencies. All with a very small staff! So internally someone has been put in charge of the company's operation. No doubt we will find out in a week!
Our competition is having an uphill grind with the medical community!
https://www.fiercepharma.com/marketing/leqembi-launch-hamstrung-physicians-therapeutic-nihilism
Jon....you are on the right track with the discussion of a "partnership" at least for Alzheimer's. That has been voiced strongly by Missling in the past. I think it was approached with Biogen over 2-73's early indication for MS, but the competition of 2-73 and aducanumab in Alzheimer's destroyed the two company's cooperation at the time (MS is still on the board for 2-73). I would venture that an MMA will be followed or proceeded by a partnership with someone like Merck. Merck's success with Keytruda, now being used in 16 cancer applications, would give it impetus to partner with a company who has two drugs that have multiple applications in neuroscience!
Gary...your positive logic is right on. Anavex trials have proved 2-73 has efficacy against deadly and debilitating diseases and it is very safe! In the meantime, due to the length of the prolific trials and their bureaucracy...people die as a result of those diseases. The very goal of being very safe in the development of drugs can take a very dear toll. The example of the development of COVID vaccines was...."time is of the essence". The FDA, EMA and other national health agencies need to accelerate cures while they insure product safety!
Tred...you are absolutely correct. We are looking at market mechanics/manipulation were the market wants constant news. And when a Biotech has numerous successful trials, two excellent products, many patients/families wanting to continue to use of those products and a healthy bank account....it can't be the fundamentals! SAVA and ANVS are up in the market with no better fundamentals. Science and stock analysis can lead to no other conclusion other than forces who want a continued short position or cheap shares before EMA/FDA positive news. Sad commentary on the development of effective drugs that have the potential to positively help millions who never sought their plight.
Steady....we postulate a bit on manipulation and are scoffed at by many posters....but how many days are like today when there a significant build up in the pps only to have it manipulated toward the close where somebody(s) buys a couple of 100,000 shares at the lowest price of the day. No news and the market is generally up.
Maybe someone who has been on the market floor could explain this manipulation of a sound stock with so much potential. I know the almost 20 million shares held by shorts where the lower the pps the more to be made....but that's not what makes America "great"!
Talon
Bill....you are so right about Leqembi(and you spelled it right). It is certainly not been the blockbuster that Biogen/Eisai had anticipated. The plaque crowd has been letdown by the FDA and EMA. As I have pointed out in earlier posts, Biogen and Anavex have been going around since aducanumab and 2-73 went at each other(for Alzheimer's) in Anavex's MS evaluation in Biogen's lab years ago!
Talon
Biogen is holding below $200 ($194) despite Lequembi. They and their big institutional investor, BlackRock, are using their MM/Shorts to keep AVXL at bay. Those who say there is no manipulation have not counted the "dollars" in the WW Alzheimers market!
Hope we are looking at AI for phama use!
https://www.biospace.com/article/patented-ai-platform-identifies-promising-early-stage-biopharma-assets-and-companies/?utm_campaign=Newsletter%20%7C%20GenePool&utm_medium=email&_hsenc=p2ANqtz--4AAruhwPECtjqAI_MMfIbz3Hhi57zvDhxJ1ufo_zNbU4F2JkVu0j1dG1bFu68iOWhMtiIxPJRQzefd1wFEiw2J18dsQ&_hsmi=303089958&utm_content=303089958&utm_source=hs_email
Mkc....BlackRock has continued to increase its shares of AVXL, but as I have pointed out, it has a lot more shares of BIIB, Lilly and others in the Alzheimer's race. It's covering all the bases and has maneuvered our price downward. Mark my word, when we apply with the EMA and are accepted, it will pounce. If we don't partner soon, we maybe the target of a "hostile takeover".
Talon
Tred....thanks for your positive logic as the markets give the current companies in the Alzheimer's realm a hard time....SAVA -2.62$(11%), ANVS -.66$(5.6%), BIIB _1.48$(.75%).....we are only down.09$(2%) but bumping against the bottom! But, no place to go but up^^^^^^^^., so look up!
Talon
Nidan...unfortunately many of science's most important advances have faced market reluctance due to competing entities already accepted. I think that is no more evident than in pharmaceuticals where the wait tine for development and approval is such a long labored time. I think that those drugs which are accepted do all that they can to inhibit any new technology both from market techniques to buy-out. The biotechs, where the majority of innovation is, live with that every day. It's tough being their cheerleaders!
Plex ....have faith for a bit longer for all those millions of people with Alzheimer's, Parkinson's, Schizophrenia, Retts, Fragile X and many more in the future. They have faced long years of hope and we do too. There is a brighter future for those who don't have any other option other than to wait for our drugs to be approved!
The hours are long before dawn.
Talon
Xena.....I think we are closer in thought than my simple one line comment. Our chief institutional owner is BlackRock which the article identifies as one of the AI's biggest culprit. I bet they have a higher percentage of our stock when the next quarter is reported. They have no desire for Anavex to compete with Biogen/Eisai and Lilly who they presently have significant more invested in. Yet they are hedging their bets with Anavex. The trouble is timing with little Anavex having many trials with such a little staff and much of the drug development being done "offshore" and under multiple national medical agencys'rules. That is the cause for our company's laboring and the readily apparent need for a large/capable "partner". Once that marriage is made, things will move much faster. Let's pray that is soon!
"Informed AI speculators can collude and achieve supra-competitive profits by strategically manipulating excessively low order flows, even in the absence of agreement or communication that would constitute an antitrust infringement."
With 1.2 million traded per day. someone is picking up cheap shares every day!
You are correct Xena, and the acceptance in Europe, which has a huge Alzheimer's market, will cast a positive endorsement for the other counties' medical agencies!
Investor...if we could only get Scott back to carry the mail for Anavex and 2-73/3-71 in the attack on neurodegenerative diseases. But, I believe we will soon get some deep thinkers at the EMA and FDA who will champion what our drugs accomplish thru the Sigma1 approach. It is always "darkest just before the dawn".
Talon
Trader....we stand on the shoulders of our fathers' bravery and sacrifice!
Steve......welcome in April to the senior Anavex group. My father flew B-24's over Ploiesti in 1944 and I flew B-52's over Vietnam in the late 60's. You and I with other older investors need Anavex to be successful in a more timely fashion!
Todays news in the field of Alzheimer's drugs. Anavex will join the press when the EMA give the go ahead!
https://www.investors.com/news/technology/alzheimers-disease-treatments-eli-lilly-donanemab-amyloid-beta/?src=A00220
Tred.....I stand with you. It's how capitalism works when we share thru our investment the development of companies and there products. Although, it is a bit discouraging when the mechanics of the markets favor material gain over invention, especially when a company is developing products which meet the well being of society. These are the rapids of a free flowing stream of commerce which has benefited the world like no other. I particularly wish our heath agencies like the FDA, EMA etc were more aggressive in enabling the flow of beneficial medicine and not bowing to pharmaceutical politics and an overly protective perspective. The wait for the long development of effective drugs results in the degradation and death of thousands, if not millions.
Enough philosophy for this morning.
Talon
Biogen/Eisai having a little EMA scrutiny over lecanemab and an update on the latest blood test for Alzheimer's. You'll have to go to Yahoo for the article on the blood test.
https://finance.yahoo.com/news/1-eu-drug-regulator-does-110543039.html
Meds....the high participation in "compassionate use" and ( 91/94 %) in the OLE is the indication that the Rett Community wants Anavex to continue efforts for 2-73 approval. The Rett organizations in the U.S., AUS, and UK have ben positive about 2-73.
https://rettsyndromenews.com/news/phase-2-extension-trial-shows-sustained-benefits-anavex-2-73/
https://www.facebook.com/rettaustralia/videos/as-most-would-know-australia-led-the-world-charge-of-the-anavex2-73-rett-study-h/371369912047422/
https://www.facebook.com/rettaustralia/videos/as-most-would-know-australia-led-the-world-charge-of-the-anavex2-73-rett-study-h/904845874628635/
Plex....would believe that Anavex is preparing the Alzheimer's data with both the EMA and FDA requirements as as objective goals. One of the reasons for the EMA at the head of the sequence of submittal is probably the plan for achieving the monetary benefit of accelerated approval with Rett. Whether that will come is now questionable. The peer review is of course out of Anavex's hands, but will be beneficial to both submissions. One will build on the other and there will be a an accelerative factor in dealing with both Agencies. With the Rett OLE data, I believe that submission will proceed with Rett families encouragement.
When you review all the trial and submission activity with Alzheimer's, Rett, Parkinson's, Schizophrenia, Fragile X, the medical and financial world is wondering how such a small biotech is able to handle it all. Someone will have to find another equivalent size biotech with the same scope. Drug development is extremely hard and laborious....maybe some of the naysayers on the board could come up with numerous examples of similar sized biotechs with the same scope of drug development and facing the same level of challenges!
Plex...with the good news in Alzheimer's, Parkinson's and Rett(Adult, OLE) plus the upcoming new trials in Fragile X, Schizophrenia, etc, it has to be market manipulation in order for the big guys to acquire cheap shares. The continual climb of institutional shares proves that! There is no bad news..maybe biotech mechanics....and those who stick with Anavex will reap the reward in this year and the thru the future.
Sab....I'm praying for you and hope you mend soon.
Talon
Good research George.....a high level of skepticism of the amyloid plaque approach from medical experts at my alma mater!
There are enough negative torpedoes on this board to sink a fleet! Meanwhile from the MJFF we read about their research with Anavex 2-73. Be patient and positive!
From the MJFF:
Tracking Drug that Improves Cognition: Anavex Life Sciences is testing a drug with the potential to slow or stop Parkinson’s. ANAVEX2-73 activates the sigma-1 receptor protein, which protects brain cells from harmful stress and toxic protein buildup. After ANAVEX2-73 showed improvement on thinking and memory in people with Parkinson’s disease dementia, the company is studying how the drug works in the brain through imaging scans and blood tests. This can help guide future trials. We previously funded Anavex for laboratory studies toward development of ANAVEX2-73.
Baked....in the short time on the board you have been quick with your "opinion" while Falconer has provided years of reasoned scientific background on Anavex's drugs and he is speaking from a science background. I usually don't critique others posts, but my suggestion is to stick to the science and the market's reasoned/unreasoned response and not personal critiques like this one.
Plex... there is little interest by the "street" in pre-sales biotechs and this IMO makes them vulnerable to market manipulation. Look at our large short contingent which wants to keep the sp low. Then there is big Pharma that doesn't want the competition or wants to buy their development stage drugs at bargain price. Then there is the huge heath care industry that wants care instead of cure. And on top of that is the current government administration which is touting reducing drug prices with little thought about what it has taken in time and money to bring a drug to the market. What we need is "Combat Medicine" which is totally focused on saving the patient!!
Its obvious that "Alzforum" is riding the "big guys" coat tails as its reporting of the Lisbon Conference was almost solely about the "amyloid plaque" products of Biogen, Eisai, Lilly and others, Not a mention of any of the other drug approaches of which Dr Grimmer had a very optimistic report on 2-73. Even Aducanumab was mentioned after Biogen has withdrawn it from commercialization. The big reporting was about improvement in amyloid plaque AIRA in these drugs. How the FDA has failed the Alzheimer's patient world with its narrow approach to this disease! Its been 3 to 4 years since the NIH started its Alzheimer campaign with little to show for it, but its fixation on amyloid plaque and tau!
From the Conference:
Data from these programs have convinced many researchers that anti-amyloid antibodies will hold a key role in treating AD. “Immunotherapies will be widely used,” Barker of the DDF predicted, adding, “We’re already thinking about how to position new drugs in combination with them.” At the same time, some people will not be able to take these drugs, due to having high vascular amyloid or other contraindications. “Amyloid immunotherapy is not for every patient,” Scheltens cautioned.—Madolyn Bowman Rogers"
Plex....its beyond me. From those very savvy in market mechanics should come a possible answer soon..but, not yet. As precursor of an advance or decline from an insider is possible. It is obvious move from an entity with its hands on 4.3 million shares who has purchased them below the low $5's. Although, the trade did not indicate the buyer, that should become known soon also. From the comments on the board, it shouldn't be because of pending law suits. A comment on that....while it appears we have a number of "jailhouse lawyers", lets concentrate on the fact that we have a couple of drug candidates which have the distinct possibility of helping "millions" who need it now or in the future! I watched a commercial on Merck's Keytruda last evening where the company highlighted the drug's successful use in "16" different cancers and possible application or combination applications in many more. I have reason to believe because of medical research that 2-73/3-71 will be compared with "Keytuda" in the field of neurology in years to come. We can debate Anavex's management skills as a young Biotech, but mark my words, there are more than a few Pharmas who are aware of its proven science.
Anavex's volume was not in line with companies that have Alzheimer's drugs.....SAVA 605 T, ANVS 119 T, BIIB 2.4M/Eisai 116 T, Lilly 3.7 M.
Schwab says you can believe whatever you want about a significant volume move!
https://www.schwab.com/learn/story/trading-volume-as-market-indicator
Lilly's Donanemab faces a more difficult and delayed approval process as the FDA looks at its efficacy and side effects such as brain swelling. That coupled with a slower market uptake of Biogen/Eisai's Leqembi gives 2-73 a bit more development time in the Alzheimer's market.
https://www.investors.com/news/technology/eli-lilly-stock-buy-now/?src=A00220
Quiet period comes during negotiations with a partner. It will be necessary to have production, advertising, sales and European delivery plans at a proficient stage prior to 2-73's EMA approval. I have read where biotechs have been behind demand of their newly approved products and it has been detrimental especially in a very anticipatory and competitive market. A BPharma partner can help when the approving agency sees that the drug will timely get to a needy patient world!
Pog....thanks for your english lesson, but other than your personal definition of evasive using a pejorative example of Anavex's CEO, a dictionary example in this instance is: "Some make the virus more evasive when faced with antibodies and other immune system cells." In other words...some make the "mabs" effectiveness more evasive without further testing.
Biogen, Eisai and Lilly and their high cost and possibly dangerous drugs to attack symptoms rather than causes show that Anavex and other companies still have a future in the quest for Alzheimer's treatment!
Eisai is pushing Leqembi in Japan and putting money ito the new blood tests to tell of amyloid plaque before the Alzheimer's symptoms are visible. Treatment is over $20,500 a year and requires evasive tests now. Its efficacy is only 27% over placebo. That there may be second thoughts about the "mab" treatmeants and their side effects is evident in the FDA additional requirements for Lilly's drug. It appears that the bar is low at the FDA and Anavex may ready to submit a NDA application as the MMA process proceeds with the EMA.
https://asia.nikkei.com/Business/Pharmaceuticals/Eisai-Biogen-Alzheimer-s-therapy-to-cost-about-20-000-per-year-in-Japan
Alzheimer's future sales forecast....that is shortly in our future starting in Europe!
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Despite Leqembi's launch pains, Eisai projects Alzheimer's med will reach $8.8B in the long run
By Fraiser Kansteiner
By Eisai’s 2026 fiscal year—which ends in March 2027—the company figures its Alzheimer's disease drug Leqembi can bring home 290 billion Japanese yen (nearly $2 billion) in global revenues. Come fiscal year 2032, those sales could potentially swell to a whopping 1.3 trillion yen ($8.8 billion). In the near term, the company is dealing with some launch hurdles.