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Annovis straight up recognises that a pivotal PIII trial is required!
Better for MCI. About the same for mild AD
I am sure there are people here with far more expertise that I, but I believe that Cog-13 is the preferred measure. It is my understanding that the two additional components are memory related, but would be interested in hearing from someone with more knowledge.
The stock is now down 38% and halted again. Looks like people are realizing they are no where near commercialization. EDIT - just reopened again and now down 48%.
COG-13 is a more sensitive (responsive) methodology than COG-11?
do you know why its trading so much lower. I think they didn't meet both endpoints but this was always touted as 1 of 2 phase 3s. The dose dependent improvement and biomarkers are very encouraging.
lol. You may be on to something.
Another small biotech just posted their phase 2/3 AD results. Annovis's trial is a useful comparison to ours. Note size, results, endpoints, disclosures. Also note timelines (eg LPLV mid-Feb). They have interesting things to say about their biomarkers.
Anavex or somebody should market the best ever placebo pill, the effect is real and has only imaginary side effects.
It is amazing how the mind can state influence the health of the rest of the body.
It’s a shame the placebo effect can’t be patented, but someone could claim new and effective methods of inducing it.
It is also worth noting, Ignatius, that they used ADAS Cog-11 versus the ADAS Cog-13 employed in the Anavex trial and the mAb trials.
Correction - ANVS now back down 15%. Ho hum.
ANVS reopened and is only down 5% now. AVXL is barely up. The market just doesn't care about AD.
They missed the endpoint in ADL CGIC and blamed the high placebo effect.
Yup. Get ready for some fireworks.
If they have good news it could spark a rally for AVXL...just like SAVA did three years ago. AVXL actually hit its highest SP of $31/share due to SAVA's good news.
Buckle up. This could go either way.
Annovis Bio Announces Statistically Significant Phase II/III Data in Patients With Early Alzheimer’s Disease
ANVS halted pending news - down 16%.
We both know how he exposes shareholders to unnecessary risk with his method.
Either we hit the targets in 2A/B or we didn't. You can put a shine on sheet. Release the data!
Nidan we all feel that lack of transparency is killing the stock
“This has really turned into a crap shoot!”
I agree with your first, second, third, fourth, fifth and seventh words.
You’ve decided to invest in Anavex knowing that it’s a speculative biotech and that you could lose your investment. I don’t have an issue with that. Good luck. But normalizing Missling and basically saying he’s no different than other biotech CEOs, or blaming Adam Feuerstein and hedge funds, is wrong. Missling’s track record, which I’ve urged you to spend some time reviewing, is not just like any other CEO. Confirmation bias to justify an investment is a recipe to lose money. Please do yourself a favor and study Missling’s work history prior to Anavex and his track record since joining Anavex. If you look over his work history you’ll see that he rarely spent more than a year in any job. He was also a senior executive at an investment bank that was shut down by the SEC. In some instances he lasted just a few months. Don’t take my word for it. You can Google it. With some effort, you’ll find it. If you do that, I think you will see that Missling is at the tail end of the bell curve when it comes to CEO performance. It’s one of the reasons I believe he should be replaced.
Again, I’m not saying don’t invest. I’m simply telling you to at least get a clearer picture of who you’ve entrusted with your money.
He's no different than most CEO's in that way, most quarterlies are scheduled on or near the last day they're supposed to report. I live in L.A., decades ago most quarterly and other presentations were scheduled about a half hour after the market closed. Suddenly I found most companies switching to an hour or so before the open. I asked my broker what was going on and the explanation was simple, nearly all the Analysts are on the East Coast and nearly all come in well before the bell to get up to date on the news. They complained that when the day ended they wanted to leave, not wait around for nearly two hours to first read the financial, then listen to the quarterly report which followed the release.
While I'm interested, I don't get up at 5 a.m. to see the release, or 5:30 to hear the call, and only rarely am up when the market opens at 6:30 my time. I may use the bathroom about then, so I'll take a glance, but unless I find a big move in one or more of my stocks I just go back to bed until I normally wake up, 1 to 3 hours later. One of these days, if I miss the open, when I do wake up I'll learn I'm half a million or more dollars richer, from NWBO news, I don't own enough AVXL to make that sort of gain, at least not yet.
Gary
Missling is sloppy with his timing. He doesn’t think when he picks dates for CCs. Several times he had CCs on strange dates like before holidays and weird times like switching to an 8am on a Monday, not thinking investors read into these moves.
They all have been a nothing burger, while we all got excited expecting something since he telegraphed.
I hope there’s something here this time.
Or maybe he was just like, oh crap, we got to do the ASM. Shiit, I knew I should have never fired my secretary.
Powerwalker, clearly they'll be speaking with a quarterly in the next two weeks, but how much they can reveal above and beyond a normal quarterly may be in others hands. If no material or data that's never been peer reviewed is released, they're limited about what they can say. On the other hand, if they're in control of an issue, like filing with a regulator, they can certainly update about that.
I know that when they discuss million page filings there are companies that specialize in getting them out, just the announcement that such a company has been engaged would be positive news rather than trying to do it all themselves. I'm frankly unsure if even the BP's do it themselves. If they were to announce an intention to file somewhere no later than say the end of the third quarter, it would be greeted positively.
If you're right about discussions with one or more BP's, it would be big news to indicate they're in a quiet period, so it's cannot be discussed. Sometimes the best news available is that we're not free to discuss anything. During such periods they're still required to issue financials, but the failure to say certain things in the financials may be telling a story by itself.
I do suspect that sooner, or later, a BP will either partner, or look to buy the company. Personally I would like the price much higher before it happens, but that can only happen with one or more approvals. Offers very rarely pay more than double the current price, I would hope the company's trading in at least low double digits before considering any offer. Under confidentiality agreements, a potential partner, or buyer, would gain access to all the data we're being denied until it's peer reviewed. That's information that could lead to a much higher offering price, but only after the stock price reflects the news that's not yet been released to investors.
I for one believe that when we get the full story on RETT's we may see a possible path to approval without further trials, but that's purely my opinion. On more than one occasion the regulators have agreed that more than specific goals in a trial should be considered if a product has some benefit where nothing else exists.
Gary
True and been in it over12 years so I know what your saying!
Your insights are invaluable.
P.S. I am wondering, after the Rett January numbers, which were better by ~ 3x than those of Acadia's, whether Dr. Missling, his staff, the lawyers, et al realized that Anavex was batting against Sandy Koufax with a whiffle ball bat and its strategy needed to be altered.
BP has many different ways to "influence" a trial and it wouldn't surprised me if it did here ... with the results, Dr. M understood that fact and is looking to bring in some heavy muscle, e.g., Merck, Takeda among others. Just a thought ...
Gary, this is not a NWBO scenario. Anavex will need to be forthcoming in the next two weeks as to its current situation. If not, it will need to be specific as to why no data is being revealed. If Anavex were still ambiguous, there will be more lawsuits directed at the withholding of material evidence, which might be easier to prove than the ambulance chasers as there are dates when data is known and whether it were disclosed or not.
Hopefully, in the next 7-10 days, this will all be clarified.
It's biotech. It always has had significant risk.
Contrary to popular whining, I think the overall level of risk has been reduced considerably.
Alas, it's not done till it's done.
Only if it's another Rett scenario. And if it is Missling will be sued into his grave.
This has really turned into a crap shoot!
Powerwalker, I'm sure you're right about the company doing the quarterly webcast in a timely way, and yes, they certainly speak with investors whereas NWBO doesn't do such webcasts, so all you get is the written text. As for the Annual Meeting, if Missling gives investors a reason he'd prefer to wait, I believe investors would support it.
Investors want to hear more about the data, until that data's been presented for peer review, the company shouldn't do it. Wouldn't you rather have a Journal out, or peer reviewed presentation first, then have open discussion of the data, or have the meeting and be told that the data won't be discussed until it's been peer reviewed.
I don't believe Missling will delay more than a few months, but I'd rather have a meaningful Annual Meeting in perhaps August or September than a meaningless one in May, June or July.
Another possibility does exist, but only after peer reviewed data's out. Hold a Science Day. It's really just a few hours, but allow the scientists to do far more of the presentation. I don't know them, but hopefully among them there are better presenters than Missling. I know other companies have done Science Days so when the time's right, why not AVXL.
Gary
Not really...we expect after 5 years from trial end that we can at least get a drop of data. So you must not have dug deep enough..
Gary, I don't know about the NWBO activities that you mentioned or its responsibilities to report, though several NWBO posters have been here in the past and have brought their complaints and/or optimism.
What I do know is that Anavex has a date of May 10th for Q2 numbers plus a CC and if it weren't released/conducted with some news on the ASM, our NYC shareholders would set up a date to meet in Manhattan and storm the Anavex offices. [My wife and I might join them from NW Indiana.] If a delay were announced and no valid reason provided, the stock gets hammered to pre-RS levels as it is easier to FUD then defend when that happens.
Therefore, Dr. Missling, give us something to hang our hats on in the next two weeks.
Were any of the CEOs you advised members of the upper echelons of biotech investors?
Your posts reveal that you were quite the consultant. Forgive my incredulity.
Bio4, if any of that were true as to your career, you would NOT be trolling any message board with your "best intentions." You would be long gone into a wealthy retirement and there would be no need to be here ...
Unless, you were a lousy management consultant and were not able to ID the right guy more often than not. Actually, given your posts over time on the Anavex board, that is probably the case ... and, you are missing again.
I pity your poor sign ... No, you probably don't have any one tied to you ... each one saw you for the loser you are!
Really? FYI, I spent my entire career working as a management consultant to senior executives and coaching management teams on organizational issues. I’ve seen my share of good CEOs, mediocre CEOs, and bad CEOs. There’s plenty of mediocrity out there but there are some great CEOs and some terrible CEOs. It doesn’t take me very long to size them up.
I completely agree with you Chris. Any CEO would prefer to have their Annual Meeting after some good news, rather than when under fire for nothing new happening. On the Nasdaq a CEO probably doesn't have the freedom an OTC stock does, in NWBO's case they didn't have a meeting in 2023 after holding the meeting for 2022 on the last business day of the year, but I suspect that Missling can delay a couple months without a serious penalty. I believe if shareholders wish to force the issue 13 months after the last meeting they can sue, which will take time, but ultimately they can force the meeting, If I were Missling and I expected a Journal publication at any time, I'd wait until I had it unless I had something even bigger to announce, like actually filing for approval.
As for Missling's ability to be CEO, some will deem him a failure right up to the day the company gets it's first approval, then everyone becomes a hero. I believe that CEO's are given entirely too much credit, or blame for what most companies do. If they put together a good mix of the right people, it's all of them that are doing the job. Ultimately it's the science that determines if a product is really approvable, I don't know Missling at all, but I doubt if he contributed much to the science that's produced the company's products.
Sadly, in at least a few companies I've seen good science fail because companies tried to gain approval quickly by using pancreatic cancer as the target for products that worked far better against cancers that took much longer to kill. The company didn't have the funds to do the additional trials so the products were abandoned and the company went belly up. Missling has the company well positioned financially, now the science must prove worthy of approval, I believe that's happening.
Gary
And you are uniquely unqualified to evaluate the CEO.
Missling is uniquely unqualified to be a CEO. I urge you to take some time and look at his career track record prior to joining Anavex. As CEO of Anavex, his performance has been dismal. It’s been one fumble and stumble after another. It’s not the fault of investors that the stock has collapsed, nor is it the fault of Adam F or hedge funds. Missling alone is responsible for the destruction of shareholder value. I know it’s a lot of work but do yourself a favor and study his performance over the course of his career and tenure at Anavex before coming to any conclusions.
You are 100% right on with your views. I would add a couple of other points. The companies silence along with the shareholders meeting, not being announced yet lead me to believe something larger else is going on. Maybe it’s the preview being released maybe it’s a partnership, maybe it’s guidance from the FDA or submission to the EMA. But clearly somethings gotta give one way or the other and I suspect it will be positive for the longs. Stay tuned.
As a reasonably new investor in AVXL I've seen a great deal of criticism of the CEO, but honestly it's nothing that I haven't seen in other biotechs, and in most cases it's been for the same reasons. In most cases it's because investors believe that once a trial end, they're entitled to in depth trial data. In reality, the company does give Top Line Data, but that's just a paragraph or two summarizing what's seen in the trial, after that, once data's been peer reviewed and presented, then they can talk about it.
Sadly, companies want the peer review to be done by organizations deemed to be highly respected, and they'll wait for them rather than finding the first conference or Journal willing to permit a presentation. I'm much more familiar with Oncological products, and there conferences like ASCO are where they want to be. I'm sure much the same applies here, though I don't really know the key conferences, or publications they're working to get into. My point is, it often takes many months, sometimes in excess of a year to get the data presented in the manner they wish it to be, and until that happens they simply would be violating proper protocol to discuss them beyond what's in that TLD statement.
When a peer reviewed presentation is made it won't be just the positives, it will be a review that has positives, negatives, questions, etc. seen in the trial, it's rare that nothing negative can be found. Peer review will cite both good and bad, that's what it's all about. Competitors, who fear approval of a competing products may have their own "experts" develop presentations that counter the good as well, money will buy almost anything, and some lessor publications or conferences will accept what's provided and consider it peer reviewed by their staff.
Finally there are the geniuses like AdamF, with his degree in PoliSci, as I remember it, that work in support of shorts to put down companies who put their spin on the results, and sadly many people do follow them, as well as the hedge funds that no doubt employ them.
In time, all of this becomes meaningless if the company applies for approval with the regulators, and gets it. When revenue builds, that's something that can't be denied, but until that happens, one minute the CEO's terrible, the next he's brilliant, it's all dependent on the current stock price.
Gary
Misleading and his shenanigan continues, he is been doing this for last 20+year, he is pro in scamming retailer with slogans. Lately, he has been using social media platforms like Facebook, Twitter, etc., to pump the stock price with the aim of enriching himself. It's important to recognize this pattern, which has been evident since December 2022.
MF has not invested single penny to buy the stock in the open market.
Barons doesn’t know more than the rest of us. Based their 12 months $AVXL forecast the MAA filing and validation feels like $40 in their analysis, which would be fine.
Will it happen? We wait to see…
ANVS secured non-diluting funds for future trials. Class act their CEO which has invested her own money into the company total opposite of “TGD” which has diluted the shit out of Shareholders with no approvals on sight this year or 2025.
I'm certainly no expert, but I suspect that many of those pages are generated as a product works its way from preclinical development through clinical trials. They essentially provide the backup to significantly fewer pages that are the real guts of the filing. On the 1.7 million pages in the NWBO filing almost everyone I discussed it with agreed that less than 10% will probably see the light of day.
Gary
Power the Anvs board has the filings. They appear to be favorable towards the company and the timing of the data release is a primer. I pray they do not have any hiccups in their data.
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Anavex®Life Sciences Corp. (the “Company”) is a clinical stage biopharmaceutical company engaged in the development of differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental diseases including drug candidates to treat Alzheimer’s disease, other central nervous system (“CNS”) diseases, pain and various types of cancer. The Company’s lead compound ANAVEX®2-73 is being developed to treat Alzheimer’s disease, Parkinson’s disease and potentially other central nervous system diseases, including rare diseases, such as Rett syndrome.
Anavex®Life Sciences’ lead drug candidate, ANAVEX®2-73, recently completed successfully a Phase 2a clinical trial for Alzheimer’s disease. 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. It has also exhibited anticonvulsant, anti-amnesic, neuroprotective and anti-depressant properties in animal models, indicating its potential to treat additional CNS disorders, including epilepsy and others. The Michael J. Fox Foundation for Parkinson’s Research has awarded Anavex® a research grant to develop ANAVEX®2-73 for the treatment of Parkinson’s disease to fully fund a preclinical study, which could justify moving ANAVEX®2-73 into a Parkinson’s disease clinical trial. ANAVEX®3-71, also targeting sigma-1 and M1 muscarinic receptors, is a promising preclinical drug candidate demonstrating disease modifications against the major Alzheimer’s hallmarks in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid and tau pathologies, and also with beneficial effects on neuroinflammation and mitochondrial dysfunctions.
The Company is in preparation for ANAVEX®2-73 for a Phase 2/3, placebo-controlled trial in Alzheimer’s disease as well as a Phase 2, placebo-controlled trial in Rett syndrome, for which the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) for ANAVEX®2-73 and a Phase 2, placebo-controlled trial in Parkinson’s disease.
Headquartered in New York, Anavex® Life Sciences is an American publicly traded corporation on Nasdaq quoted as AVXL
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