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Maybe, but, WI is off-topic.
Check for my previous post. Doesn't take long.
Any idea of how many patients "demonstrated impressive activity"?
SAN ANTONIO, TX--(Marketwired - Sep 9, 2015) - GenSpera, Inc. (OTCQB: GNSZ) today announced that interim data from its Phase II study of mipsagargin (G-202) in adult patients with recurrent or progressive glioblastoma has demonstrated impressive activity in patients to date. The two-stage, single-arm, open-label study (NCT02067156) is led by David Piccioni, M.D., Ph.D. and Santosh Kesari, M.D., Ph.D. at the UC San Diego Moores Cancer Center in La Jolla, CA.
GM AVXLers, I hope everyone had a great holiday weekend.
Good post by me2yousee on Yahoo -
Patients and their families asking / begging to stay on a drug says it all. The rest is just paperwork.
Added 8K at a buck
Focus Ticker: Anavex Life Sciences
As I noted above, it is about what individual companies are doing in the biotech sector that matters. And Anavex Life Sciences (OTCQX:AVXL) is an excellent example. Last month as the sector struggled, AVXL shares actually gained nearly 50%. All of the gains were driven by the promise of the company's lead product candidate in Alzheimer's disease.
What is the reason to be excited about Anavex? It is the science behind the lead product candidate, Anavex 2-73. Alzheimer's disease affects millions globally. The Alzheimer's treatment market is worth billions of dollars. And yet there is still a significant unmet need in this area. The reason is the lack of understanding of how the brain works. In a recent whitepaper, the FDA noted that amyloid beta plaque reduction does not seem to have made any inroads against Alzheimer's.
But what Anavex is doing holds a great deal of promise for the millions suffering from the dreaded disease. Amyloid plaque buildup is caused by misfolded protein. While amyloid plaque reduction is important, it is also important to fold back misfolded proteins in order to stop them from creating additional plaque buildup. Anavex 2-73 is an agonist of sigma-1r, which is a chaperone protein that helps a protein achieve its properly folded form. Anavex 2-73 increases this chaperone protein's action which then resolves protein misfolding. When combined with donapezil, which reduces already created misfolded protein conglomers, Anavex 2-73 holds tremendous potential. And this is why AVXL is one of the most talked about companies in Alzheimer's space.
http://seekingalpha.com/article/3490336-premarket-biotech-digest-shorts-targeting-biotech-anavexs-promise-zarxio-launch
Wow, only 250,000 available to short at IB. Last Saturday there were 3.8 million available to short. Guess we know why we dropped this week. I'd rather see shorting cause the dip instead of selling. The shorts will buy to cover at some point -
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=116606349
The first Phase 2A trial patient was dosed on January 12th. This patient should have completed the 26 weeks maximum by July 12th. Quite a few other patients probably completed 3 months or more before the July 22nd data release date.
Closed up 3 trading days ago, on 8/31.
Anavex 2-73 works. Of that I have no doubt -
I have never before seen anything close to the following in a trial data release.
“This is the first time the investigational drug ANAVEX 2-73 has been administered to Alzheimer’s patients. In addition to the positive EEG/ERP P300 biomarker signal, the feedback we’ve had so far is that patients and care providers have noticed both cognitive and functional improvement, increased alertness, improvement in activities of daily living, greater organization and a requirement for less prompting,” said study’s principal investigator Dr. Stephen Macfarlane, FRANZCP, Associate Professor and Director of Aged Psychiatry at The Alfred Hospital. “Subsequent to the positive initial feedback, we are applying to expand the extension period from 26 weeks to 52 weeks at the request of the participants.”
No, Anavex and Anavex 2-73 will succeed and I have placed my bet accordingly.
We know that 2-73 works. It's initial Phase 2 results were astonishing and the dosing hasn't even been optimized yet.
What we don't know, yet -
1) how much better 2-73 will work once optimized
2) will 2-73 be effective in 100% of patients once optimized
3) how well 2-73 will work over a longer time span
4) will a safety issue pop up after longer term use
3) Initially at 300% better than Standard of Care donepezil (without optimization), 2-73 has a huge cushion of effectiveness. If for some reason 2-73's results waned by 50% over a longer time span, it would still outperform donepezil by 100%.
Keep in mind that donepezil is only effective in 1/3 of patients and only works for 1 year (from what I've heard).
4) From safety trial - "Additionally, no sign could be detected for any dose- or time-dependent changes for any of the hematology, biochemistry, and coagulation parameters."
Safety: No serious side effects were reported. There was no study discontinuation due to adverse events. No dose-limiting adverse events or lab abnormalities at doses of 1, 10, 30, 40 and 50mg were observed.
Tolerability: Maximum tolerated dose (MTD) of ANAVEX 2-73 was defined as 55mg. Observed adverse events at doses above the MTD included dizziness and headache, which were moderate in severity and reversible. These side effects are often seen with drugs that target CNS conditions, including Alzheimer’s disease. Across all doses, there were no differences in blood pressure and resting heart rate. Analysis of electrocardiograms (ECG) did not reveal any dose-related or time-dependent changes and the QT interval did not reveal any clinically significant changes. Additionally, no sign could be detected for any dose- or time-dependent changes for any of the hematology, biochemistry, and coagulation parameters.
Pharmacokinetics (PK): ANAVEX 2-73 was determined to be suitable for daily oral dosing based on its PK profile. PK data revealed biotransformation of ANAVEX 2-73 to its main metabolite, which also actively targets sigma-1 and muscarinic receptors like its parent drug ANAVEX 2-73. Both maximum plasma concentration (Cmax), which relates to absorption and distribution of the drug in the blood, and area under the plasma concentration-time curve (AUC), which represents the total drug exposure over time, showed dose-proportional linear increases for both ANAVEX 2-73 and its metabolite. The biological half-life (T1/2) for ANAVEX 2-73 was 8.56 hours and 28.74 hours for its metabolite.
http://www.anavex.com/?news=anavex-announces-positive-phase-1-data-for-anavex-2-73-lead-candidate-for-the-treatment-of-alzheimers
Three reasons why Anavex will succeed -
1) NEW YORK, NY, July 22, 2015 – Anavex Life Sciences Corp. (“Anavex” or the “Company”) (OTCQX: AVXL) today announced initial positive cognitive data for ANAVEX 2-73, the Company’s lead investigational oral treatment for Alzheimer’s targeting sigma-1 and muscarinic receptors, which is believed to reduce protein misfolding including reduction of beta amyloid, tau and inflammation. Cognitive EEG/ERP P300 data, a real-time physiological measure of cognitive processes with demonstrated sensitivity to Alzheimer’s disease, is being presented today for the first 12 of 32 mild-to-moderate Alzheimer’s patients in the ongoing ANAVEX 2-73 Phase 2a clinical trial at AAIC 2015 in Washington, DC.
ANAVEX 2-73 showed in 83 percent (10/12) of patients positive cognitive effects during PART A of the study, which consists of a 36-day on-off-on not-yet-optimized dosing regimen to assess bioavailability. At day 36, the amplitude of the cognitive EEG/ERP biomarker P300 increased 38 percent from baseline. Published data suggests that a 38 percent increase is approximately 4 times higher than donepezil (Aricept®), the current standard of care, in the same timeframe.
Preliminary measured Mini Mental State Examination (MMSE) and Cogstate scale changes are consistent with the observed trend of the cognitive EEG/ERP effect. The safety profile of ANAVEX 2-73 during Phase 2a appears consistent with the Phase 1 data; additional clinical data of the trial will be presented at future medical meetings.
“This is the first time the investigational drug ANAVEX 2-73 has been administered to Alzheimer’s patients. In addition to the positive EEG/ERP P300 biomarker signal, the feedback we’ve had so far is that patients and care providers have noticed both cognitive and functional improvement, increased alertness, improvement in activities of daily living, greater organization and a requirement for less prompting,” said study’s principal investigator Dr. Stephen Macfarlane, FRANZCP, Associate Professor and Director of Aged Psychiatry at The Alfred Hospital. “Subsequent to the positive initial feedback, we are applying to expand the extension period from 26 weeks to 52 weeks at the request of the participants.”
“We are cautiously optimistic given the encouraging feedback and the preliminary cognitive data. We look forward to the full ANAVEX 2-73 Phase 2a trial results,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. “As of today, we have enrolled two-thirds of the patients. We expect the trial to be fully enrolled and to have PART A completed by the end of the year.”
2) New York, NY — March 27, 2014 — Anavex Life Sciences Corp. (“Anavex” or the “Company”) (OTCQB: AVXL), a clinical stage biopharmaceutical company developing novel drug candidates to treat Alzheimer’s, diseases of the central nervous system (CNS) and various types of cancer, today announced that a report in the current issue of peer-reviewed International Pharmaceutical Industry Journal (“IPI Journal”) predicts that ANAVEX 2-73 will have a meaningful effect in Alzheimer’s disease based on the Alzheimer’s Disease Assessment Scale-Cognitive (“ADAS-Cog”), especially when combined with donepezil (Aricept®), the world’s best-selling Alzheimer’s drug. The Company believes this drug combination, called ANAVEX PLUS, is a compelling commercial opportunity because of its potential to treat symptoms of Alzheimer’s while also possibly modifying or reversing the course of the disease. A Phase 1b/2a clinical trial of ANAVEX PLUS, is scheduled to begin mid 2014.
The findings, utilizing a predictive humanized calibrated cortical cognitive model for Alzheimer’s Disease in, which was focusing on symptomatic effects based on the M2 antagonistic target engagement level of ANAVEX 2-73, predict that ANAVEX PLUS, combining ANAVEX 2-73 with low dose (5mg) donepezil (Aricept®), will show a significantly improved clinical outcome versus when the drugs are administered individually. ANAVEX PLUS is expected to show up to 9 points improvement in ADAS-Cog at 12 weeks and 6 points at 26 weeks in mild-to-moderate Alzheimer’s patients, respectively, at target engagement levels of approximately 70%. When administered alone, ANAVEX 2-73 is expected to improve ADAS-Cog by 5 points at 12 weeks, and 3 point at 26 weeks, which is also likely to be detected clinically. As a point of reference, in human clinical trials 5 mg donepezil (Aricept®) was reported to show an average improvement of 3.6 points ADAS-Cog at 12 weeks and 2.6 at 26 weeks, respectively.
“This data, as reported in IPI Journal, confirms the strong synergy we have previously seen preclinically between ANAVEX 2-73 and donepezil. It also supports the advancement of ANAVEX PLUS into a Phase 1b/2a trial,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. “The same type of computer model is in use by big pharmaceutical companies to predict the difference between rodent and human brains as well as the anticipated clinical trial outcome. Therefore, the computer simulation model is believed to have reduced the trial risk for ANAVEX PLUS.”
The report, entitled “The Anticipated Clinical Effect of the new Alzheimer Drug ANAVEX PLUS in a Predictive Humanized Cortical Cognitive Model for Alzheimer’s Disease,” was co-authored by Drs. Missling, Maurice and Geerts, Chief Scientific Officer of In Silico BioSciences (ISB) and Adjunct Professor at the School of Medicine at the University of Pennsylvania, along with industry colleagues.
3) Study Presented at CNS Summit 2013 Suggests ANAVEX 2-73 Will Have Clinically Detectable and Meaningful Effect in Alzheimer’s Disease, Especially When Combined With Aricept®
New York, NY — November 18, 2013 — Anavex Life Sciences Corp. (“Anavex” or the “Company”) (OTCQB: AVXL) presented new data from a study evaluating ANAVEX 2-73 in a computer simulation model of Alzheimer’s disease (AD) limited to symptomatic effects, which was presented during a poster session at the CNS Summit 2013 on Saturday, November 16th, 2013 in Boca Raton, Florida.
The results from the poster, entitled, “The anticipated clinical effect of the new Alzheimer drug ANAVEX 2-73 in a calibrated Quantitative Systems Pharmacology Platform”, predict that ANAVEX 2-73, in a realistic cortical network computer model of AD, will show a clinical dose-dependent improvement in AD Assessment Scale – Cognitive (ADAS-Cog) of 2-3 points at 12 weeks, which is similar to Aricept® (donepezil), currently the best-selling Alzheimer’s drug with reported sales of $4 billion last year. However, when combining ANAVEX 2-73 with low dose (5mg) Aricept® (donepezil), the clinical outcome significantly improves, to a maximal effect of anticipated ADAS-Cog response of 6-7 points at 12 weeks and 4.5-5.5 points at 26 weeks in mild-to-moderate AD patients, respectively. These improvements suggest the effects will likely be clinically detectable and meaningful.
Tangui Maurice, PhD, CNRS Research Director at the University of Montpellier and INSERM, said, “This data confirms the significant and unexpected synergy we have previously seen between ANAVEX 2-73 and Aricept® (donepezil) in a preclinical model. This result allows us to confidently move forward into the analysis of this potentially promising combination drug for Alzheimer’s disease. ”
Hugo Geerts, PhD, Chief Scientific Officer of In Silico BioSciences (ISB) and Adjunct Professor at the School of Medicine at the University of Pennsylvania, stated, “We don’t have many examples of blinded predictions using our Quantitative Systems Pharmacology platform, only three so far, however, in those three cases the respective sponsor performed a clinical trial that essentially confirmed our unexpected quantitative predictions, and the respective outcomes were published.”
Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex, said, “The data is quite encouraging since the study focused purely on symptomatic effects and no sigma-1 effect was implemented or considered. With this study we added another layer of positive evidence to advance ANAVEX 2-73 in combination with donepezil into clinical trials.”
The poster was co-authored by Dr. Maurice and Dr. Geerts, as well as Athan Spiros, PhD, Chief Technology Officer at ISB; and Patrick Roberts, PhD, Director of Computational Systems Pharmacology at ISB and Adjunct Professor in Biomedical Engineering at Oregon Health & Science University and Systems Science Program at Portland State University.
Bottoming zone 1.20 - 1.25
AVXL is ridiculously cheap now -
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://seekingalpha.com/article/3470716-why-anavex-is-leading-the-race-against-other-pharma-to-help-alzheimers-patients?auth_param=d2ta:1au0jgg:fb5ea77f76cef3132ca37e80258df0e7
Thank You apollo1452,
AVXL dedicated a full page, from their latest presentation, to their Execution Plan -
ANAVEX 2-73 / ANAVEX PLUS Efficient Clinical Trial Execution Plan
ANAVEX2-73-001 Study: • Phase 1 (oral) • Single Ascending Dose (SAD) • Healthy subjects
Completed
ANAVEX2-73-002 Study: • Phase 2a (oral) • Mild-to-moderate AD patients • Adaptive trial with Population PK • Bioavailability, dose finding, and exploratory efficacy with 6-month open-label extension
Underway – Preliminary Data: Q3 2015
ANAVEX2-73-00X Study: • Phase 3 (oral) • Mild-to-moderate AD patients • 6/12 month efficacy
Start after Phase 2a
http://www.anavex.com/files/Anavex_Presentation_May_2015.pdf
No, the article says foundation. The presentation shows directly from Phase 2A to Phase 3 -
From AVXL's most recent presentation. Page 20 -
http://www.anavex.com/files/Anavex_Presentation_May_2015.pdf
ANAVEX 2-73 / ANAVEX PLUS Efficient Clinical Trial Execution Plan
ANAVEX2-73-001 Study: • Phase 1 (oral) • Single Ascending Dose (SAD) • Healthy subjects
Completed
ANAVEX2-73-002 Study: • Phase 2a (oral) • Mild-to-moderate AD patients • Adaptive trial with Population PK • Bioavailability, dose finding, and exploratory efficacy with 6-month open-label extension
Underway – Preliminary Data: Q3 2015
ANAVEX2-73-00X Study: • Phase 3 (oral) • Mild-to-moderate AD patients • 6/12 month efficacy
Start after Phase 2a
The earliest indication I had that the Company planned to go from Phase 2A to Phase 3 came from this article -
“Speaking of the ongoing trial, the company wanted to avoid the same failure that the other Alzheimer’s drug trials experienced,” Missling told BioSpace. “Therefore, we designed our trial to be a more efficient study than a conventional study with the implementation of an adaptive trial design. We are proud to utilize the latest FDA guidelines in our trial in order to gather as much information as we can from each patient. The data we will gather from this trial will lay a great foundation to lead to a more successful Phase III trial.”
http://www.biospace.com/News/tricon-alzheimers-drug-saw-80-reversal-in-memory/365180
Then the latest (May) presentation clearly shows AVXL's current plan to move directly from Phase 2A to Phase 3.
The May presentation was ~4 months after dozing began for Phase 2A.
I'm thinking that results from the trial have a good chance of getting better as more patients are dozed.
From the poster -
ANAVEX2-73 data is from 12 patients at baseline and day 36 with on-off-on dosing regimen without dose optimization.
http://www.anavex.com/wp-content/uploads/2015-07-22_Poster_AVXL_Phase_2a_AAIC_July_2015.pdf
I feel that AVXL underlined without for a good reason. Either the later dozed patients from the first dataset already received more benefit than the earlier patients or AVXL feels there is a reasonable chance that subsequent data will be better due to doze optimization.
ttj, here's some info on Fidelity's Fully Paid Lending Program -
I spoke with Bruce Chanenchuk (800-481-8313), the head of the dept, after receiving a call asking me if I was interested in loaning shares of another security.
Bruce told me that Fidelity will not lend shares out of individuals accounts unless the account holder has executed a Master Securities Lending Agreement (MSLA). It is a separate agreement from any previously executed margin agreement.
Main reason for the MSLA -
In other words, if your broker borrows shares from your account, these shares are no longer insured and you will lose the value of the shares if your broker goes belly up.
The protection given by Fidelity for the uninsured loaned shares -
The daily short volume is a result of market makers executing trades. I've addressed this before. Here's another explanation -
An explanation of Finra's daily short volume.
(Courtesy of a post made by pantherj)
The daily short interest report from FINRA is as widely misinterpreted as any report ever put out. Yet, once a few basics are understood, it becomes very logical. The huge short volume seen in the daily reports are almost instantaneously covered; within a few milliseconds or a few hours at worst. The best explanation of this report, that I've ever seen, was posted by "Dave Patch" of "Investigatethesec.com."
Posted by: patchman Date: Wednesday, March 03, 2010 6:31:31 PM
In reply to: fourkids_9pets who wrote msg# 648 Post # of 951
Short Sale Volume Reporting’s are deceiving.
I spoke to FINRA today and found out some very interesting things that until now I did not fully understand. I knew there was something wrong with this transparency of information but was not 100% sure what it was. I think I have my answer and it was enlightening.
I was first directed to the Notice to Members memo dated 9/29/2009
www.finra.org/Industry/Regulation/Notices/2009/P120045
The individual I spoke with wanted to make clear that to maintain proper trade volume reporting accuracy, a trade with multiple legs in the trade would only be reported once in the volume reports. The example given would be.
Investor A is long 100 shares and wants to sell. They enter the order through their broker that is routed to a market maker. That market maker will go out and sell the stock into the market before they have bought the stock from you/your broker to close out their account. They do not take possession first as there is no guarantee they can sell the order into the market. By this Notice, the actual sale INTO the market is a short sale because the market maker sold the stock into the market BEFORE they had purchased the stock from you. It is a technicality since they know there position will be closed out minutes later when they go in and buy your shares. To avoid doubling up on trade volume and distorting the picture, only the sale into the market (consolidated tape) is recorded and not the second leg which was the sale transaction between seller and market maker.
So, this is why the short sale volume is high but also why the FTD’s and bi-Monthly short interest reports are not showing any indications of this volume. The short isn’t really a short it is the execution of a long sale by a market maker. The key language in the FINRA notice is this:
Quote:
--------------------------------------------------------------------------------
The Daily Short Sale Volume File will provide daily access to the aggregate volume of short sales in NMS Stocks and OTC Equity Securities reported to a consolidated tape and traded over-the-counter during regular trading hours on each trading day.
You need to ask W&T Capital. He wrote the post.
Much more than a 30 bagger. I used 10 bagger Missling due to this post -
W&T Capital LLC Member Level Thursday, 07/02/15 12:52:02 PM
Re: Reyeton post# 5547
Post # of 16037
My personal belief is we will be bought out. Big pharma is looking to enhance there pipelines and getting in earlier with Anavex will cost them less then if they were to wait until let's say positive phase III. My very first conversation with Missling he spoke about one reason he joined Anavex was he was searching for the next 10 bagger. Well I imagine he won't be waiting to much longer. I'm turning all my friends and close business colleagues onto this "diamond in the rough." Alzheimer's is a market that any big pharma would love to control and Anavex might just be the solution or the fix. We will be bought out way before any phase III begins. Just my 2 cents.
1) 10 Bagger Missling
Why Anavex Is Leading The Race Against Other Pharma To Help Alzheimer's Patients
On July 22, 2015 Anavex Life Sciences Corp (OTCQX:AVXL) released positive phase 2a results for mild to moderate Alzheimer's patients. The company presented these positive phase 2 results at the Alzheimer's Association International Conference 201...
Join Seeking Alpha PRO to get an early look at this article and 11,574 exclusive articles
https://seekingalpha.com/pro/checkout/3470716?notice=pro
Dow futures up 479 @ 6:19 ET
http://www.finviz.com/futures.ashx
Not really, not very specific type at all -
I have told quite a few about AVXL. I provided some info and told them to make their own decision on whether to buy or not. This way, if I make a fortune on AVXL I won't have to hear, "why didn't you tell me about it". My daughter bought 50K and realizes that the 7/22 data release de-risked this investment considerably. She's well aware that she could lose almost all of her $35,000 investment or possibly make 100 X that.
I decided to load AVXL after reading their website, including all of their press releases and media articles and videos - http://www.anavex.com/
This link has some good additional info -
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=116289151
Anavex also included that info in a PR on 11-3-14 -
The Phase 2a study is designed as a randomized trial, with enrollment of 32 mild to moderate Alzheimer’s disease patients at up to 7 sites. Its adaptive design stipulates that data be collected at a number of intervals, including at 3 and 6 months. This provides the opportunity for modification of one or more detailed aspects of the study based on analysis of data. It is believed this advantage will allow the trial to more efficiently demonstrate the effects of the drug. The trial will focus on the following key endpoints: bioavailability, dose finding and dose response, cognitive efficacy, and the relationship of ANAVEX 2-73 as a potential effective add-on therapy to donepezil, the current standard of care.
http://www.anavex.com/?news=anavex-receives-regulatory-approval-to-initiate-phase-2a-clinical-trial-of-anavex-2-73-and-anavex-plus-for-alzheimers-disease
Link to 7/22 Phase 2A poster -
http://www.anavex.com/wp-content/uploads/2015-07-22_Poster_AVXL_Phase_2a_AAIC_July_2015.pdf
Here's my wag regarding trial data releases -
From Spring 2015 Presentation -
Phase 2a – Report preliminary data in Q3 2015
http://www.anavex.com/files/Anavex_Presentation_May_2015.pdf
I would bet that AVXL planned to release the preliminary data for all 32 patients in September. But, after seeing how good the top line data was for the first 12 patients, decided to release that data. Partly due to the patients and care givers raving about the results and asking for a Part B extension. Word of these actions would reach some investors and AVXL had no choice really.
From trial data PR -
“This is the first time the investigational drug ANAVEX 2-73 has been administered to Alzheimer’s patients. In addition to the positive EEG/ERP P300 biomarker signal, the feedback we’ve had so far is that patients and care providers have noticed both cognitive and functional improvement, increased alertness, improvement in activities of daily living, greater organization and a requirement for less prompting,” said study’s principal investigator Dr. Stephen Macfarlane, FRANZCP, Associate Professor and Director of Aged Psychiatry at The Alfred Hospital. “Subsequent to the positive initial feedback, we are applying to expand the extension period from 26 weeks to 52 weeks at the request of the participants.”
http://www.anavex.com/?news=anavex-presents-positive-initial-phase-2a-study-data-with-anavex-2-73-showing-early-evidence-of-improving-cognition-in-patients-with-alzheimers-disease-at-aaic-2015
From the same data PR -
“As of today, we have enrolled two-thirds of the patients. We expect the trial to be fully enrolled and to have PART A completed by the end of the year.”
Part A completed by the end of the year, means that all data has been analyzed. This means that dozing will have to have been completed for all 32 patients by the end of October, at the latest, IMHO.
The unparalleled positive trial data released on July 22nd has to have the Alzheimer's community on the edge of their seats in anticipation of more data. I'm looking for AVXL to give them more partial data in September or October.
Everyone has seen the video. Dr. Missling is brilliant. Check his bio.
AVXL was at .20 earlier this year. Since then a clean Phase 1 has been completed and monumental first data has been reported for the Phase 2 trial. The share price has risen 650% and is barely getting started. Institutions come after $5.00 and Nasdaq up list. You can't expect an OTC stock to trade in double digits overnight.
You're fortunate to know about AVXL early. What you do with that knowledge is, of course, up to you.
This is what the SA author had to say about AVXL this week -
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.
Posted by MrKerfluffle on another board -
This Is How You Make Hundredfold Gains in the Market
By Chris Mayer, editor, Mayer's 100x Club
Wednesday, August 12, 2015
"Every human problem is an investment opportunity if you can anticipate the solution," the old gentleman told me. "Except for thieves, who would buy locks?"
I just met this remarkable fellow, full of wisdom on investing, yet hardly known beyond a small group of fans. His name is Thomas Phelps, and he's had quite a career. He was the Wall Street Journal's Washington bureau chief, an editor of Barron's, a partner at a brokerage firm, the head of the research department at a Fortune 500 company, and, finally, a partner at Scudder, Stevens & Clark (since bought out by Deutsche Bank).
Phelps retired in Nantucket after a varied 42-year career in the markets. Along the way, Phelps figured out a few things about investing…
He conducted a fascinating study on stocks that returned $100 for every $1 invested.
Phelps found hundreds of such stocks, available in any single year, that you could have bought and enjoyed a 100-to-1 return on – if you had just held on.
This was the main thrust of our conversation: the key was not only finding them, but keeping them.
His basic conclusion can be summed up in the phrase "buy right and hold on."
"Let's face it," he said, "a great deal of investing is on par with the instinct that makes a fish bite on an edible spinner because it is moving." Investors, too, bite on what's moving and can't sit on a stock that isn't going anywhere.
They also lose patience with one that is moving against them. This causes them to make a lot of trades and never enjoy truly mammoth returns. Investors crave activity, and Wall Street is built on it. The media feeds it all, making it seem as if important things happen every day. Hundreds of millions of shares change hands every session.
But investors need to distinguish between activity and results. "When I was a boy, a carpenter working for my father made this sage observation: 'A lot of shavings don't make a good workman.'" As you can see, Phelps is a man of folksy wisdom.
"Investors," Phelps continued, "have been so thoroughly sold on the nonsensical idea of measuring performance quarter by quarter – or even year by year – that many of them would hit the ceiling if an investment adviser or portfolio manager failed to get rid of a stock that acted badly for more than a year or two." What investors should do is focus on the business, not on market prices.
Phelps showed me financial histories of a long list of companies – earnings per share, returns on equity and the like. No stock prices. After one example, he asked, "Would a businessman seeing only those figures have been jumping in and out of the stock? I doubt it." But if they just sat on it, they'd be rich. And this is the nub of it.
Phelps is not a fan of selling good businesses. He talked about how his friend Karl Pettit – an industrialist, inventor and investor – sold his shares of tech firm IBM many years ago to start his brokerage business. He sold them for a million bucks. That stake would eventually go on to be worth $2 billion – more than he ever made in his brokerage business.
Phelps also told me the story of how he sold his shares of former filmmaker Polaroid to pay a steep doctor's bill of $7,415 back in 1954.
"Here is the confirmation of the sale," he said, and he keeps it as a reminder of his folly. Less than 20 years later, his Polaroid stock was worth $843,000. That's an expensive doctor's visit. Phelps also stands against market timing. He told me about how he predicted various bear markets in his career.
"Yet I would have been much better off if, instead of correctly forecasting a bear market, I had focused my attention through the decline on finding stocks that would turn $10,000 into a million dollars." Because of his bearishness, he missed opportunities that went on to deliver 100 to 1.
"Bear market smoke gets in one's eyes," he said, and it blinds us to buying opportunities if we are too intent on market timing.
"He who lives by the sword shall perish by the sword," he added. "When experienced investors frown on gambling with price fluctuations in the stock market, it is not because they don't like money, but because both experience and history have convinced them that enduring fortunes are not built that way."
Phelps showed me a little table that reveals how much and for how long a stock must compound its value to multiply a hundredfold:
Return
Years to 100-bagger
14.0% 35
16.6% 30
20.0% 25
26.0% 20
36.0% 15
You'll note these are very long holding periods – especially in an age when the average holding period for stocks is measured in months – but that's the point. The greatest fortunes come from gritting your teeth and holding on. You'll also see it's a fairly high hurdle to get to 100-bagger status. You need high growth for a long time.
For example, farming-equipment store Tractor Supply grew earnings at a rate of 23% per year and became a 100-bagger after just over 12 years. Energy-drink maker Monster Beverage became a 100-bagger in just 10 years – a remarkable feat that required a 50% annual growth rate.
Phelps advises looking for new methods, new materials, and new products – things that improve life, that solve problems and allow us to do things better, faster and cheaper. There is also an admirable ethical streak to Mr. Phelps' style, as he emphasized investing in companies that do something good for mankind. This requires looking beyond past figures.
"There is a Wall Street saying that a situation is better than a statistic," Phelps said. Relying only on published growth trends, profit margins, and price-to-earnings ratios is not as important as understanding how a company could create value in the years ahead. Phelps is quick to add he is not advocating blindly holding onto stocks.
"My advice to buy right and hold on is intended to counter unproductive activity," he said, "not to recommend putting them away and forgetting them."
Now, I have a little confession to make about Mr. Phelps… I didn't actually meet him. He has been dead since 1992, reaching the ripe old age of 90. Every quote above comes not from a conversation, but from his book, 100 to 1 in the Stock Market: A Distinguished Security Analyst Tells How to Make More of Your Investment Opportunities, published in 1972.
I recommend the book, which is a pleasure to read and has plenty of good ideas, analogies, and stories. They are particularly relevant now, given all the trouble in the world. I am inspired by Mr. Phelps' philosophy of buying right and holding on. You should try to do more of that, too.
Regards,
Chris Mayer
Thanks a lot -
Glad you found this gem!!!
TY Cp -
Pretty soon we will find out how "newsy" AVXL wants to be regarding the Phase 2a trial. The first data release was monumental and certainly didn't need the MMSE and Cogstate scale numbers to be impactful. These numbers could probably be released in the near future. The data on the second "group" of patients and the 3 month numbers on the first "group" of patients should be known to AVXL near term. I'm curious to see how often AVXL intends to release data and if Dr. Missing will ration out the data.
ANAVEX 2-73 showed in 83 percent (10/12) of patients positive cognitive effects during PART A of the study, which consists of a 36-day on-off-on not-yet-optimized dosing regimen to assess bioavailability. At day 36, the amplitude of the cognitive EEG/ERP biomarker P300 increased 38 percent from baseline. Published data suggests that a 38 percent increase is approximately 4 times higher than donepezil (Aricept®), the current standard of care, in the same timeframe.
Preliminary measured Mini Mental State Examination (MMSE) and Cogstate scale changes are consistent with the observed trend of the cognitive EEG/ERP effect. The safety profile of ANAVEX 2-73 during Phase 2a appears consistent with the Phase 1 data; additional clinical data of the trial will be presented at future medical meetings.
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://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
Anavex May Actually Cure Alzheimer's
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.
If 2-73 is successful, then nothing you cited is a problem. AVXL should be able to partner with terms at least as good as the example below. Three years after this partnership, PCYC was bought for $21 billion. That price would be $105 a share for AVXL with 200 million fully diluted shares.
What makes this scenario even better is that the CNS market is many times what PCYC's market was and AVXL may have no formidable competition.
Partnership example - PCYC was in early and mid-stage studies when they partnered with Janssen Biotech (JNJ) -
Pharmacyclics Scores Big With Janssen Biotech Deal
Dec 12 2011, 10:13 by: The Burrill Report | includes: JNJ, PCYC
By Marie Daghlian
Janssen Biotech, a unit of Johnson & Johnson (JNJ), is paying Pharmacyclics (PCYC) $150 million upfront for rights to co-develop and market its lead anti-cancer compound PCI-32765. The first-in-class oral Btk inhibitor blocks signaling in a critical pathway needed for tumor growth and proliferation. It is currently in early- and mid-stage studies across a variety of blood cancers, including non-Hodgkin’s lymphoma.
In addition to the upfront payment of $150 million, Sunnyvale, California-based Pharmacyclics will be entitled to receive up to $825 million in development and regulatory milestone payments. The companies have agreed to share development costs for oncology and other indications, excluding inflammation and immune-mediated conditions, with Pharmacyclics paying for 40 percent of the costs and Janssen picking up the rest. The partners will share profits equally in a 50/50 profit-loss agreement. Both companies will book revenue, Pharmacyclics in the United States and Janssen in the rest of the world.
The deal is expected to be slightly dilutive to Johnson & Johnson's 2011 earnings per share on the order of approximately 4 to 5 cents. William Hait, global head of cancer therapeutics for Janssen, said in a statement that PCI-32765 has broad applicability and the partnership is an “opportunity to bring a new form of oral therapy to patients with B-cell malignancies.”
Pharmacyclics has no marketed products. Its first product candidate, an injectable cancer drug, was rejected by U.S. regulators in 2007. Although the deal gives Pharmacyclics a hefty upfront payment, investors were not thrilled by the deal. Several analysts issued downgrades for the company citing its lack of revenues, and a market cap almost equal to the potential deal size.
These are the entities involved in the debenture financing -
Auriga Global
Auriga Investors-Montserrat
Hudson Bay Master Fund
DAFNA LifeScience LP
DAFNA LifeScience Market Neutral
DAFNA LifeScience Select L.P.
Joann Mostovoy
Sabby Healthcare
Sabby Volatility Warrant Master Fund
Sphera Global Healthcare Master Fund
HFR HE Sphera Global Healthcare Master Trust
The 2013 Lincoln Park financing never really got off the ground. It was resurrected through a 6-19-15, S-1 filing.
http://www.sec.gov/Archives/edgar/data/1314052/000106299315003474/posam.htm
westeffer had an excellent post regarding the cost of Alzheimer's Disease -
The Alzheimer statistics/costs are astounding. Any drug that can improve cognitive ability will be a mega blockbuster. Current world wide cost of $605 Billion or 1% of world wide GDP. Estimated US cost in 2015 is $226 Billion.
http://www.alzheimers.net/resources/alzheimers-statistics
Costs are staggering!
Fast drug approval -
Steve Harris, MD from University of Utah School of Medicine
World record is presently AZT (zidovudine) which went from first dose of drug by injection to human in a pharmacodynamic study to FDA approval as treatment for AIDS, in 20 months (July 1985 to March 1987). From start of the first 6 month clinical trial in AIDS patients to approval, was about 13 months. Review was about 6 months.