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I share the same nagging curiosity about zero leaks based on potentially world changing results. The trial NDA the participants and/or their families had to sign must be a humdinger.
The all out pursuit of clearing amyloid plaques to treat ALZ has not slowed in spite of multiple setbacks. News from yesterdays Eli Lilly earnings call.
August 5 - Biopharma Dive Publication
"The Food and Drug Administration has agreed to an expedited review of Eli Lilly’s experimental Alzheimer’s disease medicine donanemab, the pharmaceutical company said Thursday."
"The agency’s acceptance of Lilly’s application starts a six month clock, setting up a potential decision from the regulator by early February. Lilly had not previously disclosed completion of the application, which it began submitting last fall but slowed after Medicare finalized a restrictive coverage policy for Alzheimer’s drugs like Lilly’s."
"Donanemab is one of several drugs in late-stage clinical testing that are aimed at a protein called amyloid beta, which accumulates in sticky plaques in the brain. Targeting this protein has been the dominant approach toward treating Alzheimer’s for decades, but has yielded a long list of failed drugs and unsuccessful studies."
"Last summer, Biogen won a controversial FDA approval for its amyloid-targeting drug Aduhelm, despite contradictory clinical trial evidence it worked. Rather than rule directly on the drug’s impact on cognitive decline in patients with Alzheimer’s, the FDA granted an accelerated approval based on its ability to reduce amyloid levels."
The FDA has learned nothing and forgotten nothing.
Wonder if shorts will be spewing a river of fear, uncertainty and doubt today? Odds are good.
When you call the Anavex Corporate offices tomorrow...
Identify yourself as C-Level executive from XYZ Pharma who is calling on behalf of your CEO. You'd like to setup a meeting, as soon as it can be arranged, to discuss the possibility of a distribution partnership.
If your pockets are extraordinarily deep, you'd like to include some, what would it take, acquisition scenarios in the talks just for fun.
Assume you're not the only caller.
I expect a fair number of people on this board hold positions in AVXL and SAVA. Hopefully both will make a meaningful contribution to solving the ALZ puzzle.
July 21, 2022 - Sidebar within the Science article suggesting falsification of ALZ research data and images. Cassava appears to have a serious PR problem.
"Research backing experimental Alzheimer’s drug was first target of suspicion"
BY CHARLES PILLER
"When Vanderbilt University physician and neuroscientist Matthew Schrag first grew suspicious of work underlying a major theory of Alzheimer’s disease (see main story, above), he was following a different trail. In August 2021, he provided analysis for a petition to the Food and Drug Administration (FDA), requesting that it pause two phase 3 clinical trials of Cassava Sciences’s Alzheimer’s drug Simufilam. The petition claimed some science behind the drug might be fraudulent, and the more than 1800 planned trial participants might see no benefits.
That month, Schrag submitted stinging reports to the National Institutes of Health (NIH) about 34 published papers by Cassava-linked scientists, describing “serious concerns of research misconduct.” His findings, including possibly manipulated scientific images and suspect numerical data, challenge work supported by tens of millions of dollars in NIH funds. Some of the studies suggest Simufilam reinstates the shape and function of the protein filamin A, which Cassava claims causes Alzheimer’s dementia when misfolded. (Other publications have reported on the FDA petition, but not Schrag’s identity. The Wall Street Journal has reported that the U.S. Securities and Exchange Commission is also investigating Cassava.)
In February, FDA refused to pause the trials, calling the petition the wrong way to intervene, but said it might eventually take action. Independent image analysts and Alzheimer’s experts who reviewed Schrag’s findings at Science’s request generally agree with him.
Schrag’s sleuthing implicates work by Cassava Senior Vice President Lindsay Burns, Hoau-Yan Wang of the City University of New York (CUNY), and Harvard University neurologist Steven Arnold. Wang and Arnold have advised Cassava, and Wang collaborated with the company for 15 years.
None agreed to answer questions from Science. Cassava CEO Remi Barbier also declined to answer questions or to name the company’s current scientific advisers. He said in an email that Schrag’s dossier is “generally consistent with prior allegations about our science … such allegations are false.” Cassava hired investigators to review its work, provided “nearly 100,000 pages of documents to an alphabet soup of outside investigative agencies,” and asked CUNY to investigate, he added. That effort “has yielded an important finding to date: there is no evidence of research misconduct.” (CUNY says it takes allegations of misconduct seriously, but otherwise declined to comment because of its ongoing investigation.)
Last year, Schrag reached out to most of the journals that published questioned papers. Seven were retracted—including five by PLOS ONE in April. Three others received expressions of concern; in each case, the editors said they were awaiting completion of the CUNY investigation. In a few cases, the editors told him, reviews were underway.
Cassava has said editors of two suspect papers dismissed misconduct concerns. Last year, the editors of a 2005 Neuroscience paper co-authored by Wang, Burns, and others found no improper manipulation of Western blots, but said in an editorial note they would review any concerns from an “institutional investigation,” apparently CUNY’s probe. They did not respond to additional findings Schrag raised this year.
Another paper that purportedly validated science behind Simufilam—also by Wang, Burns, and colleagues—appeared in 2012 in The Journal of Neuroscience. In December 2021, the editors corrected one figure. Barbier said in a statement that they told him they had found no manipulation. But in January, after Schrag and others raised additional doubts, the editors issued an expression of concern—reserving judgment until CUNY completes its investigation.
Schrag received $18,000 from an attorney for short sellers behind the FDA petition, who profit if Cassava’s value falls. Schrag, whose efforts were independent of Vanderbilt, says he worked hundreds of hours on the petition and independent research and he has never shorted Cassava stock or earned other money for efforts on that issue, or for similar work involving University of Minnesota, Twin Cities, neuroscientist Sylvain Lesné. (In either case, if federal authorities determine fraud occurred and demand a return of grant money, Schrag might be eligible to receive a portion of the funds.)
The most influential Cassava-related paper appeared in The Journal of Clinical Investigation in 2012. The authors—including Wang; Arnold; David Bennett, who leads a brain-tissue bank at Rush University; and his Rush colleague, neuroscientist Zoe Arvanitakis— linked insulin resistance to Alzheimer’s and the formation of amyloid plaques. Cassava scientists say Simufilam lessens insulin resistance. They relied on a method in which dead brain tissue, frozen for a decade and then partially thawed and chopped, purportedly transmits nerve impulses.
Schrag and others say it contradicts basic neurobiology. Schrag adds that he could find no evidence that other investigators have replicated that result. (None of the authors agreed to be interviewed for this article.)
That paper supported the science behind Simufilam, Schrag says, “and spawned an entire field of research in Alzheimer’s, ‘diabetes of the brain.’” It has been cited more than 1500 times. Schrag sent the journal’s editor his analysis of more than 15 suspect images. In an email that Schrag provided to Science, the editor said the journal had reviewed high-resolution versions of the images when they were originally submitted and declined to consider Schrag’s findings."
"If DrM released news now.. That would be weakness..."
Could be, but perhaps he and other insiders could get royally PO'd about their stock being beaten down by manipulators and buy cheap shares and/or issue a "Musk" like tweet warning shorts they're playing with fire.
I doubt he's wired that way.
FWIW - December 2021 - Acadia Pharmaceuticals Announces Positive Top-line Results from the Pivotal Phase 3 Lavender Trial of Trofinetide in Rett Syndrome.
"The most common adverse events were diarrhea (80.6% with trofinetide vs. 19.1% with placebo) and vomiting (26.9% with trofinetide vs. 9.6% with placebo". Rough side effects considering the target patient group.
Study treatment discontinuation rates related to treatment emergent adverse events (TEAEs) were 17.2% in the trofinetide group as compared to 2.1% in the placebo group.
Being first may not mean you're in the lead.
Motivation?
"The action today was clearly being manipulated, given the modest volume versus the large price movement."
Well balanced members of the public are naturally prone to cheer on the advancement of medical science to relieve human suffering on all fronts. If you consider the terrible impact CNS diseases inflict on a significant percentage of the population, Anavex success is easy to root for whether you're invested or not.
So what motivates those who exert concentrated efforts to undercut efforts to develop solutions to relieve CNS disease born misery? Are they unfeeling monsters? Perhaps. Are they simply envious of the brilliance and accomplishments of others? Maybe. Do they feel an altruistic need to protect what they see as the misguided investments made by the rest of us? I seriously doubt that.
Hatchet jobs are typically triggered for 30 pieces of silver to serve the agenda of those "Craps table, don"t betters" who are invested short.
Admittedly, it worked today.
G.B.
Good post... Particularly like your third bullet.
"All the recent new recruiting indicates to me that they have the data (and it must be good) and are now gearing up for eventual meeting with FDA for something like compassionate use."
These are expensive heavy hitter recruits required to support a going concern and provide assurances to the FDA they are ramping up for full production. These professional adds will bring in additional talent as they build their teams to support the various medical and business disciplines of the company.
Signs of positive developments are building.
G.B.
From Micro Cap Daily posted by Nathan on the Yahoo Board. Positive summary article on current AVXL development status.
https://microcapdaily.com/anavex-life-sciences-corp-nasdaq-avxl-running-on-berenberg-coverage-as-anavex2-73-blarcamesine-takes-on-alzheimers-retts-parkinsons/
Just a suggestion...
A well constructed news cycle i.e. a steady drum beat dropping something new every three-four weeks by Missling and his team during the second half of this year which would do wonders to support the stock price.
A nice progression culminating with end of year AD Trial results.
Realize, based on company history, it's a lot to ask.
"Educational Video News Release: Broad SIGMAR1 Platform"
Currently running 24/7 on a closed loop in a number of BP Research Departments.
R&D Day
The May 10 announcement of R&D day indicates additional details will follow closer to the event. A bit odd they haven't followed up with more information about the meeting format / access but perhaps they're operating under a cone of silence. If they knock our socks off tomorrow, the meeting delivery format will be a non issue.
"Anavex will host our R&D Day for investors and analysts on Tuesday, June 21, 2022. This R&D Day will include presentations from the company's leadership team with a focus on the company's clinical development pipeline. Additional details will follow closer to the event."
Interesting post...
Re-Posted by bigBIOboom at 9:33am today on StockTwits.
https://stocktwits.com/bigBIOboom/message/462744156
An apparent recent exchange between Flash9875 and Anavex IR. The tweet has two parts so click on the message body for the full text. As many of us have surmised, verification AVXL plans to leverage R&D day for news worthy updates.
G.B.
H.C. Wainwrite analyst upgraded AVXL to a $42 Buy rating on May 20. There's an outside chance Dr. Missling will throw them a news bone during his presentation at their conference tomorrow. If not, news is being held to spice up the June 21 event.
G.B.
Thoughts on the slow news cycle in light of upcoming R&D Day.
I tend to think Trainguy1 who posted the following on StockTwits is generally correct. His guess on possible R&D Day reveals...
"1. Confirm the ph3 Alzhiemer's disease clinical trial is completed, and the data is being compiled and reviewed in preparation for presenting the top line results (possibly on Sept 21 - World Alzheimer's Day)
2. Confirm the Parkinson's disease dementia (PDD) ph2 open label extension study is complete, and that the data is under analysis for top line release. Also indicate PDD and Parkinson's disease treatment next steps.
3. Confirm the M.J Fox-sponsored Parkinson's disease imaging study is designed and ready for enrollment. This study is intended to determine absorption and distribution details of orally administered Blarcamesine needed by neurons affected by Parkinson's disease.
4. Indicate plans for filing Blarcamesine NDAs to treat Rett syndrome in adults and pediatric patients.
5. Indicate plans for Fragile-X, FTD, A3-71 Alz trials."
If you're planning a big day to crack open the kimono for investors and analyst, you might be inclined to save up some interesting news to make the event feel worthwhile.
G.B.
"The consensus of this generous, grateful message board, for possibly becoming millionaires due to His efforts, is to deny Him his compensation package, when, as fortune would have it, would make him wealthier than expected due to the World and Market conditions. Like he planned for these difficult times to happen by delaying trial outcomes, during a pandemic, so He could profit by them."
I suspect we're all closer on this issue than you'd expect. I really hope Dr Missling and Elan Musk are going toe to toe in 7-8 years to see who tops the Forbes Top 100 Richest People list because of the secondary implications for all us small time ankle biters and camp followers.
But...
Until meaningful and material medical advances are accomplished and in the bag, I'm ok asking the good doctor to scrape by on his current $500K - $700K annual salary. Motivation is a wonderful thing and once we can all say without fear of contradiction... "We've got this". Then open the vault at Ft Knox with Dr. Missling's name on it.
G.B.
"ANAVEX will host a R&D Day for investors and analysts on Tuesday, June 21, 2022. Anavex’s R&D Day will include presentations from the Company’s leadership team with a focus on the Company’s clinical development pipeline. Additional details will follow closer to the event."
Bourbon referenced his historical interests in a small biotech, Advaxis which has experienced a dramatic rise and fall. I was also a true believer. When they were still a going concern, Advaxis hosted an annual investor day which were destination events. I traveled to a meeting in Philadelphia and a second in NYC. The company leaders and researchers presented updates on trials, regulatory efforts and clinical development. More importantly, time was provided after the formal program to engage with the company leaders up close and personal during an informal reception. They were guarded, but would share as much as they felt comfortable doing. There were a number of analyst present who followed the company and it was very interesting to get their insights. A few of the larger institutional investors sent representatives as well.
The format of the announced Anavex R&D meeting isn't yet clear. It will offer a lot more value if it's "in person" participation rather than a virtual event and hopefully some members of this board can attend.
G.B.
Thanks... Intuitive insights, uplifting post.
G.B.
I'm also anticipating material news as part of the Tuesday "growth strategy" update.
Posted on Stock Twits...
Shaky Prospects For Eli Lilly's Donanemab For Alzheimer's Disease
May 02, 2022 5:20 PM ETEli Lilly and Company (LLY)BIIB, ESALF, ESALY5 Comments4 Likes
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Lane Simonian
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Summary
At this point, Eli Lilly's donanemab performs only a tick better than Biogen's aducanumab/Aduhelm for Alzheimer's disease.
The FDA may grant accelerated approval to donanemab as it did for aducanumab based on the removal of amyloid plaques as a surrogate biomarker.
Medicare, though, will probably deny general coverage to donanemab as it did for Aduhelm based on insufficient clinical evidence.
Investors should consider selling some shares of Eli Lilly given this likely outcome.
Morgana Girl
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The chances that the FDA will grant accelerated approval to Eli Lilly’s (NYSE:LLY) donanemab for Alzheimer’s disease are fairly good (accelerated approval allows a drug to be sold based on surrogate biomarker data while further studies are conducted to determine its actual efficacy). But Medicare likely will not provide coverage for the drug outside of a confirmatory clinical trial. The reason for this is that donanemab like Biogen’s (BIIB) aducanumab (now Aduhelm) robustly removes amyloid plaques, but does not appear to slow down Alzheimer’s disease in a clinically significant manner in most patients. At best, then, the FDA may grant accelerated approval to donanemab just like it did for aducanumab based on its removal of plaques as a surrogate biomarker, but Medicare will probably deny general coverage just like it did for aducanumab based on insufficient evidence of its clinical efficacy. My overall recommendation to investors regarding any company whose primary target is amyloid is not to invest in that company, because amyloid is almost certainly not central to the pathogenesis of Alzheimer’s disease.
The main anti-amyloid contenders operate somewhat differently: aducanumab preferentially targets amyloid plaques (but can remove amyloid oligomers), Biogen and Eisai’s (OTCPK:ESALY) lecanemab (formerly BAN2401) preferentially targets amyloid oligomers (but can remove amyloid plaques), donanemab targets a form of amyloid plaques – pyroglutmate-modified amyloid that can increase amounts of amyloid oligomers, and Alzheon’s ALZ-801 (once known as tramiprosate) inhibits amyloid oligomer formation. However, the results up to this point are almost exactly the same: removing or inhibiting the formation of amyloid oligomers or plaques has almost no effect on non-APOE4 carriers and very modestly slows down the progression of the disease in APOE4 carriers (aducanumab, p. 59, BAN2401, tramiprosate). The problem is that all the anti-amyloid drugs mentioned above except ALZ-801 can also increase brain swelling and brain bleeds in APOE4 carriers. Eli Lilly has not provided a breakdown of the effects of its anti-amyloid drug based on APOE4 status yet but its overall numbers are quite similar to aducanumab.
The following numbers are from Eli Lilly’s 76 week phase 2 clinical trial for donanemab and Biogen’s second of two phase 3 clinical trials (at 78 weeks) for aducanumab. Each produced slower rates of cognitive decline but in a way that were not minimally clinically significant in most patients (even though they met their primary endpoints).
Donanemab versus Aducanumab (approximate from charts for donanemab)
CDR-SB score: .4 versus .39
Adas-Cog-13 score: 1.8 versus 1.4
MMSE: .7 versus .6
(donanemab charts, aducanumab numbers, p. 9)
Donanemab also performed slightly better in regards to activities of daily living than aducanumab although the tests used were not exactly the same. The donanemab numbers again are from a phase 2 clinical trial, but there are no reasons why the phase 3 trial numbers should be significantly different.
In the larger picture, it does not matter much what type of amyloid is targeted, how early it is targeted, or how much of it is removed. Often times, people have a considerable amount of amyloid in their brains and don’t have Alzheimer’s disease (study). The removal of amyloid from APOE4 carriers does slightly slow down the progression of the disease because they have more amyloid to begin with. They also have more oxidative stress than non-carriers. In both groups this stress is caused initially by other factors, with levels of amyloid being only sufficiently high in carriers to play some role in their disease progression (anti-amyloid drugs slow down the rate of progression in carriers closer to the rate of non-carriers early in the disease). To summarize: removing amyloid only removes one factor causing oxidative stress and then a secondary one at that, and that removal only makes a slight difference in the rate of cognitive decline in APOE4 carriers.
Politically, the question is what will the FDA and Medicare do with Eli Lilly’s data. The current FDA commissioner Robert Califf has already subtly expressed some misgivings as to how aducanumab’s approval was handled (comment one, comment two). The unanswerable question is would the FDA look at Eli Lilly’s results and say it is a bit better than Biogen’s so the drug should be granted accelerated approval just like aducanumab was or would the FDA this time not approve the drug based on a surrogate biomarker (amyloid) that has little to do with cognition (aducanumab results, p. 66). Considering that no amyloid drug to date has produced any significant benefit in non-APOE4 carriers, the logical decision would be to reject the drug for this group. Given the potentially serious side effects of amyloid removal drugs on carriers, the minimal benefit of these drugs is not likely worth the risks and therefore should not be approved for this group as well. For ALZ-801 which does not appear to have any safety issues, the decision might tip a small bit in favor of approval for carriers, but only if more effective drugs are not developed in the meantime.
For Medicare the decision seems much more clear-cut. Eli Lilly’s donanemab since it appears to perform very similar to Biogen’s aducanumab/Aduhelm would be subjected to the same strict coverage requirements (i.e. the cost of the drug would only be covered for those patients in clinical trials).
Alzheimer’s advocacy groups and scientists backing the amyloid hypothesis for Alzheimer’s disease spent a great deal of effort and capital trying to reverse Medicare’s decision but they did so not to the benefit but to the detriment of Alzheimer’s caregivers and patients. Medicare based their decision on the actual results and not on a surrogate marker of very questionable value. Slowing down the progress of anti-amyloid treatments for Alzheimer’s disease is not the same thing as slowing down the progress on effective treatments for Alzheimer’s disease. The former has been stunted by Medicare administrators; the latter was not.
Great stuff abew...
None of us should underestimate the arrogance of big Pharmas who have sunk tens of millions into amyloid plaque removal solutions. They are blindly locked on and may be dismissing any alternative possibilities.
Assuming they awake to the possibility they're being outflanked and beaten by an alternative solution, it's not unreasonable to assume a bidding war for Anavex will break out. I'm not sure they would have another choice.
Very easy NO vote on the compensation dump for the CEO. If Missling ultimately exceeds Musk in riches due to the value he creates and human suffering he eliminates, I'm his biggest fan... But not before he delivers and, in doing so, takes care of loyal share holders sooner vs. later.
Many of us on this board have seen this movie before.
Pretty sure trial participants sign iron clad NDA agreements that would jeopardize remaining in the trial if violated. Likely why news rarely leaks ahead of official results.
Let's hope the AVXL CEO has some sensitivity to the appearance of excessive largess the board has dumped in his lap for seemingly modest performance targets. His next near term move should be announcements that convince his shareholders he's worth much much more or plan to do virtual annual meetings indefinitely.
Big Pharmas blind dogged pursuit of clearing amyloid plaque as the ALZ holy grail appears to be synonymous with checking into the Hotel California.
Nice work. Thanks for sharing.
Wow... The linked chart is incredibly damning primarily to big pharma who locked onto the amyloid hypothesis and now have billions invested in what increasingly appears to be a medical dead end.
With solid AD results AVXL will generate partnership options and urgent acquisition interests.
FWIW...
Feuerstein has a long history of drive by attacks on small biotech companies. It's a stretch to suggests he does what he does because he has altruistic concerns for public safety. He might have held his fire until he had all the facts on Tuesday so as not to diminish positive clinical achievements that will ultimately benefit patients in great need.
In the end, his bought and paid for manipulative misinformation, which he had pre-prepared, is immaterial. And even after being called out by Anavex, I seriously doubt a correction will be forthcoming, which speaks volumes.
Clinical results and positive FDA interpretation of the results are all that matter.
Well said...
This may have been posted earlier. Published yesterday. FDA Commissioner questioning her own agency approval of Biogen ALZ compound. Who's on first?
https://www.msn.com/en-us/health/medical/fda-calls-for-investigation-into-its-own-approval-of-biogen-e2-80-99s-alzheimer-e2-80-99s-drug/ar-AALYpCx
Interesting read posted on Investors Village. Article questioning the thundering pharma herd that's still pursuing amyloid reduction as a primary ALZ solution. Documents medical community surprise at the broad Biogen Aduhelm approval from the FDA with a projected $56K per patient annual cost.
https://www.washingtonpost.com/health/2021/07/05/aduhelm-new-alzheimers-drug-amyloid/
The FDA motto - A puzzle inside a riddle wrapped in an enigma.
G.B.
Posted today on Investors Village.
Not sure if this was posted but it is an excellent commentary on AVXL. If it has been posted, it is a good reminder of what we have and why others want us to sell low.
Best Regards,
Gare
14 June 2021 Press Release Commentary
Today’s press release ties together multiple scientific hypotheses surrounding Blarcamesine (Anavex 2-73) and its seemingly endless potential.
Over the years, Anavex has used a robust compilation of preclinical and clinical data to lead investors through an analytic maze of therapeutic possibilities and pathways. While the S1R agonist efficacy and safety are definitively evident, investors and scientists have been left stringing together the pieces as to “how” and “why”. Finally, on 14 June 2021, “The emerging role of the sigma-1 receptor in autophagy: Hand-in-hand targets for the treatment of Alzheimer’s” was published, connecting most of these dots.
To begin, in normal (unhindered) adults, S1R expression increases with age, with the opposite being true in Alzheimer patients. The paper continues to state that S1R is likely triggered in old age when other key receptors (M1/M4 muscarinic, D1/D2 dopamine, and 5HT2A serotonin) begin to fail. In working cells, the S1R would act as a fail-safe, and correct the deficiencies of the other receptors. Through autophagy, the cell would return to homeostasis. However, in Alzheimer patients, autophagic function and S1R expression deteriorate, leading to catastrophic failure of the cell.
In the case of Blarcamesine, S1R is activated, allowing for autophagic function to continue, and the return of homeostasis – ultimately saving and repairing damaged cells. S1R modulates glutamate levels, maintains endoplasmic reticulum, promotes neurogenesis, and suppresses neuroinflammation, in addition to other effects noted later. Most critically, these effects have recently been proven in PET imaging of Alzheimer patients. Of interest, the scientific community can be assuaged knowing the S1R promotes not only autophagy, but also inhibits amyloid beta. Of interest to Anavex shareholders, Biogen’s Aducanumab which was just approved by the FDA sought (and failed) to demonstrate that removing amyloid beta resulted in better clinical outcomes. To date, Anavex has proven that amyloid beta is not the cause of Alzheimer’s, but a byproduct. Due to this, the scientific community (still latching unto amyloid hypothesis) should be pleased with Blarcamesine’ amyloid clearing, even though amyloid does not cause patient symptoms or degradation.
Alzheimer’s is multifactorial, which is why S1R agonists are likely a potent strategy at addressing symptoms and reversing pathology. To comment further on regulating dopamine/serotonin, in-patient trials with Blarcamesine has revealed significant betterment for patient daily living to include increased REM sleep and better mood. These effects have been noted by patients and caregivers alike. This aligns very well with the PET imaging – solidifying the link between these tangible benefits and return to cellular homeostasis at the molecular level.
To date, Anavex’ small 2a Alzheimer study has produced the most impressive cognitive data over any competitor. With an impressive safety profile and numerous daily living benefits, patients enjoyed 9% better cognitive scores over baseline at week 57, and 14% better cognitive scores over baseline at week 70. To be clear, some of these patients reversed decline. This Alzheimer data was correlated to a larger, phenomenally successful Parkinson’s Disease Dementia trial. Only Cassava Sciences has published data that comes even close to Anavex data, and even then, the cognitive results were not quite as robust.
Perhaps the most titillating excerpt from the paper is as follows: “in the future it may be the case that SIGMAR1 ligands (or drug combinations) targeting the activation of autophagic, and other SIGMAR1 related neuroprotective pathways, are prescribed prophylactically, in much the same way as with statins for the preventative of heart disease today (aspirin) in an effort to prevent the loss of the SIGMAR1 receptor seen during AD”.
To summarize, the newly published PET imaging results, combined with preclinical and clinical Blarcamesine data lends great credence to the probability of Anavex holding a miracle drug capable of diffusing many central nervous system (and other) disorders. With this in mind, and combined with the potential for outright prevention, Anavex has a high chance of successfully marketing their drugs (2-73 and 3-71). Revenues earned by such a platform would certainly produce a top-tier biopharma with a market cap in the 100’s of billions.
Still follow from a safe distance... One of several who held and passed on a big payday during the distant P&D run to $30. Where was Robin Hood when we needed it.
51M shares traded just two days ago would seem to indicate outsized enthusiasm by someone.
I admire the tenacity of those still active on the board daily. Feels like the ice is cracking under foot every time I consider re-entry. Good luck to the ADXS faithful.
G.B.
These larger end of day transactions use to be fairly common. Some trader accumulated small lots of shares all day then sold them to their client as a large block at the end of the day in a prearranged transaction.
Seems to reflect someone’s desire to accumulate shares.
Just another middle finger to small investors. What a sham.
If they were as competent advancing medical science as they are at rigging proxy vote outcomes we’d all be very wealthy.
G.B.
Weighing their options...?
Assuming the proxy represented managements best attempt to buy time, remain financially independent and a going concern, their reality today is very different if it was voted down. That lowball buyout offer they wouldn’t give the time of day may suddenly be a necessary consideration.
Resetting and reissuing the proxy may not work this time.
G.B.
Sound and fury aside...
ADXS has followed a tortured path to arrive at a critical juncture. The science continues to suggest real promise, but the financial state of the company is dire.
There are shades of grey on the ultimate utility of Lm but the financial demands are more binary. You either find people willing to place additional tens of millions at risk to prove out the science or the enterprise flounders due to lack of financial oxygen. If a RS, toxic financing and continued dilution emerge as the only available choices going forward, that answers a lot of our questions.
G.B.
I’ve not been following along as closely of late...
Does anyone have a sense for the sequence of events this week? Assuming a PR will come with the “new” information to be shared at the conference Wednesday afternoon.
G.B.