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You are not being sued for fraud. I would prefer he continue to work diligently on the science that matters.
It's 3,250 post-split, and no, he has not sold them as per his filings:
http://www.sec.gov/cgi-bin/browse-edgar?action=getcompany&CIK=0001196573&type=&dateb=&owner=include&count=40
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Or is it ANAVEX PLUS already available OTC for $2 a pill?
Not to mention the CEO bought 13,000 shares under a 10b5-1 plan. Did he sell them @ $14? No. Did Uncle Tom unload? No. Show some evidence of impropriety by the company and maybe they'd have a case.
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How did Anavex defraud investors? What misleading material information was presented? Things like, "...could potentially halt or reverse the progression of the disease" are well-covered within the FLS clause. What revelation of untruth was revealed that caused the price to drop? The November data release was as good as the market expected. There was no catalyst to cause the market to react the way it did. No "bad news". The cabal started up the NSS time machine to put the price at a level desired by them.
No, there is no fraud case here and Judge Furman will see it expedited off his docket, pronto. The CEO has better things to be concerned with and he already released a statement, which was more than enough. The stock price is not the business-at-hand.
http://www.bloombergview.com/articles/2014-06-23/there-will-always-be-stock-drop-lawsuits
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Will be Dr Fisher. follow this thread:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=120620168
Abraham Fisher
Israel Institute of Biological..., Ness Ziona
https://www.researchgate.net/profile/Abraham_Fisher3
ANAVEX 3-71
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No shares for sale. BATY going batty! §
Oh, thanks Mikesc. Did they just post it or was my cache stale?
I'll look it over at lunch.
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es one's only 432...435....436 pennies! it's starting to go banannas
438...
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I assumed the Friday conference would present the former preclinical Epilepsy findings. Instead, we get another surprise independent study in an orphan indication. This is outstanding!
The poster is not on the website yet, so the market has not seen it.
Don't worry, you're AD data is coming!
And papatroll is getting roasted...
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You better believe it!!!
I think we are only 13 days away from HUGE NEWS!
Masterful management comes prepared.
Up 1% for every 100KK? Can't beat that!
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ed- +3.5 MMSE, +7 ADCS-ADL is my guess, btw
Hear that, Mr Cortina?
It looks like a poster session before rolling 10 min stage/slide presentations in the meeting room. Notice all the presenters are 10 min slots.
12:15 – 2:05 Networking Lunch and Poster Session
2:05 – 4:45 Session IX: Clinical Drugs
Moderator: Michael Privitera MD
2:05 – 2:15: Diazepam Nasal Spray for Cluster Seizures – Rajesh Shukla PhD, Acorda Therapeutics
2:15 – 2:25: Epidiolex (Cannabidiol, CBD) – Kenneth Sommerville MD, GW Pharmaceuticals
2:25 – 2:35: Cannabidiol oral solution – Deborah Lee MD PhD, Insys Therapeutics
2:35 – 2:45: Carbamazepine IV – Jouko Isojarvi MD PhD, Lundbeck
I would think it will include the poster on the preclinical findings as well during that session. Yes, let us wish that the day includes the announcement of a funded trial.
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What do you think of the new corporate relations collaborations?
Investors:
Jenene Thomas
Jenene Thomas Communications, LLC
908- 938-1475
Email: JTC@jenenethomascommunications.com
http://www.jenenethomascommunications.com/
https://www.linkedin.com/in/jenene-thomas-4a25065
Media:
Jules Abraham
JQA Partners, Inc.
917-885-7378
Email: jabraham@jqapartners.com
http://www.jqapartners.com/
https://www.linkedin.com/in/jules-abraham-02045b2
When I was a Chef my favorite saying was, "I don't F#%$-around!". Missling is building a young business with young, brilliant people. He doesn't appear to be fusilling-around in his kitchen.
Congratulations Dr Favus on the options vesting. And, of course, thanks to Mr Skarpelos, without whom none of this would be happening. Happy anniversary Uncle Tom!
Effective January 25, 2007, we completed a merger with our subsidiary, Anavex Life Sciences Corp. As a result, we have changed our name from “Thrifty Printing Inc.” to “Anavex Life Sciences Corp.” We changed the name of our company to better reflect the direction and business of our company.
“Remember, you cannot be both young and wise. Young people who pretend to be wise to the ways of the world are mostly just cynics. Cynicism masquerades as wisdom, but it is the farthest thing from it. Because cynics don’t learn anything. Because cynicism is a self-imposed blindness, a rejection of the world because we are afraid it will hurt us or disappoint us. Cynics always say no. But saying “yes” begins things. Saying “yes” is how things grow. Saying “yes” leads to knowledge. “Yes” is for young people. So for as long as you have the strength to, say “yes'.”
-Stephen Colbert
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You should tell my brokerages they made a huge mistake then.
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Nice...peer-reviewed validation. Thanks Mikesc!
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Thank you George. Excellent links, as usual. You are a rock!
Having exclusive rights and a compound patent on A3-71(AF107B) means accelerated development and commercialization, if possible. The success of the lead compound(A2-73) could prove pivotal in Anavex becoming a breakthrough CNSD pharmco.
After diligent pursuit I have concluded the ANAVEX PLUS patent is on it's way toward allocation. It is just a matter of steps. Google {Patent Obviousness Secondary Considerations} and read this article for more info:
http://www.insidecounsel.com/2014/12/05/11-cases-that-have-set-the-standard-for-obviousnes
I believe Dr Vamvakide's patent apps are nothing more than an attempt to secure rights should the Anavex patent(s) be held up past the expiration of the original Greek patent in late 2017. This would allow him to re-negotiate his royalty terms, but the development rights would certainly stay with Anavex as litigation against a different asignee would not be in his interest. It won't happen, Anavex will get the PLUS patent this year and Dr V will let the new app go abandoned.
The company just has to figure out how to release this 12 week data without all Heaven breaking loose!
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If I was on the board...R/S.
Jeez, hope you're right. Kid will love that, but he'll still need to go to college!
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Precisely JohnCM. And it will happen here. And the big fat R/S. Just a matter of time. That's not to demean the long term buyout by big pharma(cy). But perspective is out the window on this here-un right now!
GLTA
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If the focus of the 12 week results will be on the biomarkers, as it has in the past, then Bman49ers makes a good point. There is a strong effort being made to substantiate the COGNISON and COGSTATE biomarker platforms in small cohort early detection and treatment methods. One of the companies main aims is to help design better and more efficient trials, per the guidance. Another is to help the partners achieve clinical recognition so other promising developments do not have to go through the same rigors.
Again, making news is the least of the company's concerns right now. Thanks, partially, to this board.
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That is a problem with multiple indications. Substantial efficacy in one will lead to speculation about others. If the compound fails in the lead indication you know what the chart looks like the next day.
They must have the full cohort 12 week data now. If the results will help bolster attention in the other (A3-71) compounds it would behoove the company to consider the timing. We have not officially announced the pursuit of A2-73 in MS so I don't think there is any consideration being given to releasing the 12 week data before tomorrow's presentation.
I do believe there is a BTS interest in the MS indication and they are eager.
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Yes, this is quite obviously Dr Fisher speaking on A3-71.
Thursday, March 10, 2016
Room HESPERIDES
tba (Ness Ziona, Israel)
A unique target for a comprehensive therapy of Alzheimer’s disease: concomitant
activation of SIGMA/M1 muscarinic receptors
www.siumed.edu/cpd/alzheimer/program.html
Whether it be the company or conference organizers, Anavex's participation in some events is being kept as low-key as possible, that is obvious.
I see the announcement of the CCS event this far in advance as very good news. This is one of the largest international events and would be an excellent venue for potentially pivotal data.
Yes. The Miami conference still could reveal the 12 week data.
http://worldeventsforum.com/addf/drugdiscovery/
Up 10% on <1MM is speaking "volumes" about the float.
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Abraham Fisher
Israel Institute of Biological..., Ness Ziona
https://www.researchgate.net/profile/Abraham_Fisher3
Seems you are on to something!
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And a hint from Missling three months in advance?
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Anavex has posted an announcement of the CCS conference:
http://www.anavex.com/?events=33rd-camerino-cyprus-symposium
Likely a pivotal data release
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=120294346
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Also, ACT-AD is a media partner and we are sponsors of the coalition:
http://worldeventsforum.com/addf/drugdiscovery/supporters/
http://act-ad.org/resources/q-anavex/
Probably quick announcement, small poster session...low key.
Everything is centralizing around NYC now, with trips to da beach
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Big day for Anavex!
Might get a little confusing with the new MS indication announcement...AVONEX® and-all!
Top of the order is our apparent new IR relationships:
http://www.jenenethomascommunications.com/
http://www.jqapartners.com/
Looks like we will be gratuating in this area and leaving Primoris and that whole mess behind. A new number for a "Research and Business" dept. Ms Rebowe and Mr Klamer have been busy, I guess.
On to the curiosity of the MS indication. This preclinical study was apparently privatley funded, so I dug a little and found htis blurb concerning the study authors:
http://prognosis.med.wayne.edu/article/drs-benjamins-lisak-secure-dmc-foundation-award-to-expand-scope-of-ms-project
Not sure if it is related. Perhaps this is part of the work Dr Ulrich Elben is bringing to the table as he "oversees the pipeline development and optimization". He came from Sanofi and was involved in the development of Aubagio.
Speaking of sunny Florida, there is still the possibility we will get a 12 week update at 10th ANNUAL DRUG DISCOVERY FOR NEURODEGENERATION CONFERENCE.
In patent news, it seems the delivery of the Greek patent app was in immediate response to the request for such, as indicated by a recent Transaction History entry:
01-27-2016 Request for Foreign Priority (Priority Papers May Be Included)
Sorry nothing more exciting to report.
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ANAVEX 2-73 Preclinical Data in New Indication to be Presented at ACTRIMS 2016
– Preclinical data relevant for multiple sclerosis and other neurodegenerative diseases –
NEW YORK, NY – February 17, 2016 – Anavex Life Sciences Corp. (Anavex or the Company) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative diseases including Alzheimer’s disease, other central nervous system (CNS) diseases, pain and various types of cancer, today announces the presentation of data from a preclinical study of ANAVEX 2-73 for potential use in multiple sclerosis. The poster will be presented by the study’s lead investigator, Robert Lisak, M.D., Professor of Neurology at Wayne State University School of Medicine (Detroit, Michigan) at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2016.
Poster Details
Title: “Sigma-1 Receptor Agonists Inhibit Oligodendrocyte Cytotoxicity Induced by Molecules Involved in Cell Damage in Multiple Sclerosis”
Date/Time: February 19, 2016
12:30 p.m. Central Time
Location: Hyatt Regency New Orleans, Storyville Hall
601 Loyola Avenue
New Orleans, Louisiana 70113
The poster was authored by Dr. Lisak and his Wayne State University School of Medicine colleagues, Liljana Nedelkoska and Joyce A. Benjamins, Ph.D. The poster is available in the publications section of the Anavex website.
About Multiple Sclerosis
Multiple sclerosis (MS) is a chronic autoimmune disease that causes damage to nerve fibers in the central nervous system (CNS), including the brain, spinal cord and optic nerve. This can disrupt communication between the CNS and other parts of the body, resulting in a wide range of physical and cognitive symptoms such as muscle weakness, visual loss, poor balance, chronic pain, tremors, short-term memory loss and other difficulties associated with dementia.
About Anavex Life Sciences Corp.
Anavex Life Sciences Corp. (Nasdaq: AVXL) is a biopharmaceutical company dedicated to the development of differentiated therapeutics for the treatment of neurodegenerative diseases including Alzheimer’s disease, other central nervous system (CNS) diseases, pain and various types of cancer. Anavex’s lead drug candidates, ANAVEX 2-73 and ANAVEX PLUS, the combination of ANAVEX 2-73 and donepezil (Aricept®), are currently in a Phase 2a clinical trial for Alzheimer’s disease. The drug combination ANAVEX PLUS produced up to 80% greater reversal of memory loss in Alzheimer’s disease models versus when the drugs were used individually. ANAVEX 2-73 is an orally available drug candidate that targets sigma-1 and muscarinic receptors and successfully completed Phase 1 with a clean safety profile. 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 convulsive epileptic animal models, indicating its potential to treat additional CNS disorders, including epilepsy and others. The Michael J. Fox Foundation (MJFF) 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. Further information is available at www.anavex.com.
Forward-Looking Statements
Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks set forth in the Company’s most recent Annual Report on Form 10-K filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Anavex Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.
For Further Information:
Anavex Life Sciences Corp.
Research & Business Development
Toll-free: 1-844-689-3939
Email: info@anavex.com
Investors:
Jenene Thomas
Jenene Thomas Communications, LLC
908- 938-1475
Email: JTC@jenenethomascommunications.com
Media:
Jules Abraham
JQA Partners, Inc.
917-885-7378
Email: jabraham@jqapartners.com
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The float-lock rally will be awesome!
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Agreed. And they have the $$$!...the seniors. Wasn't inferring genetics, more like the effect of caring for the elderly on the hyper-productive Asian population. Easier for westerners to care for their elders, economically.
Asian populations are hardest hit by dementia. Done any DD on this $670K from AU being amortized?
Let's move this!
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And who had 0 new approvals in 2014? Bayer AG. Think Anavexparin and watch-out!
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The only interim 12-week data presented on Nov 5 was an average +3.21 point increase in the ADSC-ADL score for 14 patients. The rest of the 5-week results were for the full 30pt cohort and revealed an average increase in the MMSE by +1.5 points.
What if the avg increase for the group is +4pt on the MMSE and +7pt on ADSC-ADL after 12 weeks? Placebo effect? The 5 week Cogstate results showed significant improvement in areas where high doses of Donepezil were effective over the 12-week AIBL-ROCS study period, confirming A2-73's synergistic affect and allowing smaller doses of the side-effect-heavy Donepezil. Neuronetrix has a wealth of data to support the use of it's COGNISON system as an FDA-approved EEG/ERP measuring tool, and the PLUS combo showed a dramatic ability to nearly normalize P300 waves in subjects. This will be tracked very closely with the other test data as P300 structure becomes more accepted in the early detection and monitoring of CNSDs.
If the company announces plans to meet with the FDA and seek IRB approval for an A2-73 PLUS P3 in AD this little girl will start to move. That is not going to happen until at least 26 weeks of data from the current trial is available to finalize the design of a P3, likely late this year. If that occurs it will most certainly be accompanied by additional sponsorship in the form of a development/commercialization partnership.
If the 12 and 26 week P2aB data supports the interim results PLUS will be granted BTD going into the next phase, IMO.
"Applying the Breakthrough Therapy Designation Criteria in Practice
In considering a request for BTD, FDA relies on three primary considerations: 1) the quantity and quality of the clinical evidence being submitted in a designation request; 2) the available therapies that the drug is being compared to; and 3) the magnitude of treatment effect shown. Although these considerations are clear, it is difficult to define a single threshold that a therapy must meet in order to receive the designation. Requests for breakthrough therapy designation cover a wide range of therapeutic areas, and although the Expedited Programs guidance recommends that requests be submitted no later than end-of-phase 2, requests may be submitted at different stages of drug development with quite different levels of supporting evidence. Requests can also differ significantly in terms of the amount of clinical trial data included (i.e., differences in sample size, phase of drug development), trial design (i.e., choice of endpoints, single-arm versus, randomized controlled), and trial results (i.e., the magnitude of treatment effect size seen.)"
https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=4&ved=0ahUKEwiR1fzchu_KAhUK1mMKHUqvCXsQFgg3MAM&url=http%3A%2F%2Fwww.fda.gov%2Fdownloads%2FAboutFDA%2FCentersOffices%2FOfficeofMedicalProductsandTobacco%2FCDER%2FUCM447165.pdf&usg=AFQjCNFCD9XgEaOxhitcwbarKxDDLWJ-qw&sig2=6yFFL-0z3YGxOCzbD-5Nnw&cad=rja
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ANAVEX 2-73 and Epilepsy
"Commence double-blinded, randomized, placebo-controlled Phase 2 human trial of ANAVEX 2-73 in additional indication."
This could be a 200pt P2b combo study with Depakene and/or Neurontin as the control, with placebo and A2-73 arms.
I suspect the interest in characterizing the metabolite stems from the revealing of it's acute synergy with the mentioned SOCs.
"ANAVEX 2-73 demonstrated robust synergistic effect in combination with three drugs currently on the market.
With Ethosuximide (ETS) (Zarontin®), a first-generation antiepileptic drug, the combination of 10 mg/kg ANAVEX 2-73 and 200 mg/kg ETS provided 80% protection in MES-induced convulsions, while no protection at all was observed at the same dose of ETS alone. In the (PTZ)-induced convulsion model, the combination of 10 mg/kg ANAVEX 2-73 metabolite and 200 mg/kg of first line anti-epileptic drug Valproic acid (VPA) (Depakene®) showed 92% protection from tonic seizures, compared with modest 12.5% protection when 200 mg/kg VPA was administered on its own. In combination with the newer-generation anti-epileptic drug gabapentin (Neurontin®), ANAVEX 2-73 metabolite also showed a statistically strong effect in the reduction of seizures, compared to gabapentin alone. In the MES test, the combination of 5 mg/kg ANAVEX 2-73 metabolite with 100 mg/kg gabapentin resulted in 90% protection from tonic seizures as compared to 40% protection with 100 mg/kg gabapentin alone."
http://www.anavex.com/?news=anavex-releases-promising-full-preclinical-epilepsy-data-at-antiepileptic-drug-trials-xiii-conference
The AD P2a will provide a suitable safety profile to make the trial duration shorter and efficacy endpoints a primary outcome measure. Drawing parallels between any success of A2-73 as an add-on to Donepezil in AD and the possible outcome of it as an add-on to the SOCs for Epilepsy will be unavoidable. The MOA is identical.
GLTA
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Yes. Most interesting is this $570K from AU gov. This explains the announced intent to commence a P3. A grant from AU to keep the trial based at Caulfield with Dr. Macfarlane. Suppose we will hear more of this grant with a P3 update.
The MJFF grant covers a two year development period. I think we should get an update on the preclinical developments in March.
frrol: If the intervention is successful for the patient they are generally allowed to continue the therapy until the trial terminates, but at their own(or insured) expense. It is part of the informed consent agreement. The 26 week continuation is all the ballyhoo needed for that phase. The announcement of a planned P3 supersedes the need to continue the current P2a. The P2a. participants will be allowed to continue the therapy and statistical monitoring so-long as the drug is under approved CT administration.
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