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The strategy is called, wait for it, INVESTING!!!
Who's right or wrong and the science means everything for those of us that are holding for FDA approval.
Today's share price, next months share price, and next years share price mean next to nothing.
GLTY
The claims made by the ambulance chasers are false-
From 10-K -
On December 22, 2015, the Company received a subpoena from the Securities and Exchange Commission (SEC) which indicates that the agency is conducting a formal investigation. The Company believes the subpoena and investigation relate to the recent unusual activity in the market for the Company’s shares. The Company is fully cooperating with the SEC in this investigation and is unable to predict when this matter will be resolved or what further action, if any, the SEC may take in connection with it.
Reply from IR -
hooperg83 Tuesday, 12/29/15 03:15:10 PM
Re: Bullish91 post# 46646
Post # of 46782
You are incorrect.
I just spoke with Christine Payne from Primoris. She indicates that AVXL received a subpoena from the SEC regarding abnormal trading of their security. She indicates that this subpoena does not involve the corporate officers of AVXL.
This is likely an investigation of what happened in November, specifically naked short selling.
The share price pulls back, so it's game over?
LOL, good one!
Let these words sink in -
From 10-K -
On December 22, 2015, the Company received a subpoena from the Securities and Exchange Commission (SEC) which indicates that the agency is conducting a formal investigation. The Company believes the subpoena and investigation relate to the recent unusual activity in the market for the Company’s shares. The Company is fully cooperating with the SEC in this investigation and is unable to predict when this matter will be resolved or what further action, if any, the SEC may take in connection with it.
Reply from IR -
hooperg83 Tuesday, 12/29/15 03:15:10 PM
Re: Bullish91 post# 46646
Post # of 46782
You are incorrect.
I just spoke with Christine Payne from Primoris. She indicates that AVXL received a subpoena from the SEC regarding abnormal trading of their security. She indicates that this subpoena does not involve the corporate officers of AVXL.
This is likely an investigation of what happened in November, specifically naked short selling.
Occasionally there is pertinent info on Seeking Alpha. This interview with Dr. Macfarlane is noteworthy -
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.
The author wouldn't want to ruin a hit piece by reporting on the remarkable trial data.
Melissa Davis
Short only, contrarian, special situations
What happens if the 12 week results are as remarkable as previous results?
AVXL up to $20.00?
That bogus quote is from an ambulance chaser's website.
From 10-K -
On December 22, 2015, the Company received a subpoena from the Securities and Exchange Commission (SEC) which indicates that the agency is conducting a formal investigation. The Company believes the subpoena and investigation relate to the recent unusual activity in the market for the Company’s shares. The Company is fully cooperating with the SEC in this investigation and is unable to predict when this matter will be resolved or what further action, if any, the SEC may take in connection with it.
Reply from IR -
hooperg83 Tuesday, 12/29/15 03:15:10 PM
Re: Bullish91 post# 46646
Post # of 46782
You are incorrect.
I just spoke with Christine Payne from Primoris. She indicates that AVXL received a subpoena from the SEC regarding abnormal trading of their security. She indicates that this subpoena does not involve the corporate officers of AVXL.
This is likely an investigation of what happened in November, specifically naked short selling.
It's good because there is an ongoing investigation of stock manipulation. I trust that AVXL's end will come up clean and that the short manipulators will be pinched.
Long term positive for AVXL -
On December 22, 2015, the Company received a subpoena from the Securities and Exchange Commission (SEC) which indicates that the agency is conducting a formal investigation. The Company believes the subpoena and investigation relate to the recent unusual activity in the market for the Company’s shares. The Company is fully cooperating with the SEC in this investigation and is unable to predict when this matter will be resolved or what further action, if any, the SEC may take in connection with it.
Nonsense!!!
Martin S. may be snitching already and the SEC is swinging into action.
Added 8,000 @ 6.11.
It was posted over there that AVXL only had 4 employees. north40000 wanted to post that that was incorrect and provide more info. He did the right thing to provide more info.
Please go ahead and post it. They know you over there.
The last 10-K, dated 12/29/14, lists -
Employees
We currently have four (4) full-time employees, and we retain several independent contractors on an as-needed basis. We believe that we have good relations with our employees.
AVXL PRs show these added recently -
http://www.anavex.com/?news=anavex-announces-executive-overseeing-regulatory-affairs
http://www.anavex.com/?news=anavex-expands-management-team
AVXL also added the neurologist/part time model.
We should find out the new total this week from the fiscal 2015 10-K.
AVXL's IR sent out this message explaining that the lab has been shut down. This is a major factor contributing to the low number of employees -
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.
One man holds all of these positions-
Christopher Missling, PhD -
Director, President, Chief Executive Officer, Chief Financial Officer, Secretary, Treasurer
You're welcome! I'm really looking forward to the next data release. We were given a small sample of what to expect on 11/9 -
The washout period was included in the 5 week timeframe of Part A -
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.
http://www.anavex.com/?news=anavex-announces-positive-primary-and-secondary-endpoints-were-achieved-in-a-phase-2a-clinical-trial-of-anavex-2-73-in-alzheimers-disease%e2%80%8e
Part B timeline does not include the 5 week Part A -
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.
bernardc gave us this excellent report that included 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!!!
http://www.anavex.com/wp-content/uploads/2015-11-07_Anavex_Presentation_CTAD_2015_Macfarlane.pdf
From the first data release -
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.
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
More remarkable data from the second data release -
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.”
http://www.anavex.com/?news=anavex-announces-positive-primary-and-secondary-endpoints-were-achieved-in-a-phase-2a-clinical-trial-of-anavex-2-73-in-alzheimers-disease%e2%80%8e
HAPPY HOLIDAYS!!!
Flash mob performances at a mall and the Smithonian -
http://www.mormonnewsroom.ca/article/montreal-mormons-gather-in-a-flash-mob-to-celebrate-christmas
Thanks for sharing this -
hooey ?(uncountable)
1.(slang) Silly talk or writing; nonsense, silliness, or fake assertion(s). [quotations ?]
I heard his speech. It sounded like a whole lot of hooey to me.
That gumshoe article is more placebo effect hooey.
Dr. 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
To extend A2-73's patent expiration date when it is used in combination with donepezil. A patent for A2-73 Plus would expire in 2033.
Additional U.S. patent applications filed for pharmaceutical composition of matter for ANAVEX 2-73 will, if granted, provide further patent protection until at least 2035. An additional patent application on file for ANAVEX PLUS, the combination of ANAVEX 2-73 and donepezil, if granted, will provide protection for composition of matter until at least 2033.
There is such a thing as advertising and social media. Cost and insurance coverage would be the only barriers. Awareness would be a given.
A patent for A2-73 Plus may or may not come. I think the only benefit of the patent to AVXL would be to extend the patent protection for A2-73 when it is used in combination with donepezil.
AVXL's pre-2a data showed that A2-73 Plus outperformed A2-73 alone in mild to moderate AD. The 2a dosing is set up to gain more info from A2-73 Plus as 24 patients are on A2-73 + donepezil while 8 patients are on A2-73 only.
I expect AVXL to continue forward with A2-73 Plus and seek FDA approval for the combo. A2-73 may have to be run through separate trials to gain FDA approval as a stand alone preventative and as a treatment for very early stage AD.
If AVXL pursues FDA approval for A2-73 first, the trial results will probably be less impressive than A2-73 Plus would be and there may be insurance reimbursement issues with using A2-73 off-label with donepezil.
All IMHO
The short attack on the other stock you own was mere child's play compared to the coordinated attack on AVXL.
Avxl ... 34mm O/S ... 70mm shares traded in 2 week decline
CTIX ... 120mm O/S ... 15mm shares traded in 4 week decline
The coordinated criminal attack on AVXL was absolutely brutal!!!
From AVXL website -
Why is Anavex conducting a reverse stock split?
Anavex is executing a 1-for-4 reverse stock split with the intention of listing its common stock on the NASDAQ Capital Market. Anavex believes that such a listing could attract a broader, more diverse shareholder base. By executing a reverse stock split, we intend to fulfill one of the quantitative requirements to become a NASDAQ-listed company.
Do you really think AVXL would be trading above $0.50 if the R/S and uplist hadn't happened? If so you are probably dreaming!
The coordinated criminal attack by Street Sweeper, SA, AF, JF, the prison bound boy, and many others would have absolutely crushed an OTC stock. Be thankful that Missling chose the right path and that we survived the attack.
I would take 2-73 as a preventative pill right along with the multi vitamin I take. I don't have any health issues or vitamin deficiencies, that I know of, but, I still take the vitamin as a preventative. As do millions of others.
I would say that you hit the nail on the head. A2-73 Plus can be approved, patent or no patent. Once approved, Anavex will be the only one that can sell A2-73 Plus.
24 of 32 on donepezil too -
7. Do you think you will have even better results by adding donepezil to 2-73? Why? Are there plans to do that?
The population pharmacokinetic and pharmacodynamic analysis will reveal that, since we included both donepezil-treated (24/32) and donepezil-naive (8/32) patients in our trial. In other words, 75% of our sample have had ANAVEX 2-73 added to donepezil as part of the study protocol.
http://seekingalpha.com/article/3672856-anavex-life-sciences-interview-with-dr-stephen-macfarlane
The share price has climbed from $0.60 (post split) to its current level due to remarkable trial data.
Next trial data should be available next month.
The Motley Fool author failed to consider a partnership into his financial outlook for AVXL. However, he was smart enough to consider the LPC financing as a positive -
Admittedly, the company has some financial flexibility thanks to an unconventional financing deal it inked with Lincoln Park Capital Fund earlier this year. In that deal, Anavex Life Sciences gave Lincoln Park Capital Fund 179,598 shares up front in exchange for Lincoln Park's agreement to buy $50 million in Anavex Life Sciences stock over the next three years. That could give Anavex Life Sciences enough funding to get trials under way, but it's unlikely to be enough to usher Anavex 2-73 all the way through phase 3. As a result, this deal (and additional future share offerings) could dilute current investors pretty significantly. For that reason, I think it makes sense to sit on the sidelines and let this company mature a bit before jumping in and buying.
Quadruple Witching Hour could launch stocks: This Friday, December 18, four major types of investment vehicles expire at the same time — an event that typically causes huge volatility in the markets.
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.
We know we'll get the Anavex Plus patent. We just don't know when yet.
I think MK is full of it. This from the Microsoft Technology Center website –
Sphere 3D stands apart as the provider of Glassware 2.0™, which is the industry’s first Windows containerization technology. Though the industry has been abuzz with the premise that Linux containers are the new and efficient way to deliver application virtualization, it is often missed that these Linux containers do not apply to the majority of Windows based applications that are in production in corporate IT infrastructures around the world.
http://wwmtcstudios.com/en/Events/2016-02-08%20The%20Fastest%20Way%20to%20Containerize%20Your%20Applications%20An%20Interview%20with%20Sphere%203D
This from Novarad PR –
Under the terms of the agreement, Sphere 3D and Novarad will establish a rolling 90 day schedule for refreshing healthcare facilities with virtualization technology throughout the United States. It is anticipated that the first sites will be implemented in the third quarter of 2015. The solutions to be rolled out will be configured to address the specific needs of each facility, and will include a combination of virtualization technologies including the award-winning V3 hyper-converged platform, Glassware 2.0, and SnapScale® and SnapServer® lines of storage products.
http://sphere3d.com/sphere-3d-and-novarad-enter-into-master-purchase-agreement-to-deliver-virtualization-capabilities-to-400-healthcare-facilities/
It sure sounds to me like Glassware 2.0 works!
No, shares and warrants from a previous purchase agreement are being registered. The $1.50 is an average of recent prices and is only to establish the fee ANY has to pay to register these.
This prospectus relates to the resale or other disposition by a selling shareholder identified in this prospectus, or its transferees, of up to an aggregate of 393,939 outstanding common shares and 393,939 common shares issuable upon the exercise of outstanding warrants. These securities were issued to the selling shareholder pursuant to a purchase agreement, dated August 10, 2015, between us and the selling shareholder party thereto, as amended, as a result of the triggering of certain price protection provisions in the purchase agreement following the issuance and sale of common shares and warrants pursuant to the subscription agreements we entered into on September 22, 2015 and October 6, 2015 and the subscription and purchase agreements we entered into on November 30, 2015.
Very experienced investors have told me that L2 may only show 10% of the number of shares that are at the bid and ask. Sometimes less than 10%. They feel that L2 is almost worthless for stocks like AVXL.
I think the below post is spot on -
Pieterpanne Thursday, 10/08/15 04:25:38 PM
Re: WolfWayne post# 22398
Post # of 44314
Could be reserve purchases... in E*Trade Pro you can enter a buy for, let's say 10,000 shares and there is a box you can check (reserve amount) that will show only 100 share being purchased instead of 10,000 in the L2, if I recall correctly.. supposedly so "they" don't see your desire to accumulate a large block and chase the price "ask vs bid" up as you buy... Just my 3 cents worth... may be incorrect.. but who knows..