Your post is a year late.

Heading into AAIC 2015 we didn't know if A2-73 worked in humans and had very little safety data.

Heading into AAIC 2016 we already know that A2-73 works in humans and that the safety profile is excellent.

Currently, we are just waiting to find out how much better A2-73 is than donepezil at 31 weeks.

Well stated falconer66a!

I attended 2 conferences where I had an interest in a company. Both times the company gave an oral presentation which consisted of the presenter speaking a mile a minute in order to finish the slide show in time. I garnered almost no information from either presentation. There was no time for Q&A either time.

I went to each of these presentations with the hope of speaking to the CEO (presenter) after the presentation. No luck, they both had private meetings set up and didn't have time to talk.

No more oral presentations for me. Poster presentations only.

Your background gives you a better understanding than most of us.

Glad you are onboard!

I feel that AVXL has what the aging world needs and that a medical breakthrough is imminent.

For those that haven't read this and could possibly be swayed by BS posted on this message board -

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 (http://www.fda.gov/downloads/Drugs/Guidances/ucm201790.pdf). The FDA states that with the adaptive trial design, which we are using, you need fewer patients, you are able to do this in a shorter period of time, you are more likely to demonstrate the effect of the drug, and you are getting more information on the treatment effect as well as a better understanding of dose response information in subgroups. Lastly, you are able to identify and optimize the parameters needed for Phase 3 effects. So, this Phase 2a trial is a very important stepping stone and building block for a successful Phase 3 trial. We want to avoid the same failure that the other Alzheimer drug trials experienced, and by implementing a different, innovative trial design for ANAVEX-73 in Alzheimer’s treatment, we are leading a more efficient study than a conventional study.

Drugs that don't work have huge patient enrollment numbers and never ending trial completion dates. Nothing before and nothing currently being trialed has shown anything close to Anavex's drug results.

CEO Missling predicted that A2-73's Phase 3 would enroll 100-300 patients.

Your link is about shareholders borrowing money and using their shares for collateral. We have been discussing shareholders loaning shares to brokers.

Totally different. There is no timeframe for shares loaned to your broker. The shares can be sold at anytime or the loan can be cancelled at anytime.

I have been told the same thing. Also, Fidelity and Schwab would not be paying shareholders 30% and 25% if they could lend these shares without shareholder permission and keep the money for themselves.

In order for shares to be loaned from your account at Fidelity -

Brokers wouldn't call shareholders asking if they would like to participate in a fully paid lending program if the brokers could raid shareholders accounts and loan shares to the shorts without a signed contract between them and the share owner.

Fidelity is currently charging shorts 48.25% on the value of AVXL shares that they borrow from them. Fidelity is paying fully paid lending program participants 30% on the value of the shares they have loaned to Fidelity. Fidelity would not pay participants this 30% if they could get around it by raiding their accounts for shares to loan to the shorts.

This happens if a shareholder signs a fully paid lending program contract with Fidelity -

Shareholder can designate how many of his shares can be loaned to Fidelity. If no designation, all shares are available to Fidelity.

This bolded info is in the Fully Paid Lending Program -
Please note that the fully paid securities on loan are not covered under the provisions of the Securities Investor Protection Act of 1970. This may be what prevents the brokers from raiding accounts for shares to loan.

Fidelity sets up an escrow account with a bank, in the shareholders name, and adjusts the dollar amount daily to match the value of the shares the share owner has loaned to Fidelity. This escrow account is to protect the shareowner now that there is no insurance on the value of the loaned shares.

Shareholder can sell the shares that he has loaned to Fidelity at anytime. Shareholder can also call and cancel the lending agreement at any time.

There may be one scenario where your broker can loan your shares without your permission. Notice that the above refers to "Fully Paid Lending Program". If your account has a margin debit, then your shares are not fully paid for. In which case, your broker owns a percentage of your shares. I do not know if this scenario would give a broker access to loan out these shares without your permission or not.

Don't ever expect the price to go up everyday. No matter what you own.

I have seen the data too, have you?

Think about it. We have had 3 data releases. Nothing illegal about saying, I have seen the data.

You are saying that U.S. citizens plus permanent resident aliens of the U.S. own less than 50.1% of Anavex? Come on!!!

BTW, 50%+ ownership equals control due to Anavex not having any preferred shares that have extraordinary voting rights.

Come on, Tom. Do you really think that the NIH isn't itching to provide a $100 million grant for the only drug that has shown reversal for a disease that will bankrupt Medicare.

You continually harp about financing. Have some vision!

Thank You for the outstanding post. The LPC agreement is there if Anavex wishes to pursue it.

Will they? I hope so. Then, Anavex sells shares on their terms, with no warrants, when they want to, instead of the financers or hedge funds hustling our Company.

We all value the contributions Miss Australia has made. To suggest that you are making investment decisions based on her posts is equivalent to telling her; Please don't post here anymore.

If you don't think so, then maybe it will.

Awhile back you posted that AVXL was going to 10 cents.

~75% of Dr. Missling's compensation for the next 3 years will be options. Options have no value unless the share price rises. Considering the fact that Dr. Missling met every milestone of his first 3 year contract, I was expecting him to receive a larger contract.

If the average option grant share price is $10.00, he will get 600,000 options; $15.00, 400,000 options; $20.00, 300,000 options. This is for 3 years. I can't find fault with this.

While the patent apps play out -

Keep in mind the 5 years of market exclusivity that would be granted to Anavex if FDA approval is obtained from the current trial path.

In 5 years Anavex can test combos of A2-73 and other drugs and develop A3-71.

I'm encouraged by the latest reply by the patent examiner regarding A2-73 and donepezil. While the examiner is looking for more proof of synergy for A2-73/donepezil, he did concede that they are synergistic.

Anavex may have been granted extra time due to adjustments for delays within the USPTO.

Thanks for the reply. George and Mike pointed me in the right direction.

It appears to me that Anavex is claiming synergistic and the examiner is claiming additive and obviousness.

It may be a good sign that the examiner included this in his last Advisory Action -

The bolded (by me) portion seems to admit that A2-73 and donepezil are synergistic. I agree with you that Anavex can meet the full scope of claims by dropping galantamine, rivastagmine, and memantine from the application.

The melanoma patent is a future endeavor for the Company.

Familiarize yourself with the Company's pre-clinical results and the gold mine the Company is pursuing with their current patent aspirations.

Nice call!!!

Now, Swami, do you mind calling the top for us?

GL

Thank You

Thank You

The patent provides IP protection until at least 2035 -

NEW YORK, NY, August 12, 2015 – 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.
http://www.anavex.com/?news=anavex-receives-notice-of-allowance-for-u-s-patent-application-related-to-anavex-2-73

Can anybody tell me how to access the back and forth between Anavex and the patent office regarding patent app 13/940,352? I found the patent app, but, don't know where to look for the back and forth.

This sounds like it could be a very big deal for an Anavex Plus patent allowance. Can you provide a link?

This patent is a combination patent as is the Anavex Plus patent application. I think that protection for A2-73, when dosed by itself, will come from FDA approvals of Orphan Drug Designations that dose A2-73 alone.

I think Anavex will be assigned plenty of patents and FDA approval exclusivity in the future.

I am not a patent expert.

SUMMARY OF THE INVENTION

In view of the foregoing disadvantages inherent in the prior art, the present invention provides an improved sigma(a) receptor ligands and method for using, and overcomes the above-mentioned disadvantages and drawbacks of the prior art. As such, the general purpose of the present invention, which will be described subsequently in greater detail, is to provide a new and improved sigma(a) receptor ligands and method which has all the advantages of the prior art mentioned heretofore and many novel features that result in a sigma(a) receptor ligands which is not anticipated, rendered obvious, suggested, or even implied by the prior art, either alone or in any combination thereof.

To attain this, the present invention essentially comprises a method for using a compound including sigma(a)-receptor ligands and a sigma(a) ligands generics. The method includes the providing of a compound having a sigma(a)-receptor ligands and a sigma(a) ligands generics, wherein the sigma(a) ligands generics is selected from Quinacrine, analogues of Quinacrine, Methylene blue, analogues of Methylene blue, Astemizole, and analogues of Astemizole. Then method further includes using the composition for the preparation of pharmaceuticals.

The pharmaceuticals have anticancer, antimetastatic and antiviral activity associated with analgesic properties.

Yes, then A2-73 plus Aricept would be considered for approval due to them being dosed together. That is what we want. If the Anavex Plus patent goes thru it will be good until 2033.

If the patent doesn't go thru, then A2-73 gets 4 or 5 years (I've seen both numbers mentioned) of market exclusivity.

Not sure, but, it would seem likely that A2-73's market exclusivity could be extended with each approval of an Orphan Drug Designation.

The information posted by Caulfield Hospital stated that all patients will be taking Aricept.

Anavex says this in their Spring Presentation -

ANAVEX™2-73-00Y Study: • Phase 2/3 (oral) • Mild-to-moderate AD patients • Double-blind, placebo controlled study • 6/12 month efficacy

Note placebo controlled study.

Someone posted info on the next A2-73 trial at Caulfield Hospital. The patients for that trial are required to be taking Aricept. If Anavex continues to dose A2-73 and Aricept in their future Alzheimer's trial(s), then Anavex Plus is what will be considered for FDA approval.

The Anavex Plus patent is very important at this juncture.

I'm going with -

"This type of Adaptive Design cannot use blinding period?"

Professor Maurice didn't say that Anavex choose not to blind the trial. He said -

"These trials cannot be blinded ..."

To be more accurate, the current trial has been designed purposely by using state-of-the-art Population PK/PD and Adaptive Design. The "adaptive design" is only referring to dosing adaptations. Protocols itself can not be changed. Moreover, the design followed FDA guidelines (see below source). These trials cannot be blinded and do not required a control. Source: Professor Maurice provided links to these two sources (1, 2).

2.75 is the 200 week moving average.

Hi F1ash, I knew I had read a statement saying the trial cannot be blinded. I finally remembered where I had read that.

Professor Maurice also wrote in a second email:

After carefully checking the mail I sent to you, I want to clarify some points that could be misunderstood:

1) The mail reflects only my personal thoughts, as a preclinical researcher involved in the pionnering work on the compound. I demonstrated the symptomatic and neuroprotective effects of the compound in several mouse models of AD. But I have no competence to discuss the clinical protocol used by the company.

2) In answer of question 1, I wrote "The idea is to be able to adapt the protocol and get the maximum information they can." It was too imprecise. To be more accurate, the current trial has been designed purposely by using state-of-the-art Population PK/PD and Adaptive Design. The "adaptive design" is only referring to dosing adaptations. Protocols itself can not be changed. Moreover, the design followed FDA guidelines (see below source). These trials cannot be blinded and do not required a control. Source: Professor Maurice provided links to these two sources (1, 2).
http://seekingalpha.com/article/3687706-anavex-interview-professor-tangui-maurice

I find it odd that Anavex was able to secure patent protection on A2-73 until 2035 after a patent on A2-73 was issued in 1997.

The PR stated -

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.

It's going to be interesting to find out what these "Additional U.S. patent applications" cover.

The 8/12/15 PR -

NEW YORK, NY, August 12, 2015 – 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.

The allowed patent claims cover formulations and treatments that provide particular coverage relating to improved sigma receptor ligands and their use.

“This patent is a valuable addition to our IP portfolio and covers innovations we have made in our development efforts for ANAVEX 2-73 and beyond,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. “We have filed numerous patent applications to cover promising compositions and therapies, including those pertaining to ANAVEX 2-73, in keeping with our commitment to a comprehensive IP protection strategy.”

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.

The USPTO issues a Notice of Allowance after it determines that a patent should be granted for a claimed invention that is novel in comparison to all known technology in existence. Based on the timing of this Notice of Allowance, Anavex expects the patent to be issued by the end of 2015.

Very well stated!!!

Slide 5 of this presentation illustrates the above -

http://www.anavex.com/files/Anavex_Presentation_Spring_2016.pdf

jimmy667 Sunday, 05/01/16 05:57:44 AM
Re: XenaLives post# 61228
Post # of 65989

WE MUST DEFEND "THE PEARL OF INESTIMABLE VALUE" This is our time these are our people! This PEARL may shine for us all. We can not let this great discovery be subsumed into the avarice of the few. We can fight we can band together as believers to do our little parts as retail investors to bring this great discovery to fruition for the benefit of humankind.

As XENA and others have opined SWING TRADING may have diminishing returns at this point. (It plays into the hands of the shorts)

If we BAND together we can defeat the MM and possible RICO manipulators.

I PROPOSE that each of us continue to accumulate systematically on regular intervals, rather than swing trade to improve position.

The ACCUMULATOR of the number 1558 shares has shown us the blue print by buying everyday that set amount. Imagine if many of us emulated that?

Such a system removes much of the volatility risk out of the equation and will result in having a superior position overall.

I for one have initiated transfer funds to systematically ACCUMULATE shares. I chose the numbers 667, 1334 and 2001. By these numbers I will show my commitment and they might be discernible in the daily time and sales record. (I would not ask anyone to do what I am not, provably, doing myself)

LEAD, FOLLOW or Get Out of the Way.
GO AVXL!

This is how -

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=123529595

If market makers anti up enough, brokers will allow them to execute trade orders. Profiting from filling orders is their business. Manipulating the market is not their business.

Good post -

Prana's drug was a good candidate for failure. It was not reversing the effects of Alzheimer's like A2-73, just possibly slowing progression.

Macfarlane's enthusiasm during the Prana trial was directed at one patient. Currently, his enthusiasm is for the entire A2-73 trial.

Macfarlane said that the drug seems to have slowed the progression of the disease by about 30 percent in patients with mild Alzheimer’s compared to placebo.

https://www.equities.com/news/prana-biotechnology-pran-continues-upward-on-alzheimer-s-disease-drug-news

Xena,

The MMs are at the bottom of the food chain. They have to pay in order to be allowed to facilitate trades. They have no influence on market pricing. The people, funds, entities that employ algos move the market -

For a stock that trades in an over-the-counter (OTC) market, such as the Nasdaq, your broker may send the order to a "Nasdaq market maker" in the stock. Many Nasdaq market makers also pay brokers for order flow.
http://www.sec.gov/investor/pubs/tradexec.htm

Hedge funds, yes. MM, no.

In today's world of ECNs for limit trades (maybe 90%+ of volume?), and broker options, the MM is of little consequence.

Your Broker Has Options for Executing Your Trade
Just as you have a choice of brokers, your broker generally has a choice of markets to execute your trade:

•For a stock that is listed on an exchange, such as the New York Stock Exchange (NYSE), your broker may direct the order to that exchange, to another exchange (such as a regional exchange), or to a firm called a "third market maker." A "third market maker" is a firm that stands ready to buy or sell a stock listed on an exchange at publicly quoted prices. As a way to attract orders from brokers, some regional exchanges or third market makers will pay your broker for routing your order to that exchange or market maker—perhaps a penny or more per share for your order. This is called "payment for order flow."

•For a stock that trades in an over-the-counter (OTC) market, such as the Nasdaq, your broker may send the order to a "Nasdaq market maker" in the stock. Many Nasdaq market makers also pay brokers for order flow.

•Your broker may route your order – especially a "limit order" – to an electronic communications network (ECN) that automatically matches buy and sell orders at specified prices. A "limit order" is an order to buy or sell a stock at a specific price.

•Your broker may decide to send your order to another division of your broker's firm to be filled out of the firm's own inventory. This is called "internalization." In this way, your broker's firm may make money on the "spread" – which is the difference between the purchase price and the sale price.
http://www.sec.gov/investor/pubs/tradexec.htm