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SEC Charges Six Firms for Short Selling Violations in Advance of Stock Offerings
In 2014, enforcement actions were brought against 19 firms.
In 2013, enforcement actions were brought against 23 firms.
Lincoln Park, although bashed and drug through the dirt by the uninformed, is not one of those charged.
http://www.sec.gov/news/pressrelease/2015-239.html
There has been no Notice of Effectiveness filed for the recent proposed LP financing. As of now, the financing is only proposed.
Below was filed after the 10/10/13 proposed LP financing -
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Notice of Effectiveness
Effectiveness Date: October 23, 2013 12:00 P.M.
Form: S-1
CIK: 0001314052
Company Name: ANAVEX LIFE SCIENCES CORP.
File Number: 333-191682
My guess is you read this on the internet -
Agree, I'm very pleased with the Lincoln Park financing agreement. AVXL can sell shares to LP at their discretion, at near market price, and there are NO WARRANTS.
Sure, LP will probably immediately sell the shares into the market, but, AVXL can spread out the sales to LP to minimize the impact.
Had a secondary offering been done instead, the price would have been done at ~$1.00 ($4.00 post split) and would have likely included FULL WARRANTS. The shares would have likely been sold into the market after the lock up period and the remaining WARRANTS would have been the source of future selling and dilution.
I still believe that the LP agreement was done primarily to insure access to capital for AVXL while they pursue a partnership to fund their future activities.
All IMHO.
Just a reminder from 2013 -
FDA Wants to Relax Approval Process for Alzheimer's Drugs
Agency points to need for medications that could prevent, slow disease in an aging population
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.
Looks like the FDA wants to approve AD drugs and then confirm their benefits from long term use.
http://consumer.healthday.com/cognitive-and-neurological-health-information-26/alzheimer-s-news-20/fda-wants-to-relax-approval-process-for-alzheimer-s-drugs-674433.html
ANY does a secondary above the market price and you write this -
The full link to MSFT's event -
http://wwmtcstudios.com/en/Events/2016-02-08%20The%20Fastest%20Way%20to%20Containerize%20Your%20Applications%20An%20Interview%20with%20Sphere%203D
Within the text -
Join the session directly by clicking here at 12pm est on 02-08-2016
How does getting above the 50 dma tomorrow benefit AVXL and investors?
We closed at $6.33 on Tuesday. AF bashed AVXL pre-market yesterday and brought the price down for 1 day. Today we closed higher than $6.33.
I'm thinking that people are wise to AF and the other BSers now and their BS will be ignored going forward. Time to start trading on the fundamentals again.
Speaking of fundamentals, AXON has a market cap around 1.7 billion and has an Alz drug that was put on the shelf by GSK due to its ineffectiveness.
AVXL has a miniscule market cap of around 220 million and has an Alz drug that works remarkably well and has a "clean" safety profile -
Positive Safety Data, Statistically Significant Improvements on Exploratory Clinical Endpoints
NEW YORK, NY, November 9, 2015 – Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL). On Saturday, investigators presented positive safety and cognitive efficacy data for ANAVEX 2-73, the Company’s lead investigational oral treatment for Alzheimer’s disease targeting sigma-1 and muscarinic receptors, which are believed to reduce protein misfolding including reduction of beta amyloid, tau protein and inflammation at the international CTAD 2015 conference in Barcelona, Spain.
Initial analysis of Phase 2a data demonstrated that the study met the primary objective of safety as ANAVEX 2-73 was well tolerated and results were consistent with prior Phase 1 clinical trial data. The secondary objectives were also met, with ANAVEX 2-73 showing cognitive improvement across all doses in all exploratory cognitive measurements, including the Cogstate battery, Mini Mental State Examination (MMSE), event-related potentials (ERP) and P300 tests, which consistently demonstrated improvements from baseline in the completed PART A portion of the study in 32 mild-to-moderate Alzheimer’s patients. Even though PART A was designed as a 5 week bioavailability trial that included a built-in wash-out period of 12 days and without an optimized dosing regimen, several Cogstate tests demonstrated highly statistically significant improvements. This finding was supported by a trend towards improvement in median MMSE score, which increased by +1.5 over baseline at week 5.
Positive effects on cognition were further supported by highly statistically significant biomarker effects of treatment at week 5 on one event-related potential (ERP) measure with a p-value of p<0.0007 and improvement in the P300 signal. The ERP biomarker scores improved compared to the initial data presented at AAIC in Washington, DC in July 2015, by which time not all patients had yet completed PART A.
All patients who completed PART A volunteered to continue in the longitudinal PART B extension study.
In the interim analysis of the first 14 patients at week 12, the PART B portion of the study demonstrated a positive trend towards improvement over 12 weeks of ANAVEX 2-73 treatment on the secondary functional outcome measure, the Alzheimer’s Disease Co-operative Study – Activities of Daily Living Inventory (ADCS-ADL) by +3.21 points.
“While it is of prime importance to have confirmed that both the primary and secondary endpoints of the trial have been met, it is extremely encouraging to see the emergence of such strong cognitive signals after only 5 weeks of treatment. Such an outcome in a trial such as this is unprecedented in my experience, and the current results suggest that ANAVEX 2-73 could potentially make a significant difference in patients’ lives,” said Associate Professor Stephen Macfarlane, FRANZCP, Director of Aged Psychiatry at Alfred Health, who conducted the study. “We continue to receive extremely positive feedback about the effects of the drug from our study participants and their caregivers. The results justify a prospective comparison with current standard of care in a larger clinical trial.”
Professor Paul Maruff, Chief Scientific Officer of Cogstate commented: “The Cogstate tests measure people’s ability to store and use information. The results of the Phase 2a study demonstrate that ANAVEX 2-73 improves psychomotor function, attention and working memory. For attention and working memory these improvements were statistically significant with a p-value of p<0.05 and p<0.001, respectively and their magnitude clinically important. To my knowledge, we have not yet seen a drug that has improved quantitatively working memory to such an extent as seen with ANAVEX 2-73”.
Professor Harald Hampel, member of Anavex’s Scientific Advisory Board, and AXA Research Fund Chair at Sorbonne Universities’ Pierre and Marie Curie University (UPMC) in Paris, France, commented: “The collective data from this Phase 2a trial supports the concept of targeting the sigma-1 receptor with ANAVEX 2-73 with a degree of confidence that we did not foresee. Sigma-1 receptor presents an innovative interventional upstream approach to impact key cellular events believed to contribute to Alzheimer’s disease pathophysiology. The presented Phase 2a data underlines the importance of rigorously investigating a potential efficacy signal on co-primary outcomes such as cognition and function in larger and well-powered trials”.
“We are encouraged by the preliminary safety and efficacy data. We look forward to continuing with PART B of the Phase 2a trial and expect to provide data updates at 12 week, 26 week, 38 week and 52 week time points,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. “While we remain focused on Alzheimer’s, the remarkably fast onset of clinical effect of ANAVEX 2-73 increases our options to potentially pursue additional indications for diseases characterized by working memory impairment and may enable clinical trials to be completed within shorter time frames.”
The presentation entitled “New Exploratory Alzheimer’s Drug ANAVEX 2-73: Assessment of Safety and Cognitive Performance in a Phase 2a Study in mild-to-moderate Alzheimer’s Patients” was presented by Professor Steve Macfarlane at CTAD in a late-breaking oral session and is available on the publications page of the Anavex website.
About the ANAVEX 2-73 Phase 2a Study
32 subjects who met NINCDS-ADRDA criteria for probable AD were recruited at five clinical sites in Melbourne, Australia. Subjects are between 55 and 85 years of age, and have a MMSE of 16 to 28. In PART A of the study, participants were administered ANAVEX 2-73 orally and IV in a randomized, open-label, 2-period, cross-over trial separated by a wash-out with adaptive study design lasting up to 36 days (5 weeks) for each participant. In PART B of the study, all participants are administered ANAVEX 2-73 daily orally.
At week 5 the MMSE score increased by +1.5 over baseline. The Cogstate Identification Task, Cogstate One Back Task and ERP Reaction Time all showed statistically significant improvements. In a preliminary interim readout of PART B data, ANAVEX 2-73 improved ADCS-ADL score, a functional measurement, over a period of 12 weeks by +3.21 over baseline, with 11 out of 14 (78.6%) patients improving. Both MMSE and ADCS-ADL are regulatory approved endpoints for pivotal Alzheimer’s disease trials.
The ongoing, multicenter Phase 2a adaptive trial of ANAVEX 2-73 in both male and female mild-to-moderate Alzheimer’s patients enrolled 32 participants. It commenced in January 2015 and the participants, the majority of whom are also taking donepezil, have now completed PART A of the two-part trial. Lasting up to 36 days (5 weeks) for each patient, PART A was a simple randomized, open-label, two-period trial with an on-off-on not-yet-optimized dosing regimen to assess bioavailability, and cross-over between oral (30mg/50mg) and IV (3mg/5mg) administration. Event-related potentials (ERP) were used to assess cognitive effects and optimize dosing of ANAVEX 2-73. PART B is an open-label extension for a further 52 weeks. Initially planned for 26 weeks, PART B was extended to 52 weeks as a result of requests from patients and caregivers. PART B utilizes daily oral dosing in order to establish a longer drug effect.
The primary endpoint of the Phase 2a trial is evaluation of safety and tolerability of ANAVEX 2-73, which had shown potential in preclinical studies to prevent, halt and/or reverse the course of the disease. Secondary endpoints were dose response, bioavailability, and exploratory cognitive effects using electroencephalographic (EEG) activity and event-related potentials (ERP), Cogstate battery, Mini Mental State Examination (MMSE), and evaluation of Alzheimer’s Disease Co-operative Study – Activities of Daily Living Inventory (ADSC-ADL) as well as the exploration of ANAVEX 2-73 as a potential add-on therapy to donepezil, the current standard of care. The combination of ANAVEX 2-73 and donepezil (Aricept®) is known as ANAVEX PLUS.
AVXL is in an enviable position after completing preclinical lab work. This allows for a low headcount and low cash burn rate.
This from IR -
The Anavex laboratory was very active from the company’s inception in 2007 until a few years ago. The task of developing several promising compounds has been accomplished, one of which (ANAVEX 2-73) is now in a Phase 2a clinical trial. In the meantime, Anavex also in-licensed another promising compound, ANAVEX 3-71 (formerly AF710B), from a lab of the Weizmann Institute. The company’s focus has now shifted towards clinical development, which cannot be performed in the lab.
AVXL is a lean powerhouse.
Thank You Dr. Missling for the brilliant leadership!!!
Read this and at least hope for the best for Alzheimer's Disease patients -
http://www.anavex.com/?news=anavex-confirms-data-for-phase-2a-alzheimers-trial-for-anavex-2-73
You don't know?
Yes, the FDA is not paying for the trial. AVXL is simply following the FDA guidelines.
The trial is following FDA guidelines. This is as involved as he FDA gets.
The key is to understand the difference between a statistical standard trial, which is based on the placebo versus active dose in a number of patients, and the adaptive trial design statistical method used. The FDA has written a very eloquent guideline which you can find on the fda.gov website (http://www.fda.gov/downloads/Drugs/Guidances/ucm201790.pdf). The FDA states that with the adaptive trial design, which we are using, you need fewer patients, you are able to do this in a shorter period of time, you are more likely to demonstrate the effect of the drug, and you are getting more information on the treatment effect as well as a better understanding of dose response information in subgroups. Lastly, you are able to identify and optimize the parameters needed for Phase 3 effects. So, this Phase 2a trial is a very important stepping stone and building block for a successful Phase 3 trial. We want to avoid the same failure that the other Alzheimer drug trials experienced, and by implementing a different, innovative trial design for ANAVEX-73 in Alzheimer’s treatment, we are leading a more efficient study than a conventional study.
Yes, there are doctors out there that are not pretend doctors.
Here is an interview with the AVXL trial's principal investigator.
To me, it was extremely encouraging to see any sign of a cognitive signal in a five-week study, and the strength of these signals was remarkable. I've been running Alzheimer's trials for over 16 years, and have never seen such a strong cognitive signal in any of the trials I've been involved in (including solanezumab).
The study was not powered to demonstrate significance, but the response on certain outcome measures was so marked that significance was achieved anyway (at a level of p=0.001 in the case of the Cogitate one-back task.
A similar outcome in a trial such as this is unprecedented in my experience. I'd cite again the fact size of 1.1 for ANAVEX 2-73 on the Cogstate One-back test, and compare this to the published metaanalysis of donepezil's effect on the same test (0.28). Bear in mind, once again, that 75% of our subjects were already on a stable dose of donepezil for at least 3 months prior to baseline.
http://seekingalpha.com/article/3672856-anavex-life-sciences-interview-with-dr-stephen-macfarlane
A2-73 has an excellent safety profile and it's benefits to the patients has been remarkable!!!
A fake Dr. would call AVXL a scam.
This from Dr. that is not a fake Dr. -
Professor Paul Maruff, Chief Scientific Officer of Cogstate commented: “The Cogstate tests measure people’s ability to store and use information. The results of the Phase 2a study demonstrate that ANAVEX 2-73 improves psychomotor function, attention and working memory. For attention and working memory these improvements were statistically significant with a p-value of p<0.05 and p<0.001, respectively and their magnitude clinically important. To my knowledge, we have not yet seen a drug that has improved quantitatively working memory to such an extent as seen with ANAVEX 2-73”.
This from a real Dr. -
Professor Harald Hampel, member of Anavex’s Scientific Advisory Board, and AXA Research Fund Chair at Sorbonne Universities’ Pierre and Marie Curie University (UPMC) in Paris, France, commented: “The collective data from this Phase 2a trial supports the concept of targeting the sigma-1 receptor with ANAVEX 2-73 with a degree of confidence that we did not foresee. Sigma-1 receptor presents an innovative interventional upstream approach to impact key cellular events believed to contribute to Alzheimer’s disease pathophysiology. The presented Phase 2a data underlines the importance of rigorously investigating a potential efficacy signal on co-primary outcomes such as cognition and function in larger and well-powered trials”.
AVXL basically stalled in neutral, after completing a 2-73 Phase 1 trial in 2011, until Dr. Missling was hired as CEO in July, 2013.
Dr. Missling was able to raise capital (previous CEOs failed to do this), pushed 2-73 through another Phase 1 trial and half way through a Phase 2a trial in a little over 2 years. Unheard of in baby biotech land.
It wouldn't surprise me if AVXL has a partner and has started the next trial phase before Phase 2a, Part B is completed.
I will defend Dr. Missling all the way to the bank!!!
Good post -
Some share holders don't realize that AVXL would not have been in a position to run trials if it weren't for CEO Missling. The article below gives background on his fund raising efforts and more.
http://lifescienceleadermag.epubxp.com/i/547536-aug-2015/47
Give us a list of candidates that are more qualified than Missling to run AVXL.
None of the CEOs of the other biotechs that I am familiar with are any where close to being as qualified.
I'm very thankful for this -
"Anavex 2-73 Reverses Cognitive Deficits Measured by Standard ERP Methods at week 5"
Baseline - 5.99
Week 5 - 7.09
Healthy Control - 7.36
https://pbs.twimg.com/media/CTMsjZYWcAAZ6J5.jpg:large
REVERSES COGNITIVE DEFICITS in 5 weeks!!!
This is epic!!!
Happy Thanksgiving!!!
Here's to all afflicted with Alzheimer's Disease being in a position to be thankful for A2-73 Plus in a couple of years.
Good post from another board with some info on Aricept, the Standard of Care for Alz -
The FDA also reported that the slight decrease in *regression* that DZP showed in ACDS-ADL was insignificant to patients daily living and reiterated that the patients STILL regressed in ADL on Aricept. To my knowledge ACDS-ADL is also one of TWO metrics that the FDA is most interested in (since it is a functional assessment of the users actual daily living capabilities) so I am quite sure their ears perked up on the amazing results that Avanex showed in their early stage Phase 2A Part B study. Believe you me the *FDA* didn't look at the results like AF/JF/Bashers did and say 'insignificant' or 'meaningless' and understood clearly the implications if those results continue AND how rare / non-existent results like that have been in years and years of studies by other drugs.
Sentiment: Strong Buy
DD - Updated Collection Of Recent Articles And Videos With The Most Recent First:
Go to Anavex.com for press releases and more info on the Company
Point-by-point rebuttal to Fonteneau's attack article.
https://medium.com/@jdlambert/the-anavex-story-for-honest-investors-67e1238d4238
http://www.anavex.com/files/Anavex_Presentation_Fall_2015+.pdf
ANAVEX™ 2--73 Increases P300 Amplitude Earlier and 4x Higher than Donepezil
ANAVEX™ 2--73 Improves both Accuracy and Reaction Time in the Target Detection Task of the ERP Test
http://seekingalpha.com/article/3672856-anavex-life-sciences-interview-with-dr-stephen-macfarlane
Five out of the 6 cogstate domains showed improvement, with 3 of these showing large effect sizes. The 'one-back' test within cogitate showed an effect size of 1.1 (meaning the standard distribution curve of the results was improved by 1.1 standard deviations, a huge effect size. A published meta-analysis of donepezil's benefit on the same test showed an effect size of 0.28. The significance of this particular change is underlined by the fact that 75% of our sample had already been taking a stable dose of donepezil for at least three months, so the improvements on the Cogitate battery (and on all the other cognitive outcome measures, were achieved over and above the gains our participants might already have achieved through being on donepezil. The same is true for the improvements noted on MMSE and ADCS-ADL, and the EEG markers (of which one ERP was statistically significant). I gather much is being made in certain circles that the remainder of the EEG markers, as well as the MMSE and ADCS-ADL scores failed to achieve statistical significance, but in a 5-week study of 32 patients it would almost have been beyond belief if this were to have been shown to be the case. The study was not powered to demonstrate significance, but the response on certain outcome measures was so marked that significance was achieved anyway (at a level of p=0.001 in the case of the Cogitate one-back task.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=118144632
Nice Anavex summary
http://seekingalpha.com/article/3444196-premarket-biotech-digest-axovant-analysis-anavex-gets-grant-pharmacyclis-imbruvica?auth_param=btpbb:1at3j0l:afa85ef47d3b60d78c9840325c93132b&uprof=45
I initiated coverage on AVXL almost a month ago. In the article, I had noted that AVXL appears to be the most interesting Alzheimer's disease ("AD") drug company with the lowest valuation. The potential of the company's lead product candidate, Anavex 2-73, was reconfirmed when it released initial data from a Phase 2a study last month. The data showed early evidence of improving condition in patients with AD.
In AD alone, AVXL has a fair value of $5 per share, after adjusting for risk. If you add the potential in Parkinson's, then the potential value of the stock is even higher. If AVXL's concept is proven in AD, it is very likely that it will be proven in Parkinson's as well. (Note: The $5.00 price target was before the 1 for 4 reverse split. It equates to a $20.00 price target now.)
http://www.marketwatch.com/story/anavex-receives-notice-of-allowance-for-us-patent-application-related-to-anavex-2-73-2015-08-12
NEW YORK, Aug 12, 2015 (GLOBE NEWSWIRE via COMTEX) --
Anavex Life Sciences Corp. ("Anavex" or the "Company") (otcqx:AVXL), a clinical-stage biopharmaceutical company developing drug candidates to treat Alzheimer's disease, other central nervous system (CNS) diseases, pain, and various types of cancer, today announced that it has received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for U.S. Pat. App. No. 14/205,637 related to ANAVEX 2-73. Upon issuance, the patent will provide intellectual property (IP) protection until at least 2035. ANAVEX2-73 is the subject of an ongoing Phase 2a clinical trial for the treatment of Alzheimer's disease.
https://www.michaeljfox.org/foundation/grant-detail.php?grant_id=1450
Impact on Diagnosis/Treatment of Parkinson’s:
The present study holds potential to impact the way Parkinson’s disease is treated. We aim to develop a new pharmacological approach to boost repair mechanisms and dampen inflammation in the part of the brain that is most affected by Parkinson’s. If this treatment exerts the expected effects, it could slow the progression of the disease.
Next Steps for Development:
If successful, this study will accelerate the translation of pre-clinical findings into the first clinical trial of ANAVEX2-73 as a potential disease-modifying therapy for Parkinson’s disease. ANAVEX2-73 has already been tested for safety and tolerability in humans with positive results.
http://seekingalpha.com/article/3354415-interview-with-dr-christopher-missling-ceo-of-anavex?auth_param=d2ta:1ar4d6c:74ced639ac1ecb22d9cbea5192bcfa90
KKD - So, until you get the patent assigned to you, you cannot begin the Anavex Plus trial, correct?
CM - No. All patents are irrevocably assigned or owned by Anavex.
http://seekingalpha.com/article/3354385-anavex-may-actually-cure-alzheimers
https://au.news.yahoo.com/video/watch/29015798/new-pills-offer-hope-for-alzheimers-sufferers/#page1
"It's like being in the dark and someone switched the light on."
http://www.heraldsun.com.au/news/victorians-first-to-trial-breakthrough-brain-booster-pill/story-fni0fiyv-1227453139615
A PILL to treat Alzheimer’s disease is four times more effective than the current treatment in boosting the brain power of patients.
“We’ve also had patients and their carers reporting improvements in their thinking, increased alertness and improvement in their organisation and independence,” Prof Macfarlane said.
http://thestockradio.com/otcqx-avxl-anavex-life-sciences-corp-ceo-pres-christopher-missling-2050.html
http://www.anavex.com/
Corporate Presentation - Spring 2015
http://www.endevr.com/dementia/New-drug-might-help-prevent-slow-or-reverse-Alzheimer-s
Findings in a recent peer-reviewed scientific journal reveals that our lead drug, ANAVEX 2-73 has the potential to prevent, stop, slow or reverse the disease, in addition to treating its symptoms.
CEO Missling says the number of patients for a pivotal Phase 3 trial could range anywhere from 100 to 300.
Excellent rebuttal to that hit piece here -
http://www.investorvillage.com/smbd.asp?mb=9414&mn=262&pt=msg&mid=15460115
CEO Missling seems to prefer the "late breaking" path into conferences. If he plans to present at the Biotech Showcase, we may not know about it until after the sign-up deadline.
Data has been excellent and AVXL has more data that has not been released. Missling, Macfarlane and the other experts quoted in the last data PR are very upbeat.
AVXL will get a much better partnership deal and higher priced offering(if needed) after more trial results.
I don't expect a partnership or offering for at least 6 months.
Any future trials will take time to set up and AVXL doesn't need the money in the interim.
Most of the bears like to harp on the placebo effect. I am very pleased that Dr. Stephen Macfarlane addressed the placebo effect in this interview -
4. Of all the battery of tests which do you think most powerful for AD, and how did Anavex 2-73 perform in that test?
The One-back test (which measures working memory, a key domain of impairment in AD) within the Cogstate battery is the most difficult test, yet showed the greatest improvement. This outcome is unlikely to have been an artefact of any placebo effect...when placebo effects occur they are typically larger for the easier tests. In addition, whilst placebo effects are common with CNS sedative drugs, they are less likely to be present in tests of drugs used to enhance cognition...individuals cannot anticipate, or 'imagine' what a better score would consist of, and are unable to produce improved results through mere 'wishful thinking.'
http://seekingalpha.com/article/3672856-anavex-life-sciences-interview-with-dr-stephen-macfarlane
Ignore the day to day share price. Patience is needed for the big pay off.
Buy - Hold - Get Rich
SIMPLE!!!
There has been no dumping. A poster here checks with the transfer agent weekly.
As of now AVXL COULD sell shares to LPC but hasn't.
As of now AVXL has filed a $100,000,000 shelf for a possible future offering(s).
There are fewer than 9 million warrants left outstanding.
A Form 4 must be filed before the end of the second business day following a change in ownership of securities or derivative securities (including the exercise or grant of stock options) for individuals subject to Section 16 of the Securities Exchange Act of 1934.
https://en.wikipedia.org/wiki/Form_4
Yup, here is the interview with the AVXL trial's principal investigator.
To me, it was extremely encouraging to see any sign of a cognitive signal in a five-week study, and the strength of these signals was remarkable. I've been running Alzheimer's trials for over 16 years, and have never seen such a strong cognitive signal in any of the trials I've been involved in (including solanezumab).
The study was not powered to demonstrate significance, but the response on certain outcome measures was so marked that significance was achieved anyway (at a level of p=0.001 in the case of the Cogitate one-back task.
A similar outcome in a trial such as this is unprecedented in my experience. I'd cite again the fact size of 1.1 for ANAVEX 2-73 on the Cogstate One-back test, and compare this to the published metaanalysis of donepezil's effect on the same test (0.28). Bear in mind, once again, that 75% of our subjects were already on a stable dose of donepezil for at least 3 months prior to baseline.
http://seekingalpha.com/article/3672856-anavex-life-sciences-interview-with-dr-stephen-macfarlane
A2-73 has an excellent safety profile and it's benefits to the patients has been remarkable!!!
The grant covers the entire cost of the A2-73 Parkinson's pre-clinical trial.
Excellent!!!
You're concerned that some trader operation, that nobodies heard of, highlights AVXL? That's laughable!
While at the same time you're not concerned by the major untruthful, coordinated short attack from the likes of Street Sweeper, SA, AF and many others? That's criminal!
AVXL has not paid to have its stock promoted.
Period!!!
DD - Updated Collection Of Recent Articles And Videos With The Most Recent First:
Go to Anavex.com for press releases and more info on the Company
http://www.anavex.com/files/Anavex_Presentation_Fall_2015+.pdf
ANAVEX™ 2--73 Increases P300 Amplitude Earlier and 4x Higher than Donepezil
ANAVEX™ 2--73 Improves both Accuracy and Reaction Time in the Target Detection Task of the ERP Test
http://seekingalpha.com/article/3672856-anavex-life-sciences-interview-with-dr-stephen-macfarlane
Five out of the 6 cogstate domains showed improvement, with 3 of these showing large effect sizes. The 'one-back' test within cogitate showed an effect size of 1.1 (meaning the standard distribution curve of the results was improved by 1.1 standard deviations, a huge effect size. A published meta-analysis of donepezil's benefit on the same test showed an effect size of 0.28. The significance of this particular change is underlined by the fact that 75% of our sample had already been taking a stable dose of donepezil for at least three months, so the improvements on the Cogitate battery (and on all the other cognitive outcome measures, were achieved over and above the gains our participants might already have achieved through being on donepezil. The same is true for the improvements noted on MMSE and ADCS-ADL, and the EEG markers (of which one ERP was statistically significant). I gather much is being made in certain circles that the remainder of the EEG markers, as well as the MMSE and ADCS-ADL scores failed to achieve statistical significance, but in a 5-week study of 32 patients it would almost have been beyond belief if this were to have been shown to be the case. The study was not powered to demonstrate significance, but the response on certain outcome measures was so marked that significance was achieved anyway (at a level of p=0.001 in the case of the Cogitate one-back task.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=118144632
Nice Anavex summary
http://seekingalpha.com/article/3444196-premarket-biotech-digest-axovant-analysis-anavex-gets-grant-pharmacyclis-imbruvica?auth_param=btpbb:1at3j0l:afa85ef47d3b60d78c9840325c93132b&uprof=45
I initiated coverage on AVXL almost a month ago. In the article, I had noted that AVXL appears to be the most interesting Alzheimer's disease ("AD") drug company with the lowest valuation. The potential of the company's lead product candidate, Anavex 2-73, was reconfirmed when it released initial data from a Phase 2a study last month. The data showed early evidence of improving condition in patients with AD.
In AD alone, AVXL has a fair value of $5 per share, after adjusting for risk. If you add the potential in Parkinson's, then the potential value of the stock is even higher. If AVXL's concept is proven in AD, it is very likely that it will be proven in Parkinson's as well.
http://www.marketwatch.com/story/anavex-receives-notice-of-allowance-for-us-patent-application-related-to-anavex-2-73-2015-08-12
NEW YORK, Aug 12, 2015 (GLOBE NEWSWIRE via COMTEX) --
Anavex Life Sciences Corp. ("Anavex" or the "Company") (otcqx:AVXL), a clinical-stage biopharmaceutical company developing drug candidates to treat Alzheimer's disease, other central nervous system (CNS) diseases, pain, and various types of cancer, today announced that it has received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for U.S. Pat. App. No. 14/205,637 related to ANAVEX 2-73. Upon issuance, the patent will provide intellectual property (IP) protection until at least 2035. ANAVEX2-73 is the subject of an ongoing Phase 2a clinical trial for the treatment of Alzheimer's disease.
https://www.michaeljfox.org/foundation/grant-detail.php?grant_id=1450
Impact on Diagnosis/Treatment of Parkinson’s:
The present study holds potential to impact the way Parkinson’s disease is treated. We aim to develop a new pharmacological approach to boost repair mechanisms and dampen inflammation in the part of the brain that is most affected by Parkinson’s. If this treatment exerts the expected effects, it could slow the progression of the disease.
Next Steps for Development:
If successful, this study will accelerate the translation of pre-clinical findings into the first clinical trial of ANAVEX2-73 as a potential disease-modifying therapy for Parkinson’s disease. ANAVEX2-73 has already been tested for safety and tolerability in humans with positive results.
http://seekingalpha.com/article/3354415-interview-with-dr-christopher-missling-ceo-of-anavex?auth_param=d2ta:1ar4d6c:74ced639ac1ecb22d9cbea5192bcfa90
KKD - So, until you get the patent assigned to you, you cannot begin the Anavex Plus trial, correct?
CM - No. All patents are irrevocably assigned or owned by Anavex.
http://seekingalpha.com/article/3354385-anavex-may-actually-cure-alzheimers
https://au.news.yahoo.com/video/watch/29015798/new-pills-offer-hope-for-alzheimers-sufferers/#page1
"It's like being in the dark and someone switched the light on."
http://www.heraldsun.com.au/news/victorians-first-to-trial-breakthrough-brain-booster-pill/story-fni0fiyv-1227453139615
A PILL to treat Alzheimer’s disease is four times more effective than the current treatment in boosting the brain power of patients.
“We’ve also had patients and their carers reporting improvements in their thinking, increased alertness and improvement in their organisation and independence,” Prof Macfarlane said.
http://thestockradio.com/otcqx-avxl-anavex-life-sciences-corp-ceo-pres-christopher-missling-2050.html
http://www.anavex.com/
Corporate Presentation - Spring 2015
http://www.endevr.com/dementia/New-drug-might-help-prevent-slow-or-reverse-Alzheimer-s
Findings in a recent peer-reviewed scientific journal reveals that our lead drug, ANAVEX 2-73 has the potential to prevent, stop, slow or reverse the disease, in addition to treating its symptoms.