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I do not know, but Missling and Nell Rebowe seem to be very busy. Both were mentioned in the abstract CBD provided earlier this morning . That abstract has to do with a conference on Sunday, November 13. The Mizuho event in NY on November 14 (Anavex is one of the participants) includes one on one meetings as well as group meetings. Anavex activity has definitely picked up, and it is getting attention on multiple fronts.
I notice that the abstract that CBD references mentions ANS Biotech, Riom, France in the "Authors'' section. ANS webpage,says: "ANS Biotech is growing fast, in particular in the area of internal research projects to provide its customers with new and original services for pain management." Potentially more "collaboration" here?
Thanks for posting this. Interesting. Missling spoke at Mizhuo conference in Boston a few weeks ago, correct? We should stay on top of this. I plan to do so. This will be coming up soon November 14.
This stock will zoom upwards in the next few months.
Iandy: Innocent third parties routinely receive subpoenas in investigations and court cases. Receiving a subpoena per se infers nothing about the recipient of the subpoena. Furthermore, entities serving subpoenas on third parties or anyone else do not tip off the public in general and the criminal in particular, Martin S, about why they are serving the subpoena. Therefore, I think you must begin by presuming that Anavex is NOT the target merely because it received a subpoena. Certainly, no one has the right to presume any type of guilt just because someone or some entity received a subpoena.
Yes, shares to borrow for shorting are scarce. The Interactive Broker's fee rate is 97.32%. The shorts are all potential bulls. Seeking Alpha articles like the one issued today are a dime a dozen. Of course, they do influence some of us small fry, but whatever small influence today's article may have had is history, I think.
An elegant and succinct explanation of the Ariana - Anavex collaboration. That's all we need to know about that.
Ariana Pharma, CTCLS Ink Distribution Deal for Japan
Oct 30, 2012
a GenomeWeb staff reporter
NEW YORK (GenomeWeb News) – Ariana Pharma announced today an exclusive distribution deal with CTC Laboratory Systems covering Japan.
The terms of the deal call for CTCLS to distribute Ariana's KEM data analytics software and services technology. CTCLS, based in Tokyo, is an R&D service provider, specializing in the pharmaceutical sector.
Further details of the deal were not disclosed.
KEM, short for Knowledge Extraction and Management, is an association rules-based data analytical technology. It finds patient responder "subpopulations and biomarker signatures that statistical methods are unable to detect," according to Ariana, which has offices in Paris and in Cambridge, Mass.
"This deal with CTCLS will provide an excellent entry into Asia and the world's third largest biotechnology market," Mohammad Afshar, president and CEO of Ariana, said in a statement. "We expect the ongoing growth of Japanese companies in medicine development, diagnostics, and biomarker studies will further increase demand for Ariana’s KEM software.
https://www.genomeweb.com/informatics/ariana-pharma-ctcls-ink-distribution-deal-japan
CBD: I am cautious, but I like the way you think -- thinking big. But for a reason.
Anavex Compound to be Tested in Biogen Neurological Protection Model. See Anavex PR.
Multiple uses For Anavex Therapy - Science:
There is a scientific basis for Anavex therapy to be used for the treatment of many diseases besides Alzheimer’s, Parkinson’s, etc., for example:
"...A possible therapeutic mechanism for sigma-1 receptor agonists in neuropsychiatric diseases. Stimuli such as oxidative stress, inflammation, disturbances in Ca2+ homeostasis, and enhanced expression of normal and/or folding-defective proteins may lead to the accumulation of unfolded proteins, a condition referred to as ER stress, and, ultimately, to the development of neuropsychiatric diseases. Cognitive impairment is shown in patients with a number of neuropsychiatric diseases including schizophrenia, major depressive disorder (MDD), bipolar disorder, generalized anxiety disorder (GAD), panic disorder, post-traumatic stress disorder (PTSD), obsessive compulsive disorder (OCD), attention deficit hyperactivity disorder (ADHD), autism spectrum disorder (ASD), post-stroke depression, and delirium...."
http://www.sciencedirect.com/science/article/pii/S1347861314000176
A very informative and intelligent post. This is a post everyone should read! Thank you, dadofmarcmax.
Today's news: Let's take a realistic look at this. The MJF Foundation sponsored this. It was a mouse study. If one desires to resort to scare tactics or if one wishes to attack this, you may hear a lot of noise about it being a mouse study. However, that, a mouse experiment, is customarily a beginning point for a drug study, but this situation is different because of the AVXL 2-73 clinical trial in humans, which has established safety and delved into dosage as well as indicated signs of efficacy. All of the latter is significant!
Also, this mouse study for Parkinson's is an MJF Foundation (MJF) project. MJF is interested in finding effective treatments for Parkinson's not in promoting a single company. This foundation does its due diligence before wasting its resources on pursuing a study. The study illustrated promise. MJF would be remiss in its purpose and existence if it did not follow through once it found something that is encouraging (Shows Efficacy to Support Potential Disease Modification in Parkinson’s Disease).
This is what Professor Harald Hampel, MD, Ph.D., based on clinical data from our ongoing human trial said about AVXL in July of this year:
“This clinical data together with prior preclinical findings seem to confirm ANAVEX 2-73’s selective activation of the specific stress reducing and survival protein, Sigma-1 receptor. This seems to present a potential common pathway for rescuing major neurodevelopmental and neurodegenerative disease mechanisms, like in Autism-related disorders and Alzheimer’s disease. I believe the distinct mechanistic nature suggests the compound could be a candidate treatment for a precision medicine approach across a spectrum of different neurological and psychiatric diseases,” said Professor Harald Hampel, MD, PhD, Professor and AXA Research Fund Chair at Sorbonne Universities’ Pierre and Marie Curie University (UPMC), Paris, France and member of Anavex’s Scientific Advisory Board."
As I and others have said in earlier posts, Anavex has a drug pipeline other than AVXL 2-73, but AVXL 2-73 has potential for multiple applications. Anavex has come a long way. I believe it is important to keep all of this, and more, in mind other than worrying about the day to day, hour by hour or minute to minute fluctuations in the share price.
The MJF development is a real feather in the Anavex cap although Anavex has a way to go! Anavex is still speculative for longs OR SHORTS. But, it is a better bet for me, a long, than it was when I first bought its shares.
You are correct. I understated the TBRA buyout!
Oh, I see. The Michael J. Fox foundation laid a sucker trap. The foundation really isn't interested in a treatment for Alzheimer's. What's more, there really is a Santa Claus. Santa comes in September -- not December. In any event, longs need the shorts who will likely be bulls later. Lastly, take a look at what happened with TRBA earlier this week. TBRA earlier this summer failed its Phase 2 NASH trial (didn't meet endpoint although improvement shown), has pending Class Action lawsuits that came out of that trial, and earlier this week it was announced that Allegran purchased TRBa for a 500%+ premium. Take care!
His choice of words (or his attorney's choice) is what I expect especially considering the pending securities litigation. Therefore, I am not bothered by this language, which is to be expected considering the circumstances. I am sure that all PR statements are reviewed by an attorney, and attorneys will err in favor of toning down statements by Anavex.
September 21st, tomorrow, is World Alzheimer's Day.
If you all were in the doldrums because of the July 24 AVXL results (that were misinterpreted in my opinion), take a look at this:
TRBA too a steep plunge in July too. TBRA on July 25 failed Phase 2 NASH trial (didn't meet endpoint although improvement shown), has pending Class Action lawsuits that came out of that trial, and today it was announced that Allegran purchased TRBa for a 500%+ premium.
Shorts are not as courageous as they sometime claim to be. They always have to worry about buying at higher prices because they reach a point where they cannot force the price any lower. When they have exhausted their ammunition by selling all they can afford and buying power becomes such that it resists the pressure of the shorts they find themselves in a weak position. The weakness in such a position is that all those who are short are potential bulls.
Granted, Anavex stock share price has performed poorly since July, and Anavex appears to me to be long due oversold. That is not to say that it has bottomed for sure. Extremes may be overdone.
However, Anavec is not about to go to O or belly up as some bears or shorts have casually suggested. The science behind the Anavex drug product pipeline is sound, and all of its of various drug candidates remain contenders for treatment of serious diseases some of which have potentially blockbuster market status (sales in the billion dollar range).
Shorting this stock is long on the tooth. There is plenty for shorts to fret about.
For a partial list of some things shorts/bears may worry about regarding Anavex, please see: http://seekingalpha.com/instablog/2635921-hessmessinc/4916745-anavex-life-sciences-potential-catalysts
1a. ALZ outside funding/partnership
1b. Breakthrough Therapy Designation for A 2-73
1c. PK/PD data for 12 and 26 weeks
1d. PR regarding the start of P3 ALZ and first patient enrolled
2a. IND Approval for Rett Syndrome
2b. Rett Syndrome outside funding/partnership
2c. Start of Rett Syndrome P2 with first patient enrolled (slightly bigger catalyst if a pivotal p2)
3. More longitudinal data from ALZ P2 extensions
4a. IND Approval for A 3-71
4b. Outside funding/partner for A 3-71 Phase 1
4c. Start of A 3-71 Phase 1
5a. IND Approval for Fragile X - Autism
5b. Outside funding/partner for P2 in Fragile X - Autism
6a. IND Approval for Infantile Spasms
6b. Outside funding/partner for P2 in Infantile Spasms
6c. Start of Infantile Spasms P2
7a. 2-73 Preclinical Parkinson's results - Page 85 c.ymcdn.com/sites/www.wpc2016.org/resour...
7b. IND Approval for Parkinson's
7c. Outside funding/partner for P2 in Parkinson's
7d. Start of Parkinson's P2 with first patient enrolled
8a. IND Approval for Epilepsy
8b. Outside funding/partner for P2 in Epilepsy
8c. Start of Parkinson's P2 with first patient enrolled
9a. IND approval for MS
9b. Outside funding/partner for P2 in MS
9c. Start of MS P2
10. 3-71 Preclinical Parksinson's results
11. 1-41 Preclinical Depression results
12. 1-41 Preclinical Stroke results
13. ODD for other indications
14. Dismissal of Lawsuit
15. Increased institutional investing
Moreover, in the coming week there may be near term developments to be reported. For example, there is the conference this next week sponsored by Mizuho Securities in Boston and the Parkinson's Conference in Oregon as well. All just around the corner.
For the Parkinson's Conference, see this: http://www.wpc2016.org/search/all.asp?bst=Anavex
And for the Mizuho conference see this: https://www.mizuhoamericas.com/who-we-are/events
Yet, there is more to come. We do not know what will come. It could be good news or bad news on an Anavex drug for a particular use, but Anavex has possibilities for a number of drug treatments or applications. Anavex is not a one trick pony, and none of its drugs have been disproven. Despite all the negativity in the last 8 or 9 weeks, it is far from over from over for Anavex as many have so quickly jumped to conclude, and it is now time for the shorts to worry. The shorts have had a good streak, but that could abruptly change for a lot of reasons -- only some of which are mentioned above.
Excellent! Thank you.
I would not read too much into the wording. Mizuho is a Japanese Securities firm interested in expanding in the U.S. It is, of course, a conference for investors. I would not expect very much, if any, news for us from this conference. I do think it is good for Missling to be there. As Xena has pointed out in previous posts Japan has a large aging population and its drug approval policy is progressive and as someone said "showing up is 90%". Sanders showed up 1,000 times asking for some one to fund his fried chicken franchise. He was rejected 999 times, but he succeeded on the 1,000th try.
Mizuho Securities Co., Ltd. is a Japanese investment banking and securities firm. It is a subsidiary of Mizuho Corporate Bank, Ltd., which is a wholly owned subsidiary of Mizuho Financial Group. Is this the firm that's holding the therapeutic conference at which Missiling will be participating?
Yes, this is epic. Neuroscientists at Keck Medicine of USC have for the first time treated a total quadriplegic young man with stem cells, and he has recovered the functions of his upper body within two months. Moreover, he has experienced movement in his feet. Watch this:
Excellent. Thank you. Yes, Dr. Gold is a member of the Anavex Scientific Board.
I'm still around. Have been since the summer of 2014. Over two years. I have early purchases at .23 and .20 pre-reverse split. I have purchased other shares quite a bit higher as I learned more about the company and its drugs -- some in the $6-7 range post reverse split. Lately, I have purchased shares in the $3-4 range. I sold some shares at higher prices only to use the proceeds to purchase shares at lower prices. Ever since 2014, my share holdings have overall been increasing.
This is a shelf offering. A shelf offering makes it easier to raise funds over time in increments, as may be needed. It may be partially used over time or used in its entirety over time. Each time it is used, I believe that each use must be accompanied by a filing. I think it is a mistake to say that it will be used in its entirety, and there will be massive dilution. How do we know to what extent it will be used. The correct answer is: We do not know.
This is my understanding. The primary offering ($100,000,000) and the secondary offering (Lincoln Park) are separate. For example the prospectus says:
"This prospectus of Anavex Life Sciences Corp., a Nevada corporation (collectively with all of its subsidiaries, the “Company”, “Anavex”, or “we”, “us”, or “our”) is a part of a registration statement that we filed with the Securities and Exchange Commission (“ SEC ”) utilizing a “shelf” registration process. Under this shelf registration process, we may, from time to time, sell the securities described in this prospectus in one or more offerings up to a total dollar amount of $100,000,000 as described in this prospectus. In addition, Lincoln Park may, from time to time, offer and sell up to an aggregate of 6,754,609 shares of our Common Stock in one or more transactions."
Yes, if I am correct, it looks like just after the new S3 became public, the share price increased. However, the price increase was accompanied by volume of only 7,000 shares or so. It may be that something is up, but I will wait and see. I think it is best to be cautious. A little paranoia is a factor of survival, and remember this:
"Never let it be forgotten that real enemies may lurk in wait for even the most avid paranoiac."
I see those EDGX folks are up to it again with a 100,000 $3.03 bid 100,000 + - shares.
To enable more shares to short. The large order is placed and jerked. It appears to me that the large order is not a serious buy order. It is done to encourage some buying by others to try to run the price up and then jerk the large buy order when they see an opportunity to drive the price down shorting. Someone is taking advantage of low volume to do this.
It looks to me someone via EDGX is employing the Richard D Wyckoff method to make it appear there's heavy demand on the buy side to try to run the price up and down by juggling buy/sell orders.
EDGX order back in play 194,800 @ $3.03.
The 200,000 buy order at $3.03 disappeared. I remember this happening last week. It apparently was never filled, because the reported volume is not very high -- only about 78,000 share volume.
Note the similar pattern as last week of the 200,000 buy order at $3.03. It was not dependable last week. We should not rely in it this week. Keep an eye on this. If someone is playing games, they need to find a new strategy.
Yes, and remember the approved AD drugs only treat symptoms for the disease, and these drugs are estimated to be effective for treating some symptoms for 50% of AD patients. Think about that. Those approved drugs do not even treat all of the symptoms -- just some -- and they are effective for only 50% of AD patients in doing that.
So, why should we be upset that AVXL 2-73 may not be effective for 100% of the patients. Moreover, our patient population has been small for proving safety, and you cannot draw any definite conclusions about efficacy at this point. Thus, we need phase III to do that, and this phase must meet FDA approval.
We do have indications of efficacy. Hopefully, phase III will confirm efficacy to the satisfaction of the FDA. We do not need efficacy for 100% of the patient population -- just a significant number. For efficacy for FDA approval of AVXL 2-73, I believe all we need to show is improvement for a significant number of patients in our phase III over AD drugs the FDA has approved so far, assuming the FDA is true to its word that it wants to relax the standards for approval of AD drugs and speed up the process of approval with the caveat that it may require a phase IV post approval (post-marketing surveillance).
I agree the data should be ready in September, but I ventured a guess that it will be reported in October based on our past experience earlier this summer. I am thinking the company will feel compelled to run the wording by their attorneys because of the pending securities litigation. That may explain the delay earlier this summer. It makes sense that the company has become and will continue to be cautious about what it says due to the lawsuit. Therefore, I am lowering expectations about the next reporting date, although I may be wrong. I hope I am, and we see the report in September.
Currently, there is no approved treatment to either cure, slow or stop the progression of AD. The AD approved drugs on the market only treat symptoms, if that. Further, AD may cause insomnia and other problems. This is from the ALZ website:
''While there is no cure, prevention or treatment to slow the progression of Alzheimer's disease, there are five prescription medications approved by the U.S. Food and Drug Administration (FDA) to treat its symptoms.''......
''Alzheimer's medications do not help everyone. Research shows these medications work in about 50 percent of the people who take them for up to approximately two years.''
''...Alzheimer's or dementia may change your sleep patterns. You may have difficulty sleeping, take daytime naps, and/or experience other shifts in your sleep pattern. Researchers are not sure why these sleep changes occur. There are non-drug treatments and medications that may help improve your sleep.''
All five approved AD drugs have possible side effects.
http://www.alz.org/i-have-alz/treatments-and-research.asp
''In a disease state where progression is invariable over time, a sustained or stable MMSE and ADCS-ADL score is considered a positive outcome.
“The demonstration of an extended period of both cognitive and functional stability out to 31 weeks in a patient population that would normally be expected to experience ongoing cognitive decline is an encouraging milestone in the development of ANAVEX 2-73. The 31-week data also validates the earlier observation of improvements on tasks within the Cogstate battery. The specificity and consistency of these benefits suggest that ANAVEX 2-73 can sustain activation of attentional and working memory functions with repeated dosing in Alzheimer’s disease,” said Associate Professor Stephen Macfarlane, FRANZCP, Head of Clinical Governance, Dementia Centre HammondCare, who is conducting the study. “Of noticeable interest was also HAM-D data showing beneficial effects of ANAVEX 2-73 on insomnia, agitation and anxiety at 31 weeks, which might suggest an additional important role of ANAVEX 2-73 for the amelioration of behavioral and psychological symptoms of dementia (BPSD).”''
http://www.anavex.com/?news=anavex-presents-31-week-efficacy-data-from-phase-2a-study-of-anavex-2-73-in-alzheimers-patients-at-aaic-2016
''...no statistically significant decline from baseline was reported, which is impressive. Detailed pre-planned analysis of the pharmacodynamic results is in progress, which is one of the key factors of relevance for regulatory agencies and which will also determine the optimal dose for future studies.”
http://www.anavex.com/?news=anavex-confirms-data-from-phase-2a-study-of-anavex-2-73-in-alzheimers-patients-presented-at-aaic-2016
''With an aging population and no new dementia drugs in over a decade, the need to find treatments that can slow or stop disease progression is greater than ever.”
Dr. Doug Brown, director of research at Alzheimer’s Society
Expectations for AVXL 2-73 were too high in July at the time of the last report on the clinical trial. Many of us were expecting a cure. Absent a cure, as you can see from the above, a treatment that can slow or stop the disease progression is a remarkable achievement. We need to study the next data report for clues that I believe may occur in October, and we also need to realize that efficacy depends on completion of a phase III study acceptable to the FDA.
See this article. FDA Wants to Relax Approval Process for Alzheimer's Drugs | Health News | US News
http://health.usnews.com/health-news/news/articles/2013/03/14/fda-wants-to-relax-approval-process-for-alzheimers-drugs
''THURSDAY, March 14 (HealthDay News) -- In an effort to quickly develop drugs that could prevent or slow Alzheimer's, the U.S. Food and Drug Administration said it plans to relax the approval process for experimental medications for the memory-robbing disease.
In a proposal published online in the March 14 issue of the New England Journal of Medicine, the FDA said clinical trials of people in the early stages of Alzheimer's would only need to show improvement in tests of thinking and memory. Among these patients, who are only starting to show subtle mental declines, improvements in daily functioning would not have to be seen, The New York Times reported.
The FDA's goal is to speed development of drugs to treat a disease that has no cure, so that the millions of aging baby boomers at risk for Alzheimer's might be able to prevent or slow the degenerative disease. The FDA is taking comments on the proposal, and will possibly make revisions, but the plan is going forward, agency officials said.
Drug companies would still be required to do post-marketing studies on any approved drugs, to confirm their benefits and safeguard against any potential harms from long-term use of these medications.''
In conclusion, the above is why I believe that the market has overreacted to the July reports. So far, there is no indication that AVXL 2-73 does not work at least to some extent. However, patience is needed to see if efficacy is established, and we all should temper our expectations. If AVXL 2-73 shows any degree of efficacy, the FDA should be willing to speed up its approval.
Look at another big number bid at $3.13 -- 201,000. Following the same pattern as yesterday.
From my standpoint, I obviously think that is a very good strategy.
Ya'll do whatever you think, but I have learned that just because something happened in the past is by no means an assurance it will happen exactly that way again. Just something to carefully consider, it might be better to play some cards and hold some in your hand just in case. Then again, it depends on your personal situation. Personally, I prefer holding some or all, but I also understand that I may lose what I hold knowing that I can afford to live and fight again another day. In any event, I wish all of you the best.
Changing the subject just a tad, I think a lot of people expected a cure for AD, and they were disappointed in the last report. I do not expect a cure, but I think that slowing the progression of the disease, improving the quality of life a bit, and the other unexpected consequences make for something much better than the drugs we have now that do not work.