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AD is brutal disease that takes its time killing you, as any of us who have lost loved ones or friends to this scourge can attest.
Hopefully we're close to turning the tide.
N-7500... Agree with your thoughts. I expect the big pharmas, with huge Amyloid research investments, will be anxious to salvage any portion of their sunk costs via combo treatment agreements. 95% 2-73 and a 5% MaB formulation maybe.
https://alz-journals.onlinelibrary.wiley.com/hub/journal/15525279/homepage/author-guidelines#AFTERSUBMISSION
Excellent information and contribution to the discussion. Provides weight to Anavex Blarcasemine science being credibly vetted and then highlighted in the ALZ-Journal.
Awareness is increasing.
Interesting and in the same ALZ-Journal issue referencing Anavex Blarcamesine. Doesn't bode well for standalone amyloid clearing therapies.
Critical point - "Combo approaches may help improve their clinical relevance."
https://alz-journals.onlinelibrary.wiley.com/doi/10.1002/alz.064799
"Conclusion
When pooled together, the data from high-clearance anti-amyloid immunotherapies trials confirm a significant clinical effect after 18 months. However, this effect remains below the established minimal clinically relevant values. Safety remains an issue with 0.5% of symptomatic and serious ARIA, significantly beyond chance, despite thorough in-trial monitoring and management. The benefit/risk ratio of this class of drugs in early AD is thus questionable after 18-months. Identifying subgroups of better responders and the perspective of combination therapies may help improve their clinical relevance."
The fact the dataset was refreshed and updated with new information this week suggest positive movement. Agree, not earth shattering.
https://pubchem.ncbi.nlm.nih.gov/compound/Blarcamesine
Posted by Trainguy1 on ST.
Here is a link to the Blarcamesine data sheet that was updated on Tuesday 6-13-2023.
pubchem.ncbi.nlm.nih.gov/co
"Based on the safety profile of ANAVEX®2-73 (blarcamesine), as well as clinical evidence that the study drug will continue to benefit patients."
Good point.
There are a number of world-wide Rett focused organizations and networks whose members include physicians, caregivers and parents who support Rett patients. Todays hopeful Anavex 2-73 message will spread quickly, with urgency, throughout those communities.
Post on ST... Interesting observation.
$AVXL from Alberto Espay on Twitter... @AlbertoEspay
The 'toxic amyloid' #Alzheimers dogma:
41 Trials didn't reduce amyloid enough.
"The hypothesis wasn't really tested!"
1 Trial reduced it to just the right level.
"The hypothesis is confirmed!"
What's invisible about lecanameb?
Accelerates brain atrophy
Increases CSF Aß42
A pretty good 2023 aspirational list from a poster on the YMB. Let's keep track on how many the company delivers by EOY.
"Data catalysts between now and end of year. Full Phase 3 AD release. Peer review. Multiple country NDAs for A2-73 for the treatment of AD. Rett Phase 2/3 Data Release. Rett NDA. I would like to see Anavex, during next earnings call, confirm commercialization (manufacturing plans and sales distribution) strategy for A2-73 for AD and Rett."
Reyeton...Interesting and encouraging dataset of Institutional owners of AVXL.
The Insider Buys tab on this particular site reflects the last insider to acquire shares was a board member in early 2021. A well timed insider buy is such a simple thing to do, sends a supportive signal to the market while throwing a bone to data starved shareholders. I doubt insiders have been in a quiet period, prohibiting share purchases since 2021.
Thanks for sharing the information.
"Bourbon and Powerwalker, many thanks for the notes."
I echo RedShoulder and others thanks. Great having AVXL IHUB Board members in the room, actively engaging Anavex leadership, who now have a renewed sense for what's on shareholders minds.
"Theres a reason Dr. Missling skipped the US with trials and last time the topic of right to try came up I don't think they want the distraction right now."
TW2 - Thanks for the response. Glad your long day ended well.
G.B.
Right to try...
Thanks for the clarification. Seemed like a good idea, but they don't always work out. 2-73 medical approval for prescribed use is the best course.
Right to try...
While the bulk of the world remains ignorant of the promise of 2-73, members of this board have helpful knowledge of a medical option that can be shared with others. Someone posted in the past week about a loved one who had been diagnosed with early AD dementia. Rather than accept the current ineffective and dated SOC options. A suggested alternative is pursuit of Right to Try with 2-73.
"Right-to-try laws are United States state laws and a federal law that were created with the intent of allowing patients access to experimental therapies (drugs, biologics, devices) that have completed Phase I testing but have not been approved by the Food and Drug Administration (FDA). Prior to the passage of right to try laws, patients needed FDA approval to use experimental drugs. As of 2018, 41 U.S. states had passed right to try laws. The framers of these laws argue that this allows for individualized treatments that are not permitted under the FDA's current regulatory scheme."
"A federal right to try law was passed in May 2018. Since the signing of the bill, thousands of patients have been able to gain access to experimental therapies."
Would be interesting to know if AVXL is engaged in supporting "Right to Try" initiatives.
"I hope to be one, along with the Mrs., and everyone else there."
PW... Stay safe and enjoy the Big Apple. I'm anticipating Dr Missling will provide some positive news before the 23rd to lighten the mood at the ASM. I certainly would if I were him, but I'm not, as mrplmer was kind enough to point out.
Looking forward to hearing your thoughts on the meeting.
G.B.
Were I TGD, I'd much prefer being surrounded by reasonably happy shareholders at the ASM.
Partnership... plexrec "--Roche--what are you waiting for--?"
Swiss based with 103,000 associates deployed across worldwide operations, including here in central Indiana in Eli Lilly's backyard.
$66B in annual revenue derived from a roughly 84 approved drug portfolio. $10B in free cash.
We could do a lot worse.
"FDA" and "logic" are rarely used in the same sentence, but it's worth noting again the FDA has approved and appears poised to approved new AD mAb treatments based on truncated trials, the thinnest of efficacy results and disturbing side effects, including patient deaths.
Logic suggests 2-73 shouldn't, nor will it, be held to a different and certainly not higher standard for AD approval than the suboptimal stuff the FDA has already approved. Full 2b/3 results inside an artfully crafted Kun Jin statistical data wrapper, will prove to be sufficient to convince the FDA to grant patient access. If a P4 is part of the AA bargain, so be it, no one will balk at that.
Excellent job digesting some very dense research. Thanks...
The FDA approved Namenda for the treatment of AD in 2003. Twenty years with no notable medical breakthroughs. We believers in the medical promise of Blarcamesine should take comfort in the FDA's willingness, if not mild desperation, reflected in their recent approvals of suboptimal and alarming AD mAb medical applications. Lilly is poised to add to the mAb off ramp.
Our blockbuster AD solution has proven to be both safe and effective. The FDA should welcome our petition for commercial approval, breaking a 20 year AD medical losing streak, with unbridled joy.
I tend to agree, once 2-73 is approved for patient use, any additional parallel trial requirement by the FDA, whatever the semantics, will be largely symbolic.
Perhaps we're poised to repeat history.
Regeneron - REGN shares
$12 March 2009
$22 August 2010
$150 October 2012
$830 April 2023
If I'm a big deep pocket pharma (Eli Lilly) pushing my "Mab" concoction through the approval process, I might want to hedge my bets and partner with Anavex to gain access to 2-73 to create an effective combo AD treatment. I suppose that's ok as long as its clear which part of the combo is causing brain swelling, brain bleeds and random patient death and...which part of the combo is actually doing the heavy lifting.
One headline today... "Eli Lilly adds $23B in market cap as investors rush on promise that this will be the amyloid Alzheimer's drug that works"
Doubt any of us are surprised Lilly has the bit in their teeth and are plowing forward to gain approval of their amyloid tau removal infusion therapy. They've even served notice on the FDA when they expect to gain approval and further indicated government agencies will pony up for the Medicare and Medicaid costs. It's great to be King.
On the plus side of the ledger, we small ankle biters, who hold investments in Anavex, just saw our financial prospects brighten considerably. Big Pharma hates loose ends. If there's even a whiff our small biotech's AD treatment is a serious threat to Amyloid treatment dogma, the odds we're acquired go up dramatically.
"Lastly, please tell me what is the reasoning behind "but not before" to each individual point I just made."
Ok Wolf, Here goes...
- Institutional ownership is very low at 34%
- A partnership is always possible, but in reality, doesn't exist at this point
- Shorts are 15M strong and holding, not fleeing
- I'll add, Missling has not yet cleared up data questions from early December which isn't helping.
I hate the facts as much as you do, but those are the facts today. Hopefully things change for the better soon.
Here's tredenwater's original query for reference...
"When will the games with the pps end? When will Dr. Missling finish/release the partnership announcement of all time which MUST include now patent protected hypertension? When will the Fda receive enough data from multiple disease trials for Blarcasamine to finally give us a clear path to accelerated approval for one or more diseases?"
Your take...? "IF "hardcore, accurate, irrefutable data" were really the issue. It isn't."
We'll respectfully agree to disagree as we continue to languish around $8. Those of us who frequent the AVXL boards are generally true believers, but our biased opinions don't influence the approval process even a little bit.
Once multiple doubts about the validity of the data are fully resolved, (sorry, but the doubts persist) partnerships are possible, more institutions will buy in, shorts will flee in panic, commercialization will likely occur and the share price will go up, but not before.
I think we're both rooting for the same outcome.
"When will our pps swings have $5,$10,$20 intraday swings instead of .50-$1?"
Hardcore, accurate, irrefutable data should do the trick. All the conferences in the world with regurgitated talking points and suggestions of things to come won't move the share price, as we're all painfully aware.
Different mood and circumstances when you attended perhaps. I could be wrong, but I seriously doubt there will be loads of back slapping friendly banter and selfies this year. Based on multiple stumbles, nor should there be.
Perhaps a blockbuster announcement before May 23rd. Let's hope so.
MRP... All due respect, but companies maintain an iron grip on the ASM agenda, proceedings and Q&A. Everything is carefully scripted and no one will lay a glove on the TGD or even be allowed to ask him a hard question. That's the reality. Save your airfare.
I do however agree with others, they will be scrambling to tee up happy news for release before the meeting.
Let's trust Rett approval is very high on the list. The assumption is they want to complete the pediatric trial as the path to obtaining the $100M voucher. A worthy pursuit, but as a commenter offered on another thread...
"Pediatric Rett is a very urgent matter as these children often have a short lifespan that is punctuated by great suffering."
2H really needs to mean 2H.
Astute observation by a poster on another board...
"We are a falling feather rising slightly in the gentle 2% updraft from XBI."
Post from Yahoo...
As a long term investor, I liked the little bits and pieces of AD data presented on Dec 1, 2022. But CM offered only a thin slice. Where is the rest of the data analysis? 50 mg vs 30 mg, biomarkers, etc.? It has been 4 1/2 months, nothing new presented on April 17, 2023 conference. I did data analysis for 40 years, multivariate statistics on experimental designs much more complicated that those in this Anavex study. It typically took days, not months to do extensive analyses: Analyses that examined a priori predictions, post hoc comparisons, peeling away "the onion layers" in every possible imaginable way. Computers with recent software are insanely fast at doing these calculations. I don't understand how CM can play up the importance of biomarker measures in the April 17 presentation and then say nothing, 4 months after getting the data, about the actual results on those measures. Why was there no mention of this in the Q & A, other than that he hoped to provide a full analysis of the data this year. If additional analyses involve complicated genetic sequencing, or rocket science still in development, he ought to say so.
Publication of scientific data can take years (e.g., writing the article, submitting it, waiting for peer reviewers, waiting for the editor's decision letter, then revising the article, and then sometimes a publication lag). But the data can be presented at a conference before all of that. I am not selling, but I am not a fan of CM anymore.
Take heart avx... While the daily 3% drip, drip, drip of shareholder value erosion is painful, at least TGD is comparatively losing his a$$ as well.
With the number of open positions being recruited on the Anavex job board they're either gearing for battle or it's a brilliant stall tactic to make people think they are.
"Wow...an updated powerpoint."
TGD doesn't strike me as the type who seeks or enjoys rolling around on the floor with angry shareholders. I fully expect he's teeing up news before the SHM to calm the participants, especially since it's in person. Solid chance the Peer Review, at a minimum, will be dropped beforehand.
Lol... Yep, optimism is all we've got for now.
Solid poster Trainguy1 on ST...
"I sent several questions to Anavex IR requesting details about clinical trials. They declined to respond, but finished their reply with the following blurb, which provides optimism for Q2."
"We are working on a number of initiatives, including updating the powerpoint and releasing additional press releases, but at this time we have no further comment."
Again... Not a block buster response from IR, but I think the company will be highly motivated to provide news and updates before the SHM.
From monregi on ST...
Dear Stockholder:
You are invited to attend the 2023 Annual Meeting of Stockholders of Anavex Life Sciences Corp. which will be held at the offices of K&L Gates LLP, 599 Lexington Avenue, New York, NY 10022 on Tuesday, May 23, 2023, 10:00 a.m., Eastern Standard Time.
I anticipate material news before this date to defuse current shareholder angst.
Post from IV (AVXL Prime) - Mabs Shrink Brains.
https://www.medpagetoday.com/neurology/alzheimersdisease/103817
JJones - "That new IR guy must be hearing an earful."
Great post.
Wolf - Legal liabilities are avoided via full transparency and communicating the truth and nothing but the truth. Agree, playing fast and loose with the data or committing errors of omission is legally hazardous for Missling and the company he leads.
We all trust TGD is way too smart to make that mistake.
Just an observation... Anyone else struck by the irony that MayoMobile appears to exert more effort in analyzing and presenting Anavex data to investors, than Anavex does?
Your analysis is greatly appreciated Mayo.