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Agree. This move has a totally different flavor than previous. Not worried about MF or AF hit pieces anymore. No powder left. The only thing that can derails us now is bad results; highly unlikely based on what has been demonstrated to date.
GLTA longs and medicine.
We should be required to file 13R(etail)- LOL. I am guessing you and I are in the 100K + shares club.
This run feels completely different. Our patience is about to pay-off big. Believe it!
Thanks for posting. This is very meaningful. More to come.
Company Overview
Park West Asset Management LLC is an employee owned hedge fund sponsor. It provides its services to private investment vehicles offered to foundations, endowments, high net worth, financially sophisticated individuals and institutional investors. The firm manages separate client-focused portfolios. It launches and manages hedge funds for its clients. The firm invests in the public equity and fixed income markets. It employs long/short, event-driven and credit/high yield investing strategy to make its investments. Park West Asset Management LLC was founded in November 2002 and is based in Larkspur, California.
You tha man!
I suppose if it takes more than $600K.
12 weeks.
I am not saying that $20 mill is enough to fund any trials. Facts:
AD P2 funded by Aussies - Expect more for P3
Parkinson clinical funded by MJF Rett Foundation. Expect more for next phase.
Rett clinical to be funded by Rett Foundation
Would not be suprised to get funds from the US gov for AD trial
it is you who clearly does not understand. Capisce? Comprende?
Done with this.
"WE HAVE EN9UGH CASH IN HAND TO FUND OPERATIONS FOR 2 YEARS" (PERIOD)
Can't ignore grants to fund trials because they are a fact. This has already been demonstrated by the Australian P-2. We can expect additional funding for the ~300 patient p-3 to be started this year. Recruitment under way already. What is it that you don't understand? Is it that hard?
Don't forget about safety.
With all the good things going on with this company, this is what you worry about? Better use of your time is to watch Dr.M in the most recent video. Impressive!
Here is the link:
http://www.thedeal.com/pharma-outlook-for-2017/
Our CEO is getting noticed. Bain?
Saganaki, never had it but will try it.
Agree with your assessment about PPS.
Peanuts? I think of it more like caviar. I guess that might make me half full rather than half empty. That view has served me well in business and in life in general. You might want to try it.
The idealist.
Trying to spin this as not good news is futile and frankly stupid. Those in charge of the Rett Foundation most be in on the con, if you know what I mean. Fly AVXL.
If P-2 is successful the FDA will provide fast-path designation for Anavex 2-73 for Rett; combined with orphan status, the rocket will launch and reach its destination.
Plato(nic) disaster for some.
Cheers!
The word minimum indicates that the .6 will be spent if needed and more could be made available if required. The opposite, maximum, would indicate they could pull the plug before the .6 is spent, if they felt at any point during the trial that it would be futile to continue.
From today's PR:
.....Rettsyndrome.org today announced that Rettsyndrome.org has committed a financial grant of a minimum of $0.6 million to cover the majority of a planned U.S. multicenter Phase 2 clinical trial of ANAVEX 2-73 for the treatment of Rett syndrome.--------------
The way I read it is that the Rett Syndrome Foundation is leaving the door open for additional grants if required to see this through; of course, early results will determine what they do. The key word: "a minimum of $0.6 million".
Realism does not imply to argue against one self. In this case, if invest and try very hard to keep that investment from paying off I would call that stupid rather than realistic. Whitman.
...and you said that there will be no P3 until 2018. Do you have information we don't have?
I believe Falconera provided fact-based answers to some of the dilemmas you seem to have regarding the data and overall results presented by Anavex. Satisfied?
Hopefully, you now will stop trying to create unnecessary FUD. Legitimate questions/challenges are always more than welcome. This board is lucky to have a good balance of scientific, investing and connecting the dots inteligencia, to provides us all with balanced views upon which we can make our investing decisions. Ultimately, I believe that most of us are as interested about realizing the benefits to humanity, should Anavex compounds prove to be successful, as we are about our own financial benefit.
You have a choice of becoming a contributor to the board or to go away as you promised, should your questions be answered.
The ball is on your court Sir!
Despicable!
Is the FDA involved?
NEW YORK, NY, November 18, 2015 – Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: 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, announces that it is moving forward with the development program for ANAVEX 2-73. Guidance received from the FDA confirms the Company’s strategy to advance ANAVEX 2-73 for the treatment of Alzheimer’s disease in a larger double-blinded, randomized, placebo-controlled Phase 2/3 trial.
“Working with a highly vulnerable patient population, the Company is proceeding in a rational, step-wise process. Armed with the necessary data from the Phase 2a study to optimally design future trials, we look forward to expanding our development program,” said Kristina M. Capiak, Vice President Regulatory Affairs of Anavex.
“The utilization of Adaptive Design and Population Pharmacokinetics/Pharmacodynamics (PK/PD) modeling is a major strength of the Phase 2a study. By implementing a different, innovative trial design for ANAVEX 2-73 in Alzheimer’s treatment, it is believed that this is more efficient than a conventional Phase 2 study since it is designed to reduce the risk of a Phase 3 trial failure, as well as receiving the best quality information we can about ANAVEX 2-73,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. “The advantage of having Population PK/PD data is of value for the development of ANAVEX 2-73 in Alzheimer’s disease and also for other potential CNS indications.”
...they are back.
Thank you! Your insight is so profound that is making me rethink my investment strategy. NOT!!
From SA article:
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Despite small numbers and the lack of a placebo in the Anavex trial, having some initial improvements that are maintained for more than six months is extraordinarily rare in the treatment of Alzheimer's disease (study).
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Thank you!
2017 should be an exiting year for Anavex investors and humanity at large.
Excellent summary of what we can expect. If the Dr. delivers 2/3 of the list in 2017, we should expect to be rewarded.
Thank you!
Tom,
Thanks for helping keep this board from becoming a trash bin.
One comment regarding taking short positions on this or any other early stage bio, we could wake up one day to a bid that is double the previous close on news. Obviously, the oposite can happen with negative news but the long exposure is limited, while the short is not. Shorting for small gains can turn into a financial nightmare.
--TWST: What drug candidates are the farthest along in the pipeline? Where are they and when could they potentially be commercialized?
Dr. Missling: The most of advanced compound in our pipeline is ANAVEX 2-73, which is now in a Phase 2a clinical trial in 32 mild-to-moderate Alzheimer’s patients. The next most advanced compounds are ANAVEX 3-71 and ANAVEX 1-41, which are both at the pre-IND stage. The next stage of clinical trials is in preparation for ANAVEX 2-73: a larger Phase 2/3 study as well as another Phase 2 in an orphan indication, and it could be Rett syndrome.
TWST: Is this for Alzheimer's?
Dr. Missling: We will conduct the Phase 2/3 for Alzheimer’s.
--
TWST: Before we go on to other things, can you tell about the SIGMACEPTOR Discovery Platform is? Also, is this something that you are just using internally in the company or is it something that you outlicense or seek to outlicense?
Dr. Missling: SIGMACEPTOR is a high-throughput screening for discovering small molecule drugs with different affinity for targeting the sigma-1 receptor, and yes, it indeed can be outlicensed. SIGMACEPTOR is the core of the company because this is the basis for discovering compounds that target the sigma-1 receptor, among other important targets, which are relevant and involved in restoring cellular functions and homeostasis. This might be critical to improving the lives of patients suffering from both neurodevelopmental and neurodegenerative indications.
TWST: When you call it a discovery platform, can you provide a little more insight into what the platform consists of? Is it a screening system or a particular process?
Dr. Missling: We focus on small molecules, which are orally available, versus biologics, which typically must be injected. If you can give a patient a pill or oral formulation to take, then that is easier to administer compared to an injection for which you will need a physician or a nurse. Also, some people just don't like or tolerate injections. But the focus indeed is on small molecules.
----TWST: Did you want to say anything further on partnerships?
Dr. Missling: For larger markets like Alzheimer’s disease, partnerships for commercialization are very common. This is something that no small company can market by itself and, for that reason, at some point in time, there will be certainly discussions in that direction.
TWST: When might that be happening? Perhaps pre-Phase 3 or afterwards?
Dr. Missling: Our goal is always to create the highest possible value for shareholders. When you enter into such a collaboration or partnership for a larger indication, we will always try to aim for improving the outcome for the shareholders.
TWST: Are there any significant management or operational changes likely to take place in the next year and, if so, can you elaborate on what they might be and what they are for?
Dr. Missling: We are consistently growing in a thoughtful manner and we are adding people selectively because we are still relatively small. So this will be at an incremental and carefully considered pace. We intend to have several clinical trials up and running next year. One will likely be an orphan indication. All those trials will be double-blind placebo-controlled studies.
-------
TWST: As a CEO, what is your chief challenge right now? And what are you doing to address it?
Dr. Missling: The chief challenge is really to keep in mind that drug development has inherent risks, and we would like to address those in order to reduce those risks to the extent possible. So we try to always do everything to the best of our knowledge and ability to minimize clinical trial risks in particular. That is the most important task for us and for me.
Ok. You made your point.
Happy trading!
Falconera, thanks for contributing so much to help us understand the science. Your post seem to be based on facts, objective and not endorsing blind faith investment. We each have the duty to conduct our own DD to find opportunity to increase/preserve our assets. It is even more meaningful when investing in companies that do good for humanity. I believe Anavex is in that category and I will continue to maintain a substantial (for me at least) portion of my stock investment in AVXL.
I understand why you feel the way you do, about posting here. While I don't provide the same level of contribution to the board as you do, and therefore will not be missed, but like you I will also not be posting for now.
Happy Holidays and good luck!
Some one has been accumulating heavy at 3.91-.92
Could we put the placebo argument to rest? If giving A-273 to all who need it results in their enjoyment of life again (placebo effect) then let the A-272 placebo be available to all who want it. It does no harm right?
I am ready to take a daily dose of A-273 now!!! Willing to pay $10/per tablet.
OK, i know that this opinion sounds ignorant but it is difficult to understand how anybody can make an argument tha the results of the Australian trial can be attributed to placebo. Saying that it is a hoax may have more credence than that.
Cheers!
Thanks! Your knowledge and insights are greately appreciated.
I find it interest that there are only 56 holders of record. Do they only count the broker as 1 for all its customers? That is my guess. Can someone clarify?
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As of December 12, 2016, there were approximately 56 holders of record of our common stock. As of such date, 39,610,967 shares of our common stock were issued and outstanding.
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Thanks!
I do think that the Dr. negotiated a good arrangement. That is why he has not been worried about funding and does not have to give in on an arrangement with a partner that does not meet his requirements; "we will do what is best for the share holders".
You might be correct that it is up to $100Mil
I believe they have a line to $50M. Rember, the Dr. controls the terms of when and how much. I don't believe he will need more for the rest of 2017. This arrangement with LPark is actually quite good, despite their well deserve reputation for being hard-money lenders.