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Yes, I stop by sometimes to read some posts but most of it is garbage bashing and personal attacks. Misiu has been a great poster here. Much nicer place at ST. This is truly a cesspool.
Ha! I really enjoyed your last comment on überraschen and I hope we quite enjoy the results rather than just like them.
Yes, the Rett DIY may be achievable in the US but it's a bit ambitious to try to tackle worldwide. We'll need companies that already operate abroad. Nice to know they are eager and motivated to reach out to Anavex unsolicited. Early bird gets the worm.
Yup, they don't know when but they know not today so it's safe to play. Good reason for Missling to not project a date to keep them from playing too hard. Sudden massive losses anyday for them.
Admittedly it's been frustrating with "slow as molasses" Missling at the helm; however, I'm happy with the tidbits we did get.
1) Anavex has been approached by companies interested in either partnering on or licensing Blarcamesine. The fact these were unsolicited shows they are watching and paying attention to the Anavex's MOA, results, and peer reviews. There will be some competition to get a jump to secure access to Blarcamesine before their competitors, resulting in more aggressive up front offers.
2) Kun Jin coming on board may finally be bearing some fruit. The possibility of using the OLE as a confirmatory trial would surely expedite the AA process and eventually full approval. Hope more ripe fruit comes from him being on team asap.
3) Good to hear Missling state he wanted to "surprise the market" without projecting a more definitive timeline like CTAD. I know it's frustrating not knowing more definitively but this works to our benefit. There's more uncertainty for shorts to play games since they don't know when the rug will be pulled out from under them. "Surprise" has two meanings here. First, getting caught off guard for the shorts, and second, it projects very positive results. Afterall, he did state at the ASM that we will like the results.
This corrupt FDA BP system is so broken. As we've seen lately, companies hold back more efficacious drugs so they can continue to milk the less efficacious drugs they already have out there. All while people suffer hoping for better treatment. Unfortunately, we're also going to see this with Blarcasemine. Even if they have all the analysis done (which they should - 8 months and supercomputers), instead of moving on it asap, they will shelve the data and wait for Rett in order to get the voucher; thus further delaying an efficacious Alzheimer's drug while people suffer and wait some more. Clearly the system is broken and needs overhaul.
Also, why would they not be discussing Blarcamesine with other authorities around the world (TGA, EMA, etc.) to seek some kind of approval or conditional approval, while working on Rett here? Again, is this a result of our broken system and corporate greed. I recall a statement by Missling that they are holding back with other agencies because we'll get a higher drug price in the US, thus eventually being able to set higher prices in other places. There's already plenty of profit that could be made on this paradigm shifting drug without having to hold it back to maximize profit while everyone suffers and waste away from these horrible diseases.
At the one I attended, Missling did a presentation with slides and then took questions afterwards. People just raised their hands and he called on them.
I don't think Alzheimer's approval and commercialization in Australia, EU or Asia would affect our voucher in the US with the FDA. He could focus on Rett in the US and Alzheimer's everywhere else.
It was good to be able to go back and watch the MSQ Ventures video. Both Missling and the interviewer did a great job on this. I particularly liked the two minutes beginning at min 17 where Missling sums up our P3 Alzheimer's results directly comparing them to Biogen's Lecanumab.
1) The signal of 273 was stronger than the antibody approved by the FDA called Lecanumab, and not only that, but
2) the improvement was seen a half year earlier than Lecanumab, and not only that, but
3) Blarcamesine is easier to administer than Lecanumab, taken orally once daily before bed, and not only that, but
4) there are no adverse events, unlike Lecanumab.
Missling makes it clear that the FDA has set Lecanumab as the bar and we easily clear it.
Can't wait for all the bulletproof details from Dr. Kun Jin!
Unfortunately, I don't see it reposted on MSQ Ventures. http://msqventures.com/new-events
I thought Missling did it more for Asia exposure for partnership reasons; however, them buying in is a good side effect!
Thanks Tred. I did manage to catch some if it. I agree with you, "He is communicating to the medical community and shareholders at each one that we are still on track."
I like that he continues to emphasize reversal vs halting. Additionally, commercialization has become a larger part of these conversations.
Missling at MSQ Ventures today at 9am. I'm not sure if I'll get to listen but if anyone is interested, you can register for the Zoom here. Please post if anyone garners anything of interest to shareholders from this.
Dr. Christopher Missling, President & CEO of @AnavexLifeSci, will be the featured speaker at our upcoming #MSQ #Webinar Series on April 26th, 2023.https://t.co/A3qGzP4E9a#msqventures #anavex #biopharma #neuroscience #precisionmedicine pic.twitter.com/62oCjU5S0c
— MSQ Ventures (@MsqVentures) April 18, 2023
Missling should have met with Chris Hemsworth when in Australia. Could have given him some hope and inked a potential spokesperson.
Hemsworth is looking at prevention.
"If you look at Alzheimer's prevention, the benefit of preventative steps is that it affects the rest of your life," the "Thor: Love and Thunder" star said. "When you have preposition to cardiovascular heart disease, cancer, anything—it's all about sleep management, stress management, nutrition, movement, fitness. It's all kind of the same tools that need to be applied in a consistent way."
Chris Hemsworth fans support 'Thor' star amid retirement claims after learning he's high-risk for Alzheimer's
https://www.foxnews.com/entertainment/chris-hemsworth-fans-support-thor-star-amid-retirement-claims-learning-high-risk-alzheimers
Mercola - FDA Accelerated Approval for Risky Lecanemab, reliance on drugs to reduce amyloid beta may be misguided.
FDA Approves Risky Lecanemab
MayoMobile's article linked in responses to AlzheimersReseachUK's biased post. AlzheimersResearchUK Post Not surprised all these organizations are protecting their decades old Amyloid theory. Great job on the article Mayo! Thanks for educating everyone.
AlzheimerResearchUK Says Anavex Not a P3 like Biogen. This was a response to someone asking about the Anavex trial:
There is no constant stream of money to be made in cures. BP wants to keep people sick so they keep coming back for more.
Agree, he's done everything in his power to get us to this point, and now we've dethroned Biogen as the company with the most efficacious, safe and convenient Alzheimer's drug. People are looking to place blame on Missling for the decreasing share price but it's completely out of his control. There is nothing he could have done or said differently to change that. At this moment the share price is completely controlled by forces external to Anavex. ie. Hedge funds, Big Pharma, the FDA, Alzheimer's Association, the mainstream media, etc. Whether they are individual actors with the same interests or actively colluding is a different question.
Our MOA so disruptive that it will cause losses of billions in profits selling worthless drugs, loss of advertising revenue from Big Pharma, invalidation of decades of research and billions wasted, etc. The fact that not one mainstream media outlet picked up the story says a lot. They've been gushing over Biogen's results for weeks so one would think that a company beating those results would be breaking news all over but all we hear are crickets.
There are many hurdles in Anavex's way, but Missling got us over the biggest one. He was smart to go to the TGA. The results have spoken and the cat is out of the bag with no way to stuff it back in. It's only a matter of time. "When you look back, you will understand why we did things the way we did."
They said they were waiting on one CRO a few days before so we don't know how many CROs reported already or by when. He most likely had data from many of them already and therefore, could reasonably predict by the Guggenheim conference what the final combined readout would be.
Ha, what was that loser FTX CEO Sam Bankman-Fried's networth? AF is in good company. LOL!
"Depending on source used, the minimal threshold for clinically meaningful status in ADAS-COG is ~3 points. With that said, responders (84% of patients) improving with a mean score of 4 is ultra significant. That’s 25% greater than the clinical meaningful threshold. There are no drugs that achieve even the threshold of 3 currently. Certainly not for the majority of their patient-base." MayoMobile on Stocktwits - Yesterday 5:53 PM
Prediction: FDA will not reverse their course on Lecanemab but after seeing Blarcamesine results and the fact that it's a simple pill with no SAEs and greater efficacy, Biogen will voluntarily withdraw Lecanemab.
Funny that AF's site is called STAT but that loser doesn't know a darn thing about statistics so Missling had to school him. Here's a couple of ideas for renaming his site. Opposite of "statistics" https://www.wordhippo.com/what-is/the-opposite-of/statistics.html
[ disinformation
misinformation
falsehoods
untruths
misreports
prevarication
misreport
false information
red herring
misleading information
fabrication
lie
falsity
falsification
fib
]
Yes, and Missling stated that Blarcamesine is even further upstream than they had initially thought. We can only imagine how many downstream diseases this fixes. Further upstream makes the phrase, "the restoration of complete housekeeping function within the body and is pivotal to neural cell homeostasis and neuroplasticity," even more powerful.
The Avatar TLR CC was at 8:30am, and not only that but the PDD TLR CC was at 8:30am, and not only that but the P2a TLR CC was at 8:30am, AND NOT ONLY THAT...
Yup! Here we go! Ideal to drop TLR before Monday morning so he could discuss it during the CC. Why waste time on another TLR CC later the same week when it's easier to just combine the ER and TLR? He'll be too busy taking calls from many interested parties congratulating him and trying to beat other BPs to a partnership.
Exactly, Missling has always been very conservative and careful when speaking about efficacy, maybe not so much with timelines, but definitely very tempered when speaking of efficacy. During conferences before the P2a and OLE, he would hedge saying things like he was "cautiously optimistic." He has stopped doing this. He no longer uses hedge phrases nor needs to hedge since he's just stating facts based on previous trials.
He wants us to remember facts. "I want you to remember the numbers of the doses here for a reason... placebo declined... the medium dose stopped the decline... but the high dose group was above baseline... so patients coming into the trial came out with better cognitive features. And the reason I want you to remember these doses is that it's exactly the same doses as in the upcoming Alzheimer's study. Placebo, thirty, fifty." Facts!
Exactly! He could not outright say he recommended an under 1B MC company with no revenues; however, it seems he's bullish on Anavex and secretly believes Anavex has a decent chance of good Alzheimer's results. Otherwise, he wouldn't have highlighted this company on his show, at this time, and say he "liked it" and gives his "blessing" for a spec play, on more than one episode.
He's dropping a hint (or two) to whoever gets it, and like you said, he needs to hedge because, from a cursory look and based on others past Alzheimer's results, it would seem like a long shot high risk gamble, especially with a pre-revenue company. Not everyone has had the blessing to follow Anavex for years (7 here) and see the results, biomarker discoveries, third party confirmation, peer reviews; Mayo's, falconer's and others detailed analysis, etc. play out and always confirming our MOA.
Also, after the META debacle, this would be a big win for him. He's opened the door to highlight and recommend Anavex more after a successful TLR and also gets to take a bit of credit for the wink. After a successful TLR, I'm sure he and many others will spend more time researching our company and then will be able to highlight our platform, MOA, and many other indications more accurately.
There's so many other stocks out there so no reason to waste a Mad Money segment on Anavex if he didn't think there was something interesting going on here. Easy enough to just ignore us like everyone else and keep pumping Lilly, or just bash without stating he liked it and without giving his blessing to buy it.
It's going to be very exciting times for us here soon and the excitement will last for many years with our platform, limitless indications, and 371 on deck!
Video of Cramer discussing Anavex taken on my phone from tonight's Mad Money. Sorry for the bad audio. It's a small ceiling mounted TV and an old Galaxy 8 phone. Maybe I'll buy a new phone and bigger TV for Christmas after TLR. I'm going to remove it tomorrow afternoon so if you want a copy, please download it. Enjoy!
Cramer Anavex 11/16/22
Having some technical problems. Will post the video in a bit.
The biggest tell for me was the following:
"I want you to remember the numbers of the doses here for a reason... placebo declined... the medium dose stopped the decline... but the high dose group was above baseline... so patients coming into the trial came out with better cognitive features. And the reason I want you to remember these doses is that it's exactly the same doses as in the upcoming Alzheimer's study. Placebo, thirty, fifty."
Yes, really liked his "but not only that but we also..." emphasis.
I think I'm going to have to break my wife's rule this year and start playing Christmas music before Thanksgiving. Agree with Mayo! He really pumped CTAD and wants all eyes on us.
The most confident and excited I've ever heard Missling! I wish it were on video so we could all see the grin on his face, like a child about to open a Christmas present knowing exactly what he asked for was inside, with only a box, some wrapping paper, and a bow standing between them. He really drove home that past success on PDD foreshadows success in the upcoming Alzheimer's TLD, and presented like a man with three home runs in his back pocket (Alzheimer's, PDD and Retts) with many more to come.
Interesting article and a bit over my head but my take away from the article is that the way to solve AD is by restoring upstream neuronal and cellular homeostasis!
It cites Paul Aisen, "Indeed, compounds (e.g., bapineuzumab, solanezumab, and gantenerumab) used in clinical trials to either reduce Aß42 production (e.g., ClinicalTrials.gov identifiers: NCT00470418, NCT01303744, NCT01421056, and NCT00606164) or prevent Aß aggregation (e.g., NCT00568776 and NCT00934050) have been unsuccessful in slowing down or preventing the pathophysiology of AD (Aisen et al., 2011; Mehta et al., 2017)
Additionally, we've wasted so many years down the amyloid theory rabbit hole keeping our blinders on to other areas for research. What a shame. "Failure in AD drug development so far might be related to... lack of drive to explore other pathological targets."
"Although some molecules have not yet been tested in AD models, we believe their proven MERCS (mitochondria–endoplasmic reticulum contact site) components have the potential to restore neuronal homeostasis."
Thanks for posting this. We're on the right path.
From Anavex
ANAVEX®2-73 activates the sigma-1 receptor (SIGMAR1). Data suggests that activation of SIGMAR1 results in the restoration of complete housekeeping function within the body and is pivotal to restoring neural cell homeostasis and promoting neuroplasticity.
ANAVEX®2-73 is an orally available drug candidate that restores cellular homeostasis by targeting sigma-1 and muscarinic receptors. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer’s disease.
Went back and searched through the archives for mention of a wash out period and this was the only one I found from 2015. Doesn't mean there aren't others that I missed but based on my quick scan this is what I found.
Anavex Announces Positive Primary and Secondary Endpoints were Achieved in a Phase 2a Clinical Trial
" Even though PART A was designed as a 5 week bioavailability trial that included a built-in wash-out period of 12 days and without an optimized dosing regimen, several Cogstate tests demonstrated highly statistically significant improvements. This finding was supported by a trend towards improvement in median MMSE score, which increased by +1.5 over baseline at week 5.
Positive effects on cognition were further supported by highly statistically significant biomarker effects of treatment at week 5 on one event-related potential (ERP) measure with a p-value of p<0.0007 and improvement in the P300 signal. The ERP biomarker scores improved compared to the initial data presented at AAIC in Washington, DC in July 2015, by which time not all patients had yet completed PART A."
For anyone who missed it, this was about a peer-reviewed publication from Neuropharmacology last year titled, “Future avenues for Alzheimer’s disease detection and therapy: liquid biopsy, intracellular signaling modulation, systems pharmacology drug discovery” from the series of the special issue on ’The Quest for Disease-Modifying Therapies for Neurodegenerative Disorders’. It includes a comparison to Aducanumab, Aricept and Memantine.
Anavex Life Sciences Reports ANAVEX®2-73 featured as a Disease-Modifying Small Molecule in Trials
Thanks all for the responses. Regarding a washout period, I recall them reporting in the past that patients retained their benefits from 273 after being taken off the medication for a while. I can't seem to find the PR with that information. Perhaps someone else on here knows when that was reported.
Shouldn't they have a general idea of how the trial went just by comparing the baselines of the P2b/3 verse the OLE?
They measured the baseline of everyone coming into the P2b/3 trial so they know that. Then as people finished the P2b/3 trial, they went into the OLE trial.
The secondary outcome measures of the OLE are
1. Change from baseline to week 96 in cognition according to the Alzheimer Disease Assessment Scale-Cognition (ADAS-Cog)
2. Change from baseline to week 96 in ability to perform daily activities according to the Alzheimer's Disease Cooperative Study-Activities of Daily Living Scale (ADCS-ADL)
Which means they had to measure everyone's baseline coming into the OLE. They just have to compare the average baseline from both trials and they know the TLR without even needing to know who took what dosage in the P2b/3.
If this is possible, then they would have had a general idea of how good the data was before applying for the late breaking oral at CTAD.
Thoughts?
We'll have to recruit a good group of loyal Anavexers to keep an eye out for AF and other FUDsters in disguise sneaking on to sabotage the mission and throw them out the airlock.