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“There are two ways to be fooled. One is to believe what isn't true; the other is to refuse to believe what is true.”
Amazing how these two fools, AF and JF, continue to bash Anavex: "Would like to know how much AVXL paid BIIB to run test and and therefore manufacture such silly PR."
“The person who writes for fools is always sure of a large audience.”
My confidence that Anavex will succeed is only stronger after listening to Dr. Missling today. The story continues to build up nicely; multiple avenues to pursue. Very smart about leveraging all available resources to develop trials.
Good luck to all who have faith. Our time is coming.
Hello McM. I don't believe I used "short and steady climb". I do welcome a long and steady climb to where the price should be based on what the market knows so far-and it is not $3.70.
I wish for the need for many pacemakers, I believe many on this board have been around for a while-me included, to activate because we receive fantastic news: "AVXL and ? enter into agreement - upfront payment of $100mil and milestone payments of xxxx".
Cheers and good luck!
The SEC conversation has become irrelevant based on the conclusion: "The SEC staff recently advised Company’s legal counsel that the staff did not intend to recommend enforcement action by the Commission against the Company in connection with the investigation previously described in the Company’s 2015 Report on Form 10-K." Translation: the company's officers are not under scrutiny, based on the false accusations made against them by the short army. I believe their day (shorts) will come when they get caught with their pants down when we finally get the announcement of a relevant partnership that will fund the ongoing activities of the company.
End of the SEC story, time to move on to more productive topics.
Cheers and good luck!
For those who may not be aware of the amounts of the grants the company has received. Not extremely significant but it shows that the science makes sense to people who understand it and are willing to provide funding with the sole purpose of encouraging research to find cures for such devastating diseases. Hopefully Dr. M. can secure some funding from the US government for AD. From the 10-q:
"During the year ended September 30, 2015, the Company was awarded grant funding in the amount of $286,455, of which the Company has received $143,228, and the remainder will be received in equal semi-annual installments over the 24-month commitment. The grant was received in exchange for a commitment to provide research and development for preclinical validation of Sigma-1 receptor agonism as potential treatment for Parkinsons’ disease.
The grant income was deferred and is being amortized as an increase to other income over a two-year period as the related research and development expenditures are incurred. During the three and nine months ended June 30, 2016, the Company recognized $47,767 and $113,701, respectively (2015: $0 and $0, respectively) of this grant on its statement of operations.
During the nine months ended June 30, 2016, the Company recognized other grant income of $571,093 in respect of a research and development incentive program offered by the Australian government."
You are welcome! Thanks to all who objectively contribute to help us all make informed decisions.
Yes. To bring to conclusion-finalize.
IR called me today.
Some of you may have read my post regarding an email that I sent to IR last week expressing my concerns about how the company communicates with its shareholders.
I received a call from IR (do not want to disclose the caller's name because I did not ask him specifically if I could). This was ~20 minute conversation with someone who seems to be well versed on the business of Anavex and the biotech industry in general. I asked him how comfortable he was with me sharing--obviously if he shared with me he should be comfortable sharing with others, but I just wanted to be sure-- within the forums that I exchange information with fellow investors. He was OK with it as long as he would not be miss-quoted or misconstrued, which I respect and understand. With that disclaimer and while paraphrasing, here are some of the key points from our discussion:
31 week data: Keep in mind that the results are from pooled data so it is difficult to ascertain anything conclusive. However, the main objective of this phase, to establish tolerance and safety dosage, was achieved and this encourages the company to move forward with the next steps in the process. Management is pleased about early efficacy signs but cautious about getting too exuberant; again, pooled data, relative and relatively small sample, nothing discouraging. Next step is to analyse the data at the individual level and continue to report.
Ph-3 AD trial:
• Likely to start in 2017.
• Reluctant to provide a more conclusive timeline as this is in the early planning phase.
• Will need to raise money or conclude partnership to execute.
• No immediate plan to raise cash.
• There have been discussions with potential partners. Unable to elaborate further.
My conclusions: nothing new here but confirmation that partnership seems to be the preferred avenue for funding while not discarding alternatives. Do not expect a trial to start in 2016. My prognostic is that Q2 is likely. The results disclosed last week should not be of concern for pursuing partnership. Actually, the company is encouraged by the results.
Parkinson’s -MJF study: Executing. Expect news on this in the not too distant future (weeks). I found this encouraging.
Orphan Designation indications: Rett is priority. Will proceed with Ph-2 study being that it will be of short duration (months) and relatively inexpensive, people and money, to execute. Expect news soon.
My take away: encouraging as this will give us a good indication as to where we stand in regards to not being a “one trick pony”. Revenue may start coming in sooner than expected.
SEC investigation and class action LS: nothing new to report. The company is not concerned in either situation. From his extensive experience with this type of situations, they happen a lot and most tend to quietly go away. He did mentioned that the company remains cautious about what/how to disclose information in light of the lack of conclusive resolution.
Comment was made referencing AF and other engaged in distorting the facts. These people get away with murder with no repercussions; regrettable and frustrating but just the reality we live. Agreed that the company can do a better job of, and I sensed that there is serious internal discussion as to the best way to do so, setting the record straight. He mentioned the PR last Friday. I commented that while positive, more of and with more emphasis on refuting the "lies" is needed. He agreed. He also commented that because of the complexity in analysing the results, it is easy to distort the interpretation, as it has been done.
He emphasized that the company acknowledges that it needs to do a more effective job of communicating to the public and will endeavour to do so going forward.
In summary: I was pleased to receive the call. I found the caller to be willing to tell as much as he could without getting in trouble.
How do I react? I believe the science is still viable, management continues to learn about dealing with the market place, limited resources (people/money) are a big hurdle that needs to be overcomed soon, I expect more/better communication going forward. In conclusion: I remain committed to my investment an will proceed cautiously but still optimistic that this will payoff for investors and those in need of relief from neurological disorders.
Cheers and good luck!
I agree with your point about Xena's posts.
In regards to the company being more aggressive about defending against those working to destroy it, I sent this to IR last week:
Sent: Thu, Jul 28, 2016 12:59 pm
Subject: Concerned share holder
Hello,
I am an investor with Anavex holding a large position since November, 2015. I have a simple question:
Is Dr. Missling going to address shareholders to tell us, with some specifics, what is going on in the company? I do think and expect that in light of the market reaction to the information disclosed yesterday at the AAIC, the management team needs to provide, in some detail, information that tell us a bit more than what is typically communicated through the ongoing PR's or power point corporate presentations. Here a some of the topics I/we are interested in learning more about:
- Ph3 for Alzheimer's trial. Timeline for execution, number of participants, locations, funding, etc.
- What is the status of the MJF foundation-funded evaluation for Parkinson's.
- Next steps in regards to the ODD developments for: Rett, Infantile Spasms, Frontotemporal Dementia. What about Epilepsy?
- Status of: Partnerships- I/we understand that this needs to be done carefully and without specifics, but at minimum we need to get an indication that there is activity on this front. Status of the SEC investigation and class actions lawsuits.
- Public rebuttal to some of the false claims being written by biased press with financial interest in seeing the company fail.
I primarily speak for my self but I strongly believe that I represent the sentiments of many investors, exchanging information in social media, who continue to believe in the science and integrity and capability of the management team and are anxious go get a better insight, again within the legal constraints allowed by the law/SEC, into the key activities the company is pursuing. One typically expects this to be done in quarterly earnings calls or as management sees fit based on important developments. The debacle in the stock price after the latest disclosure is one such event that in my opinion requires the CEO to be proactive in reassuring his investors about the future of the company.
Thank you for your attention and hopefully quick response. Best regards,
My name and contact info.
-------
I encourage us longs to continue to demand that the company operates more like most public companies do when it comes to informing shareholders. The upcoming quarterly update (Aug 11?) is a perfect opportunity for Dr. Missling to either hold a conference call or at minimum provide a letter to shareholders. Since we expect news to remain positive, this in my opinion can start to generate more interest institutional investors and financial analysts to invest and cover Anavex.
By the way, I have not heard back from IR but at least this morning's PR is encouraging. Still long and strong!
GLTA
I am not saying this is the reason for the PR this morning but I believe that those of us who still believe in this company need to put pressure on the CEO to be more forthcoming with information. I sent this to IR yesterday. I encourage others to do the same:
Sent: Thu, Jul 28, 2016 12:59 pm
Subject: Concerned share holder
Hello,
I am an investor with Anavex holding a large position since November, 2015. I have a simple question:
Is Dr. Missling going to address shareholders to tell us with specifics what is going on in the company? I do think and expect that in light of the market reaction to the information disclosed yesterday at the AAIC, the management team needs to provide, in some detail, information that tell us a bit more than what is typically communicated through the ongoing PR's or power corporate presentations. Here a some of the topics I/we are interested in learning more about:
- Ph3 for Alzheimer's trial. Timeline for execution, number of participants, locations, funding, etc.
- What is the status of the MJF foundation-funded evaluation for Parkinson's.
- Next steps in regards to the ODD developments for: Rett, Infantile Spasms, Frontotemporal Dementia. What about Epilepsy?
- Status of: Partnerships- I/we understand that this needs to be done carefully and without specifics, but at minimum we need to get an indication that there is activity on this front. Status of the SEC investigation and class actions lawsuits.
- Public rebuttal to some of the false claims being written by biased press with financial interest in seeing the company fail.
I primarily speak for my self but I strongly believe that I represent the sentiments of many investors, exchanging information in social media, who continue to believe in the science and integrity and capability of the management team and are anxious go get a better insight, again within the legal constraints allow by the law/SEC, into the key activities the company is pursuing. One typically expects this to be done in quarterly earnings calls or as management sees fit based on important developments. The debacle in the stock price after the latest disclosure is one such event that in my opinion requires the CEO to be proactive in reassuring his investors about the future of the company.
Thank you for your attention and hopefully quick response. Best regards,
Not sure why you are directing this at me. The author agrees with you.
The article is written by Lane Simmons in SA. I thought it provided a balanced view.
Anavex 2-73: Making Sense Of The Data
Jul. 28, 2016 3:02 PM
Anavex 2-73 appears to have stopped the progression of Alzheimer's disease for 31 weeks.
The Anavex 2-73 data requires careful analysis.
A Phase 3 clinical trial is needed.
In a day in which the Anavex (NASDAQ:AVXL) team announced positive news regarding Anavex 2-73, the company's stock dropped 40 percent. How did that happen?
Some investors may have believed this drug was a cure for Alzheimer's disease and were disappointed by the results. There has been a strong and vocal short "interest" in the stock, but neither accounts for the stock's sharp drop.
Perhaps the most important reason for the sell-off of the stock is that some of Anavex's most vociferous opponents scared investors by interpreting the poster presentation as proof for their narrative that the drug is a scam. The assertion made by Adam Feuerstein, among others, is that patients are slowly and inexorably declining while on the drug (article). But that is not what the poster graphs show (poster presentation). There was no decline in patients taking Anavex alone; indeed for the group taking Anavex alone, there was a slight increase in MMSE scores (mini-mental state examination) and no change in ADCS-ADL scores. Rather than having an additive effect, donepezil (Aricept) over time seemed to reduce the effectiveness of Anavex. As an aside, the same was also found in the recent LMTX tau clinical trial suggesting as heretical as it may sound that the sigma-1 agonist Aricept may through NMDA receptor activation actually have a negative effect on some Alzheimer's patients over time. The key to Anavex is not likely as a sigma 1-agonist but as an inhibitor of the pathway that leads to oxidative stress (by inhibiting neuronal nitric oxide synthase) (image one), (image two).
The only other substance that has stopped the progression of Alzheimer's disease at six months is Korean red ginseng. And while the action of Anavex 2-73 and Korean red ginseng are similar but perhaps not exactly the same - the long-term possibilities of Anavex 2-73 can potentially be presaged by the results of Korean red ginseng.
Anavex 2-73 average MSME score baseline: 22
Anavex 2-73 average MSME score 31 weeks: 25
Korean red ginseng average MSME score baseline: 22
Korean red ginseng average MSME score 24 weeks: 26.5
Korean red ginseng average MSME score two years: 24
(Korean red ginseng trial, see especially Figure two).
Funding for a phase three clinical trial is needed to see if Anavex 2-73 holds up with more participants, over a longer period of time, and with a placebo. But as I always argue, the lack of a placebo, a large sample size and an extended study period do not prove results but it does not negate them either.
I don't invest in stocks, partly for what happened here where some investors appeared to be swayed by a misreading of the data. But I would neither be too elated as a short nor too discouraged as a long over the actual results.
Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.
I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.
Dr. Missling,
I would expect that this will get to you as I am sure someone at Anavex stays abreast of what is being discussed about the company through social media channels.
As a long-term share owner I would appreciate some communication from you to the investment community which, within the legal constraints, would tell us what is going on with all the various activities that keep the management team busy on a daily basis. Updates on:
- AD P-3 status. Locations, recruiting, timeline, ec.
- Status of MJF foundation-funded study for Parkinson's.
- Rett Syndrome
- Epilepsy
- Funding / partnerships
etc.
This is not asking for anything not done by most companies, through quarterly financial results, shareholder updates, etc.
Please, give us something that reafirms our believe in the long-term viability of the company.
Sincerely,
Concerned investor.
First chance I have to post today. Clearly, a horrible day for the longs. That said, I still believe in the fundamental premise that A-273 is better than anything else in the market today. I will hold my position and hope that our management does a better job communicating shareholders and the market at large going forward.
Extremely disappointed, and less wealthy, but still standing strong.
8) Pay close attention to those who write about how the management is a bunch of crooks. The co is a scam. The science or the trials are flawed. They tell the truth and are always looking out for your best interest.
...or the board being concerned that he will be all out if the data is not unequivocally good as he posted earlier.
Would like to know what his definition is of unequivocally good.
Similar action to Friday last week. MM accumulating in preparation for high demand tomorrow.
Considering the current alternatives, anything that improves the quality of life to the level that A-273 has shown at this stage is a huge step forward. Is it a cure? We don't know that yet but it shows the promise of that possibility better than anything before it.
Let's keep the faith.
Thank you!
I like your balanced assessment and will be very happy if that is the near-term outcome.
There will be a lot of anxious eyes and ears waiting.
What is your take (speculation) on Wednesday's data?
Honestly, anytime one gets an 8% pop in an investment one should be happy. Did I expect more; no, I hoped for more but did not expect it as the next wall breaker is the measurable results. I do expect that to be positive based on the smoke signals we have been receiving from Melbourne and the approach Dr. M has taken to disclosing the information in two parts. I just can not believe he would want to leave the conference by presenting less than good results. If that was the case he could have done that yesterday. I believe the Dr. is a very smart operator.
Obviously, this is just MHO. The good thing is that we will find out soon enough. Until then, I continue to hold all my shares and unless it is a disaster, I will continue to hold them all until the next huge event, partnership announcement.
Cheers and good luck!
Thank you for sharing your scientific wisdom with us regular folk.
One thing that would be appreciated by the board (me in particular) would be, if you have the time and inclination, for you to provide us your view of what sets A-273 apart from some of the other ongoing or failed attempts to solve the AD puzzle.
Please continue to enlighten us.
Cheers!
Nice to see li'l AVXL bright green in a sea of red.
Anavex is scheduled for 2nd. poster on Wed. before the market closes. They would have to make poster (PR) available to the public in the middle of the trading day, which is unusual but not unheard of. In some cases a trading halt is imposed. Not saying that this will be the case, unless it is coupled with partnership announcement. As with may of our posts, pure speculation on my part.
Regardless, I expect an explosion after data is available.
Cheers!
Don't disagree with the premise of knowing your enemies.
The one thing about social media trolls is that the more that we acknowledge them, even in refuting their silly arguments, the more air time they get and manage to influence the gullible.
I also believe that JF and AF continue to lose credibility, even with their fans, the more they keep rehashing the same old about AVXL.
Cheers!
For what is worth, high of 7.62 vol 73k in pre-market. Not a bad start.
He is and it is best to ignore him. He is irrelevant.
Statistical confirmation, or failure, will come in due time. So far the goals of the trial have been achieved so there is nothing to be negative about. No issue with refuting bogus promos or unneeded pumping. Same for unnecessary introduction of FUD.
Good luck, whatever path you choose to take.
Meaningless? Billions spent in pursuing the wrong science proved meaningless. Time will tell but many of us believe that Anavex is on to something not seen before. If prior failures were the indication for not pursuing new discoveries, we would still be living in the dark ages. I hope you know what I mean.
Sure. Imagine how many "special" people who now have no hope could benefit if their lives improve so dramatically as these cases have shown. Keep in mind that all participants chosed to remain on the extended trial; no need to be too smart to conclude that they also gained some benefit.
Let's just agree that you are seeing the cup half empty and I see it 3 quarters full. It will soon runneth over. Done with this discussion.
Cheers and good luck!
Now you are reaching. I did not say it should be approved based on that. Small sample but nevertheless very positive. Do you think otherwise?
Simplicity is a virtue that many should adopt.
In full agreement. Anavex blazing the trail in the science and execution.
Yes, you can conclude that their lives got significantly better since being on the drug. Unless you doubt the accuracy of the reports you can not refute this fact.
I agree. I believe we will get improvements in MMSE scores at 31 weeks. However, even if it is only confirmation of 5 week measures is good for the purpose of moving to the next phase of trials. The PPS next week will be what it will be, I expect up but who knows. The real story is that with what we already know, A-273 has already surpassed SOC for AD, safety and efficacy. All possibilities for other therapies will be icing on the cake.
Nobody really knows what will happen with the PPS next week but there is nothing wrong with what was made public today. Au contraire, there are strong hints that the data on Wednesday will confirm what the anecdotes have been telling us. Regardless of short-term market reaction, the story of Anavex continues to move forward with a plan being well executed by Dr. M. and his team. The Dr. has been very good in delivering on the milestones he has put in front of us. Partnership coming soon.
I also believe that Anavex is blazing the trail to a more efficient and faster path to bringing breakthrough drugs to market. Keep in mind that although the development of Anavex's pipeline has been on the works for more than a decade, Missling has been at the helm for ~3 years and look how far we have come with limited funds / resources since he has come on board.
Us shareholders, should think of it this way: AVXL is not only going to make us wealthy; it will also give us the medicine to prolong our joy by slowing down, hopefully cure, many of the diseases that attack our brains and bodies, as we age, and deprive many of the joy of the golden years.
Good luck to all longs. Naysayers, you will have time to get onboard as the journey is just beginning.
Why should they pursue the Donepezil combo if it does not show increased benefits? We already know that D has many negative side effects. A-273 is about to become the new standard of care. The ginny is out of the bottle and can not be put back in. Expect lots of excitement next week.
Is not going to happen. However, anything below 10 will make anyone an early investor in this company. Imagine if Anavex was setting up for an IPO at this stage? I would expect pricing in the 20's.