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I'd like to add at cheaper prices myself. However, I have to say this is about as low as one can go.
Response to today's news from a doctor who specializes in epilepsy -
Big news for the epilepsy world!
by dadofmarcmax • 45 minutes ago Flag
.
Ok, so infantile spasms (new nomenclature is "epileptic spasms") mostly occurs between 4 months -7 months of age but can occur at any age and presents as sudden flexion of arms,legs with tonic posturing. The EEG shows a pattern called hypsarrythmia and the spasms show a classic slow wave followed by generalized paroxysmal fast activity with electrodecrement. It is thought to be the result of some sort of insult to the brain either structurally or related to a genetic defect.....many causes. Furthermore, spasms are thought to occur as a result of an inflammatory cascade, hence ACTH as a strong corticosteroid works (strong anti inflammatory properties). I have always stated that 2-73 works to stop neuroinflammation and with this news; we may have a new and less potentially dangerous medication than ACTH to treat spasms.
West syndrome (where spasms are seen), if not controlled early after diagnosis leads to devastating developmental consequences.
This is BIG news in the epilepsy world. Again, this is why I'm so heavily invested in AVXL; the potential to change neurology as I know it is huge! I'm glad I'm in early.
I think Anavex will be busy sending out grant applications after the upcoming data is released.
No doubt that heavy shorting temporarily depresses share price. The problem is that shorts will find shares to short. If not, they will naked short.
apostrophe's NSS post is timely.
Fidelity has told me that they do not loan account holders shares to shorts without a signed contract with the account holder.
Something of interest:
Fidelity's mutual funds loan shares they hold to shorts. I imagine that all mutual funds do this. The explanation I was given is that the mutual fund managers are bullish on the long term outlook for stocks they hold. They are not worried about a stock being shorted and then covered, resulting in a wash. Futhermore, they are interested in receiving the interest in order to bolster their returns.
You're welcome -
The reason for the escrow account is this:
Please note that the fully paid securities on loan are not covered under the provisions of the Securities Investor Protection Act of 1970.
The escrow account insures that you won't lose the value of your shares if Fidelity goes belly up.
I have participated in Fidelity's Fully Paid (meaning you have no margin balance) Lending Program in the past. If you have a margin balance, Fidelity can borrow shares from your account without paying you interest.
The total of all of your accounts at Fidelity must exceed $250,000 to be eligible.
The interest rate you receive varies and can change daily. Up and down.
If your shares are in a margin account, the shares you loan out are moved to a cash account once borrowed.
Fidelity sets up an escrow account at Wells Fargo and deposits the value of the shares you loan out. The amount in the escrow account changes daily to reflect the closing price of the stock you loaned out. You receive interest on the value of the escrow account. The interest is recorded daily and paid to you once a month.
Fidelity collects interest from the shorts and pays you about 60% of what they charge. Today, Fidelity is charging the shorts 24% and paying the owner of the shares 15%.
You can sell the shares you loaned out at any time. You receive a cash credit in your margin account as soon as you sell shares you have loaned out. It usually takes 2 days for the cash credit to become cash in your account. You can buy with the cash credit, in the meantime, but, you have to enter your order over the phone.
Thanks, basparks79, for attending the annual meeting and reporting!
From your post-
Nice little quote from today's SA article -
If the 12/26 week data is good, all other problems associated with this company and its stock-real, exaggerated, or imagined will not matter. A long position on Anavex 2-73 seems warranted.
http://seekingalpha.com/article/3973477-anavex-2minus-73-hints-success
The most common share repurchase method in the US is the open-market stock repurchase, representing almost 75% of all repurchases. A firm will announce that it will repurchase some shares in the open market from time to time as market conditions dictate and maintains the option of deciding whether, when, and how much to repurchase. Open-market repurchases can span months or even years. There are, however, daily buy-back limits which restrict the amount of stock that can be bought over a particular time interval again ranging from months to even years. Per SEC Rule 10b-18, The issuer can't purchase more than 25% of the average daily volume.[/I]
https://en.wikipedia.org/wiki/Share_repurchase
I received this from IR a week ago. It sounds like we will hear of more applications in the months ahead -
Thank you for your email and interest in Anavex Life Sciences Corp. (Nasdaq: AVXL).
The latest press release issued regard a patent related to ANAVEX 2-73 was issued on August 12, 2015. You may view it here: www.anavex.com/?news=anavex-receives-notice-of-allowance-for-u-s-patent-application-related-to-anavex-2-73.
Anavex is extremely focused on the patent position of ANAVEX 2-73 and related drugs. The company is engaged in a rigorous patent filing and prosecution effort to protect Anavex in all forms, methods of use, and methods of production. Patent applications are necessarily published 18 months from filing. When published, the investor community will be free to review these patent applications. At such time, the investor community will be able to evaluate the scope of patent protection sought and granted.
Patents enjoy a minimum term of 20 years from the earliest claimed filing date. For various reasons, this term may be extended for up to five years by the Patent Office.
Please do not hesitate to contact our office if we can be of further assistance.
On behalf of Anavex Life Sciences Corp.,
Investor Relations
Toll Free (North America): 1 (866) 505-2895
Outside North America: +1 (416) 489 0092
Fax: +1 (416) 352 5239
ir@anavex.com
The article you provided a link to was from April, 2015. At that time Biogen's drug showed some early promise. The $2.5 billion total cost included all trials and a four year construction project to build a new manufacturing facility.
Since then -
UPDATED: In a setback, Biogen's mid-range dose of aducanumab flops in Alzheimer's study
http://www.fiercebiotech.com/r-d/updated-a-setback-biogen-s-mid-range-dose-of-aducanumab-flops-alzheimer-s-study
Phase 3 oncology trials average around $40,000 per patient according to this - http://www.phrma.org/sites/default/files/pdf/biopharmaceutical-industry-sponsored-clinical-trials-impact-on-state-economies.pdf
Most oncology trials involve IV dosing and/or radiation. Alz trials should be much cheaper with the patient sitting at home taking a pill and going in for testing once every 3 months.
In spite of that, let's use $40,000 per patient times 300 (Missling's highest estimated number of patients for phase 3) to figure cost of A2-73 phase 3 -
$40,000 X 300 = $12 million
Let's double that (600 patients) = $24 million
Let's double that again (1,200 patients) = $48 million
Thanks to viperdeal -
viperdeal Friday, 12/18/15 09:16:30 AM
Re: None
Post # of 61190
Email response from Teresa Touey:
Hi Darrell,
Rep Burgess was not in attendance....The following members and/or their staff attended:
Participating Members and their staff:
1) Rep Patrick Meehan
2) Rep Joseph Kennedy III
3) Rep Tim Murphy
4) Rep Garrett Graves
Staff for:
1) Rep Brendan Boyle
2) Senator Cory Booker
3) Senator Joni Ernst
4) all the representatives above sent staff also
Teresa Touey
Sorry to hear about your mom. AD is such a devastating disease. I read yesterday that AD is the #2 cause of death in Australia.
According to this post on Yahoo, Anavex is distancing themselves from the media blitz -
Email from IR today:
Thank you for your follow-up email and continued interest in Anavex Life Sciences Corp. (Nasdaq: AVXL).
Anavex was not involved in the recent media coverage from Australia. No new data was revealed in the stories and Dr. Macfarlane had commented on measured cognitive and functional benefits plus overall improvement in mood in the March 10th press release.
Please do not hesitate to contact our office if we can be of further assistance.
On behalf of Anavex Life Sciences Corp.,
Investor Relations
Clearly, the patients are getting better as their duration in the trial lengthens!
123tom,
Did it ever occur to you that flippers would have sold way before AVXL hit the fourteens?
There was a group of flippers that bought in about a year ago at ~ $.20. They sold during the pullback from .47 to .28 and didn't buy back in.
If/when AVXL gains FDA approval, these flippers will have cost themselves a fortune.
Selling at least some after a huge parabolic run makes sense. Selling due to the share price pulling back to a pivot point can be very, very costly.
Thanks for posting this.
Lots of comments on the video.
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://investorshub.advfn.com/boards/read_msg.aspx?message_id=122166515
Alzheimer's Disease Breakthrough: Melbourne drug trial achieves amazing results
Videos of patients that have had their Alzheimer's Disease reversed -
http://video.dailytelegraph.com.au/v/455096/Steve-Macfarlane-explains-the-Alzheimers-worldfirst-drug-trial-at-Caulfield-Hospital
http://www.msn.com/en-au/video/w/alzheimers-breakthrough-in-melbourne-drug-trial/vp-BBsbgnI
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.
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.
Exactly, and as posted previously, Dr. Missling has estimated the Phase 3 trial number at 100-300 patients.
From IR -
In terms of the number of participants in the Phase 2a trial, this is because of the adaptive design of the trial (versus a trial that includes patients receiving a placebo). Here is a summary of comments made by Dr. Tasos Zografidis, the Vice President Clinical Operations of Anavex, and Dr. Christopher Missling, President and CEO, in a conference call earlier this year, which provides additional insight into the reasons Anavex is using an adaptive trial design.
TZ: For background information, there are two approaches in a clinical trial. One is the placebo controlled study. Here you have to estimate the number of patients needed if you are testing a hypothesis since you need a certain power; you need a certain number of patients. However, the methodology that we are using is very different, we just measure whatever effect is there. If you measure the effect and are able to reproduce it mathematically (mathematical modeling), then you can calculate the number of patients needed so as to see the effect. By using the adaptive trial methodology with population PK modeling, we are implementing mathematical modeling along with probability density function statistical methodology. That means that the results are looked at in confidence intervals. In the first approach you first estimate the number of patients and then you "see" the effect. In the second approach you first measure the effect and then you calculate the patients needed so as to truly "see" the effect. So, these are two opposite approaches with same outcome.
CM: We want to get a signal and the adaptive clinical trial allows us to increase the dose or decrease the dose until we see a signal. The mathematical model that Tasos speaks of sufficiently allows us to measure the data from these 32 patients because we are measuring many data points in this trial, from blood samples and the various cognitive tests, which allows for sufficiently precise data to learn how the drug works in order to select the number of patients needed for a Phase 3 pivotal trial. The number could range anywhere from 100 to 300 and the goal is to figure that number out.
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 ([1]). 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.
Dr. Macfarlane expressed a view that is shared by many clinicians -
http://www.fiercebiotech.com/financials/will-eli-lilly-s-11th-hour-regulatory-gambit-salvage-or-sink-its-alzheimer-s-drug?mkt_tok=3RkMMJWWfF9wsRokuKnMd%252B%252FhmjTEU5z17%252BktUaK%252Fg4kz2EFye%252BLIHETpodcMSspjNbrYDBceEJhqyQJxPr3HJdQN18R7RhHnDg%253D%253D&mrkid=%257B%257Blead.Id%257D%257D&utm_medium=nl&utm_source=internal
There has not been a Notice of Effect issued by the SEC. AVXL has not applied for one.
Anavex filed this S-3 on 10/23/15 -
http://www.sec.gov/Archives/edgar/data/1314052/000161577415003018/s102056_forms3.htm
The filing included this in red ink -
The information in this prospectus is not complete and may be changed. This prospectus is included in a registration statement that we filed with the Securities and Exchange Commission. We may not sell these securities or accept an offer to buy these securities until the registration statement filed with the Securities and Exchange Commission is effective. This prospectus is not an offer to sell these securities, and it is not soliciting offers to buy these securities in any state where such offer or sale is not permitted.
Anavex would have to file a complete prospectus in order to gain a Notice of Effectiveness from the SEC. They have not. Therefore, Anavex is content to let the original filing collect dust.
I wouldn't be surprised if Dr. M has been on the phone non-stop with tutes that want to learn more about the Company and the first drug to ever reverse the devastating effects of AD.
IMO, the big buyers aren't here yet, but, they are coming.
Here's another link to try, then click the link above the picture.
http://www.scoopnest.com/user/dailytelegraph/724111623779172353
This link worked yesterday -
http://www.scoopnest.com/out/?url=https://t.co/2oaugZU7ps&id=724111623779172353
It seems as though it will let you view once and the next time the subscription page comes up.
I have no clue where it will settle in the short term either.
However, I do think that the news of A2-73 reversing ALZ will push the share price up over time.
Short covering may add to the rally. We'll see.
Thanks Doc,
I love the news. REVERSAL!!!
Thanks for posting that article.
Obviously, the bottom line is this -
Time for an EXPERTS opinion -
An experts view on placebo effect -
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.'
This quote is from Dr. Macfarlane. He has been running Alzheimer's trials for 16 years.
http://seekingalpha.com/article/3672856-anavex-life-sciences-interview-dr-stephen-macfarlane
Nice post!
The flippers that are out are not going to like your common sense logic!
I think all of us longs have been waiting for some word on the longitudinal effect of A2-73 in AD patients.
For Ms Stevens to have been diagnosed with AD 3 years ago and go thru 28 months of decline, and then regain the ability to play the piano after 8 months on A2-73 is awesome! REVERSAL!!!
Quote:
After 55 years of playing the piano, Ms Stevens lost the ability to play three years ago, and was soon after diagnosed with Alzheimer’s disease.
Pauline Stevens, 78, has regained the ability to play the piano after taking a revolutionary new drug for Alzheimer's. Picture: David Caird.
Eight months ago she began having a daily pill of Anavex and it is now impossible to wipe the smile from her face as she jokes and plays the piano for her family. “I feel as though I can go and do things now that I couldn’t do. I am happy,” Ms Stevens, 78, said.
“I love playing, I love to sit down and play like I used to.”
Wiping away tears of joy as he listens, husband Tom Stevens said the turnaround has been remarkable.
“Pauline laughs at my jokes again. I have her back,” he said.
“We are at the beginning, but there is hope now where there wasn’t.”
We don't know the time frame details for Ms Lynch, but, we do know that she has been dosed with A2-73 for at least 6 months. REVERSAL!!!
Quote:
Ms Lynch, 76, has not only picked up her paintbrushes again, but is preparing for an exhibition spanning the last 50 years of her work despite being diagnosed with Alzheimer’s in November 2014.
“People used to say that I had forgotten things or that I had already told them something, and I just said I had a lot to remember and couldn’t remember everything,” Ms Lynch said.
“Everything is better around me. I feel quite well.”
Ms Lynch’s carer Keith Everitt can recall her “going downhill fast” as she stopped painting and had difficulty around her home before joining the trial.
“It has improved her out of all sight. She is laughing and bubbly, she has absolutely blossomed since she has been on these tablets,” he said. “Nobody can believe the difference in Valerie before the trials and now. It is a different person.”
Thank you for that post. The truth will win in the end!
Reversal of Alzheimer's Disease at 8 months and at least 6 months. This is the kind of news that the average investor can understand.
HUGE HUGE HUGE!!!
Over the next week or so, a bunch of new, potential investors will be introduced to AVXL!!!
To Dr. Macfarlane, seeing real improvements to patients is much more important than seeing a statistically significant improvement on a rating scale, no matter how good the numbers are.
I think all of us longs have been waiting for some word on the longitudinal effect of A2-73 in AD patients.
For Ms Stevens to have been diagnosed with AD 3 years ago and go thru 28 months of decline, and then regain the ability to play the piano after 8 months on A2-73 is awesome! REVERSAL!!!
Don't know. Anavex had previously made A2-73 available to researchers through Tochris. Maybe, Tochris folded or didn't pay their bill.