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Falcon,
Good perspective as usual.
For me the appointment of Dr. Fadiran is an endorsement from a seasoned FDA insider who believes that Anavex has the goods. Likewise, Dr. Missling continues to shore up the management team in preparation for the critical steps that need to be taken between now and hopefully commercialization.
Obviously, the most important step is to validate the efficacy and continued safety of the drug(s) with positive results from well organized/conducted Ph-3 trials. Until then the market will remain skeptical, albeit with encouraging signs by the increasing number of institutions taking positions in the stock.
Cheers!
Bio,
Once again, thanks for providing us with facts and smart commentary to go along.
Your posts, as those of many other key contributors to this board, are the reason that I come back even if it means wading through some of meaningless "stuff" posted by some.
Thank you!
Hopefully we will find out soon.
I don't recall how long in remained on the website. In any case, very puzzling and still unexplained. Let's hope it was an unplanned move due to late breaking development with possible partnership.
Remember when we got a peak? this was posted on the conference's website as a placeholder. Why was it removed and not presented?
13th International Conference on Alzheimer’s and Parkinson’s Diseases.
http://adpd2017.kenes.com/
Abstract:
15-MONTHS SAFETY AND EXPLORATORY EFFICACY DATA OF ANAVEX 2-73 IN A PHASE 2A STUDY IN MILD-TO-MODERATE ALZHEIMER’S DISEASE PATIENTS
Aims
ANAVEX2-73, a selective sigma-1 and muscarinic receptor agonist was tested in a Phase 2a-study in patients with mild-to-moderate AD. Adverse Events (AEs) were recorded for assessment of safety and maximum tolerated dose (MTD). Cognitive (MMSE, Cogstate, QEEG/ERP) and the functional (ADCS-ADL) marker were measured so as to establish a functional relationship between dosing regimen and exploratory efficacy outcomes.
Method
Thirty-two AD patients 55-85 years old with MMSE 16-28 were recruited. After establishing MTD and dose-response all patients received ANAVEX2-73 between 10mg and 50mg daily orally and re-assessed every 3 months. For safety, mathematical modeling was fitted to the recorded AEs to establish the dose-risk relationship. For efficacy, statistical hypothesis tests were performed on cognitive and functional markers and compared to the corresponding baselines.
Results
Safety: ANAVEX2-73 demonstrated a favorable safety profile in AD patients. The most common AEs were grade 1. Positive unexpected therapeutic response events, such as improved mood, improved social engagement and increased independent activities were recorded.
Exploratory Efficacy: 15-months data demonstrate that ANAVEX2-73 preserves average MMSE and ADCS-ADL scores and shows benefits over baseline for Cogstate and QEEG/ERP.
Conclusion
The safety of ANAVEX2-73 was assessed and MTD was determined. Despite not optimal dosing, both cognitive and functional performance is sustained over at least 12 months, suggesting that the effect of the compound does not seem to worsen AD symptoms with repeated dosing. In a progressive degenerative disease this is considered a positive outcome. The data support further clinical development of ANAVEX2-73 and preparation for a larger confirmatory study is underway.
Co-authors
C. Missling 1
1, USA
Thanks for posting.
This just more confirmation that funding is not an issue. Dr. M. wants to be sure that PH-3 will succeed by knowing what type of patients will react most positively to the drug. Not, ethical to patients or best for shareholders to proceed with uncertainty.
I believe patience will be rewarded here.
GLTA
Fireman,
No doubt we all wish to have more concrete information about schedules, data, etc. However, by saying more than he perhaps should have, Dr.Missling has created expectations that have been inflated in message boards. I believe that he has been asked, by the legal team, to pass on only what is certain (i.e. Rett Foundation grant award) and to do it through the proper channels.
Investing in early stage Biotechs requires an immense amount of patience and risk tolerance. Not providing advice about how you should investment, just offering some perspective.
GLTY
We don't know if there is activity regarding a take over. However, based on the potential of Anavex, it is only prudent to have the mechanism in place to fend off a low bidder.
My opinion is that Dr. M has had discussions about potential partnerships and, as he stated at the ASM, BP's want to see more data. If the results from the Australian trial continue to be positive, that might be the trigger to enter into an agreement. BIIB is certainly very interested.
Bas, you are absolutely correct.
from Investopedia:
There are two types of poison pills. I believe we just approved #1. # 2 could also be part of a deal which could include cash plus shares of the acquiring/surviving entity.
1. A “flip-in” permits shareholders, except for the acquirer, to purchase additional shares at a discount. This provides investors with instantaneous profits. Using this type of poison pill also dilutes shares held by the acquiring company, making the takeover attempt more expensive and more difficult.
2. A “flip-over” enables stockholders to purchase the acquirer’s shares after the merger at a discounted rate. For example, a shareholder may gain the right to buy the stock of its acquirer, in subsequent mergers, at a two-for-one rate.
BREAKING DOWN 'Poison Pill'
The term poison pill is the common colloquial expression referring to a specially designed shareholder rights plan. A defensive tactic enacted by a company’s board of directors, poison pills, at least, cause an aggressive takeover plot to be rethought. At most, a poison pill may deter a takeover altogether.
Read more: Poison Pill http://www.investopedia.com/terms/p/poisonpill.asp#ixzz4f11MCeOo
Follow us: Investopedia on Facebook
Bio,
I look forward to your next DD post. Like you, I am in for the long unless the fundamentals change, which I seriously doubt they will.
Bio,
Thanks for your insightful post. You logically laid out plausible outcomes. I am of the opinion that a partnership is where we end up and then we move into the rougher waters of late stage trials with a stronger ship. Not that any ship is exempt from sinking if it runs into an iceberg, if you know what I mean.
Cheers!
My apologies to those who have been in the market long enough and waist a few minutes watching this video. However, I do believe that there are many following/posting on this board who can benefit from revisiting the basics of investing to help them decide if AVXL is where they want to invest their hard-earned money.
Full disclosure: I have been long AVXL since October 2015 and have accumulated a good number of shares >100k with an average prices of $5.50.
This I have done because I believe in the scientific premise, the results of the various trials, the CEO and his BOD, the credentials of the SB and I am prepared to lose a substantial amount of my investment since I consider this to be a speculative investment-as most early stage bios are. I try not to provide investment advice, although I admit that sometimes I may get caught up on the subject de jour and express my sentiments with the long bias and detest the nonsense posted by some. Take a look at this short video and hopefully it will help some, on both sides of the isle, decide how they approach AVXL investment going forward. Remember that longs are exposed to losing no more than what they are willing to put in; shorts on the other hand are exposed to greater loses.
GLTA and enjoy the rest of your weekend!
http://marketbusinessnews.com/financial-glossary/speculative-investment/
I agree. There is still enough valuable info shared on this board to continue coming back. I am long for the long as well.
Cheers!
FYI
----
Dear xxxxx,
Thank you for your email and interest in Anavex Life Sciences Corp. (Nasdaq: AVXL).
Results will be shared in the coming days via an 8K filing, which you may access via EDGAR.
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 contents of this e-mail are confidential and may be legally privileged. It is intended solely for the addressee. Access to this e-mail by anyone other than the addressee is unauthorized. If you are not the intended recipient (or responsible for delivery of the message to the recipient), you should inform the sender at the e-mail address from which this message was transmitted or call +1 416 489 0092 and delete this message from your system and destroy any hard copies. Unauthorized use, disclosure, copying or distribution is prohibited and may be unlawful.
From: xxxxxx via ir [mailto:ir@anavex.com]
Sent: Tuesday, April 18, 2017 2:19 PM
To: ir@anavex.com
Subject: Shareholders Meeting
Are we going to get a transcript or highlights from the ASM?
Thank you.
...or they work form entities trying to scoop up cheap shares
Sorry, not true:
Misconceptions about orphan drug designation:
"2. There can be only one orphan designation per indication
Not only can there be multiple orphan designations per indication; more than one sponsor can receive an orphan designation for the same drug/indication. However, only the first drug to be approved for a given indication will enjoy the benefits of orphan approval. A product with a different active moiety can also receive orphan approval for an already approved orphan indication. Additionally, a second sponsor may gain orphan approval for a previously approved orphan drug/indication if the second sponsor’s product demonstrates increased clinical benefit, e.g. oral administration instead of intravenous.
Lady and Gentlemen,
Have you thought about starting a message board to cover Neuren? Hopefully both companies will achieve success in treating this horrible decease and provide a better life for those girls.
I like your idea. I also don't think shorts need to be banned as long as they present their arguments based on facts or hypotheses that follow logic.
It is good to maintain an open mind to pro/con positions.
One of your best posts.
Thank you!
Thank you! Not obvious to me until I read your post. For ever grateful.
For sure.
I agree. We are all anxiously awaiting more concrete news about the issues you reference in your questions. I personally believe that the news about start of the Rett's trial is imminent and that will open up the gates.
MHO of course. I remain a strong believer.
Cheers!
Tom, it has already been stated that at this meeting they could not disclose anything that is not already know by the general public. Does that answer your questions?
Thank you! Long we remain.
Cheers!
Thanks Bourbon. Was there a Q&A? Can you provide a bit more color?
Thanks for posting. Maybe some of the PHD's on this board (we know who they are) will start believing their fellow intellectuals about the possibility that Anavex might just have the goods.
Plato,
You are putting your self at risk with these lies.
The SEC cleared Anavex of any wrong doing and there is no additional action under way. That is a lie.
As far as your allegation regarding BIIB. They could easily walk away since all they signed up was to test A-273. No financial agreement was made or they would have to disclose. So this is rubbish.
Happy Easter.
A good Kentucky bourbon would also be nice.-:)
Keep in mind that shorts turn into friends of the longs when the squeeze comes. They will be chasing to cover when the boom is lowered.
AVXL!!
Vote yes for all board recommended items. I believe there are 5 or 6. Very simple.
Go into your brokerage account and you should find it in your documents section.
Anavex is one of the victims of the promoting scam. Anavex has been cleared by the SEC of any wrongdoing in stock promotion by 3rd. parties.
These scams are done by unscrupulous people who pump/dump/short stocks. Many of these promoters will be doing time.
You Sir, are trying to do the same on this board. Careful.
Accumulation continues. I would not be at all surprise if institutional holding is in the 30% range for the quarter. Transfer of wealth.
....and that is why Dr.M. continues to say that he wants to ensure success in Ph-3 by mining the data to establish a trial that would succeed, or not do it at all. "Unethical".
Absolutely right Ruby. Also, notice the date:
Another Alzheimer’s Drug Fails in Large-Scale Trials
Flurizan's maker says it will discontinue work on the drug
by Jim Schnabel
June 30, 2008
Just more attempts to introduce FUD.
There is no announcement. Did you set your exit strategy yet?
The FUD here today is thicker than London fog.
Significant business development news coming soon. I believe we will hear before annual SH meeting on the 17th.
There have been glitches with the exchange systems. I think you are SOL when that happens.
"In reality, in a fast market when the stock gaps down (during flash crashes, breaking news, or fake tweets), your stop loss is triggered. The bad news is that it will be triggered at the next available market price, which could be many points lower.
In other words, your stock could be automatically sold at the lowest price, and instead of locking in a 5% loss, you could lose much more.
Another problem with a stop loss order is that when you enter it into the computer, the order is transparent. A game that some market-makers played (these days, it will be computer algorithms) is “run the stops,” when the stock is forced low enough to trigger a large cluster of stop loss orders (usually at round numbers or well-known support and resistance levels). After the stock is sold at a popular stop loss price, the stock reverses direction and rallies.
The biggest problem with stop losses is that you have given up control of your sell order to the computer. During volatile markets, that can cost you money."