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There is no reason the could not follow with a conference call and PR to discuss all of the results. Most of the many other Biotechs I have invested in do this.
I know, where is the rest of the data that is significant to PDD, the purpose of this trial. Maybe it will be presented in the scientific journal. It will be an even bigger disappointment if they don't present all the information there. You have a wonderfully accepting and optimistic nature.
God bless you.
I sold half, but not soon enough being caught by meetings. It was a risk I was willing to take based on previous PR. I just got caught on the wrong side. Kudos to Tom again! Still made a nice profit, but it is frustrating to understand the cause.
I'm not getting a warm fuzzy after this presentation. The cherry picking comments used to be a little far fetching but this time it is blatantly obvious they withheld material information. They have the results and no trades should be made based of that information. I am encouraged by the little bit of information we recieved, but it does not paint the whole picture.
They should no longer be able to post this message. They have results from this study, but they have not shared them. Repeating this information and withholding results of this trial is misleading, regardless of note about animal model. This leads investors to believe that the drug is capable of inducing motor recovery.
About ANAVEX®2-73 (blarcamesine)
ANAVEX®2-73 (blarcamesine) activates the Sigma-1 receptor (S1R) protein, which serves as a molecular chaperone and functional modulator involved in restoring homeostasis. In a Phase 2a Alzheimer’s disease (AD) study, ANAVEX®2-73 (blarcamesine) has shown dose dependent improvement in exploratory endpoints of cognition (MMSE) and activities of daily living (ADCS-ADL). Full genomic analysis of ANAVEX®2-73 (blarcamesine) Phase 2a study in AD patients was performed. The ANAVEX®2-73 (blarcamesine) Phase 2 PDD study design includes genomic biomarkers identified in the ANAVEX®2-73 (blarcamesine) Phase 2a AD study. Studies of ANAVEX®2-73 (blarcamesine) in a disease modifying animal model of Parkinson’s disease indicates that ANAVEX®2-73 (blarcamesine) is well tolerated, induces significant motor recovery (p<0.05), induces neurohistological restoration (p<0.05) and reduces microglial activation (p<0.05), a potential biomarker of Parkinson’s disease. Behavioral patterns were completely normal, meaning no signs of either dystonia or stereotypic behaviors were detected in animals receiving the treatment. These studies were funded by The Michael J. Fox Foundation for Parkinson’s Research.
Does that mean we should sell AVXL?
This is why Anavex loses credibility with so many investors. Present the findings of the study, period.
Primary Outcome Measures :
Cognitive Drug Research (CDR) Computerized Assessment System Continuity of Attention [ Time Frame: 14 weeks ]
Change from Baseline to End of Treatment in Continuity of Attention as measured by Cognitive Drug Research (CDR) Computerized Assessment System Continuity of Attention test
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 14 weeks ]
Assess the safety and tolerability of ANAVEX2-73 compared to placebo
Secondary Outcome Measures :
MDS-UPDRS Part III Total Score (Motor Scores) [ Time Frame: 14 weeks ]
Change from baseline to End of Treatment as measured by MDS-UPDRS Part III Total Score (Motor Scores)
SDS-CL-25 [ Time Frame: 14 weeks ]
Incidence of sleep disorders symptoms (SDS-CL-25)
I understand this was an alzhiemers conference, but withholding information causes trust issues. The study was complete, present all of the results. I'm sure the FDA will want to see all of the data... why can't investors?
Because our market cap is ridiculously low even using the casino valuation method. People buy-in for a lottery ticket.
Think thiers will be complete before Anavex?
Weren't they testing for motor function as well?
How much debt does Anavex have?
How about just eliminating side effects. Even if it performs the same, but is safe and tolerable with no side effects, which would doctors and patients prefer?
Sleep?
Let's add epilepsy, MS, ALS, HD and a couple more. Of course it would be good to generate some revenue first.
They are quite different though, and that is why I believe A3-71 will be more effective with alzheimers than A2-73.
adverse cholinergic responses attributed to activation of peripheral M2 and M3 mAChRs
s1 agonist (IC50 = 860 nM); also displays affinity for muscarinic M1-M4 receptors (Ki values < 500 nM), but not for s2 receptors
Anti-amnesic and neuroprotective potentials
of the mixed muscarinic receptor/sigma1 (p1)
ligand ANAVEX2-73, a novel
aminotetrahydrofuran derivative
It is very encouraging. Can't wait for the results.
What information are you looking for? Information about Skarpelos?
Ha, you may have been the one that pointed me to CTIX, because of your name. I did a little research and jumped in based on potential hype. Got out after an easy double and never looked back. Easy $10k in profit. I used to post as pivotalchange on the aforementioned board. There were some interesting conversations. I remember I particular the discussion about brain waves and Kanta? from seeking alpha. Oh the energy this stock had then. There was definitely a synergy in the stock until some people conflated scientific information with negative hype. People began to question what was hype and what was not. There is no doubt the company was trying to raise money... 10 million shares to... where are we now? That was also the time when biotech investment started to take a turn on future valuations. Even now I think we are a tad undervalued.
I agree, but probably not the same way wholistically.
I invest in funds mostly, but prior to the housing bust I realized that most funds don't account for changing market conditions. I decided to mix things up with stock and after trading any where from 1-6 different stocks and holding a day job, I realized trading in 1-3 is easier to manage, with funds as a core. Just too much information to watch if you are investing high risk. You start to become familiar with the MM moves and social sentiment where you can trade off of that. There is no exact science that can predict the moves, but fundamentals can set the direction if you stick to them. I've made alot and lost alot, but on average have done well. I sold quite a bit prior to the first pop of AVXL, lessons learned from PRAN. I've made quite a bit off of hype. If you are young, taking risk can be rewarding and if you fail you have time to make it up. Don't risk what you can't lose. 100,000 shares at .36 is only a $36,000 investment. Now with 40,000 after shaving some profits, it is almost $240,000 after 6 years, or roughly 95% yearly. If i would have been safer on the pops I would have several times more than this. This doesn't accout for the amount I pulled out of the stock, but you can get the idea. Time will tell if I will make the right decision. Missling has removed the binary factor of AVXL, however, many will trade that way to the downside. I started investing when I was 21. Kinda old to get started, but definitely young enough to make mistakes. Like I mentioned I researched probably hundreds of scientific articles, reading 3-10 a week, and looking for the right criteria for an undervalued company. When I was in high school I did some work for a CEO of a large, well known company. He offered up that if I should invest $30,000 in some company called Qualcomm. I thought, that is preposterous, but he explained he would not accept anything less and that it takes money to make money. I could have found the money and I could have lost the money at that age. I worked hard then, but I didn't make my money work hard for me. I'm not wealthy and won't pretend to be. AVXL has the potential to be a life changer for me, but I can't loose sight of reality.
I dont know if this post will get deleted too. Seems on topic... I used to follow "Hot Copper" in the PRAN days. It was my first major disappointment, but due to timing it had my investment over AVXL. After reading hundreds of scientific articles I settled on two small cap companies with an upstream mechanism that seemed much more logical that the current prospects going fo the after effects. What really got my attention was the work of Dr Abraham Fisher and AF710b. There was overlap with PRAN with Dr. Tangui Maurice. The similarities of the Fisher's work and Dr. Alexandre Vamvakides was intriguing, particularly from the size of the molecule and use of muscarinic receptors. I still believe there will be benefit, and I believe a3-71 may be more effective in relation to Alzheimers, but maybe not so much for other diseases. A2-73 seems more of a wholistic medicine in my opinion. I guess the clinical trials will shake this out.
Nice! I accumulated around 100,000 pre-split with a cost basis around .36. I've traded in and out post reverse split and have owned anywhere from 25,000-80,000 shares. I've pretty much settled on 40,000. Seems about right for a lottery ticket, although I'm getting older now and don't have as much patience.
I recall it being a Nevada based printshop shell owned by two bothers and a ?? Board. Wonder if the brothers still own stock, haven't really looked into it.
A2-73 approval would be great news for Anavex!!!
Looks like Rivastigmine has a monthly cost of around $474. Just for comparison. I'm not familiar enough to know what thier target market is.
Primary Outcome Measures :
Cognitive Drug Research (CDR) Computerized Assessment System Continuity of Attention [ Time Frame: 14 weeks ]
Change from Baseline to End of Treatment in Continuity of Attention as measured by Cognitive Drug Research (CDR) Computerized Assessment System Continuity of Attention test
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 14 weeks ]
Assess the safety and tolerability of ANAVEX2-73 compared to placebo
Secondary Outcome Measures :
MDS-UPDRS Part III Total Score (Motor Scores) [ Time Frame: 14 weeks ]
Change from baseline to End of Treatment as measured by MDS-UPDRS Part III Total Score (Motor Scores)
SDS-CL-25 [ Time Frame: 14 weeks ]
Incidence of sleep disorders symptoms (SDS-CL-25)
https://n.neurology.org/content/65/10/1654
What percentage of alzheimers patients have the markers Anavex has targeted for efficacy? What is the Anavex alzheimers market.
When is Rhett data coming?
Great job Missling! You let everyone know the material information and now they can chose to listen or not.
Sounds like this party is coming to an end. I believe the endpoints were defined. This isn't exactly something you could fake and get away with it. Jail or sail.
The results show clinically meaningful, dose-dependent, and statistically significant improvements in the Cognitive Drug Research (CDR) computerized assessment system analysis.
The CDR system is a computer based cognitive testing tool, developed to assess both enhancement and impairment of human cognitive performance. The CDR system's simplicity, sensitivity and specificity makes it acceptable to be used in clinical trials with either healthy subjects or diseased patient populations.
Wow. Can't even top 52 week high on great news. Our market is amazing.
Thanks to Steady, Boi and Bio. I appreciate the conversation. While I think this scenario could be run out further, I don't believe that Missling is sitting on material information.
The rule states "buy or sell" based on the information. Naked shorting is illegal, so this type of trade is irrelevant. Certainly you can be a security holder and hedge your position. Selectively withholding information and making decisions based on that material information without disclosure is wreckless.
Rule 100(b)(1) enumerates four categories of persons to whom selective disclosure may not be made absent a specified exclusion. The first three are securities market professionals -- (1) broker-dealers and their associated persons, (2) investment advisers, certain institutional investment managers24 and their associated persons, and (3) investment companies, hedge funds,25 and affiliated persons.26 These categories will include sell-side analysts, many buy-side analysts, large institutional investment managers, and other market professionals who may be likely to trade on the basis of selectively disclosed information. The fourth category of person included in Rule 100(b)(1) is any holder of the issuer's securities, under circumstances in which it is reasonably foreseeable that such person would purchase or sell securities on the basis of the information. Thus, as a whole, Rule 100(b)(1) will cover the types of persons most likely to be the recipients of improper selective disclosure, but should not cover persons who are engaged in ordinary-course business communications with the issuer, or interfere with disclosures to the media or communications to government agencies.27
He can certainly review the data as long as he wants as long as he makes no material decisions based on the information and no one else does either. Certainly there is insider trading that can happen regarding forward looking plans and statements, but not on material information. Withholding information and making decisions to increase stock value based on that information could certainly bring damage to someone that is short.
I don't think your statement about disclosure is entirely true. Damage can certainly be realized from withholding good news. This market works both ways. Material is material. Withholding any information that would significantly influence the value of the organization would be wrong, especially if the news were to leak to some and not others.
Are we on the 5th or 6th trial started now without announcing any results? We should start a couple this fall for epilepsy and MS. Then do extensions of those too. Then we could extend the 5 or 6 trials we have underway for about 5 years so we can see the effects. Then we should go after other markets, just to be sure before we wrap these up before announcing anything. Then when we are near completion of the extension trials and have alot of information that suggests the drug could be successful, we could probably do one more trial for sleep, before announcing final results. In all with extensions, we could probably break the record for the number of active trials by one company without any sales.
I'm not being nice. Need morning coffee. Good luck all.
There is reasonable evidence to conclude that the drug is safe and tolerable. There is some inconclusive evidence that the drug will provide benefit to some patients, but there is not enough information to conclude with statistical significance that the drug will provide benefit to a specifically defined population. SAS is not near the clinical significance of a successful P3 trial.
I think of it like this... Anavex paid the entry fees to the poker tournament and has made it to the final round. The SAS is like peeking at your hand and realizing you have a pair of Kings. There is a higher chance of winning that hand, but in the end, peeking only let you know you have a pair of Kings. You tell me if a pair of Kings is going to win that hand and if the action of peaking contributed to the win any more than waiting for the cards to be shown.
Those were my thoughts. The segregation I was referring to between groups 4 and 5 was from WT S1R and not, which meant they could have APOE3 allele.
I would not interpret that way... exactly. There is a split between group 4 and 5 that creates 2 distinctive groups. So for for groups 5 and 6 I couldn't tell if any of them have APOE3 alleles. Additionally, did any of the 5 additional patients in group 4 have a high concentration of A2-73?
In terms of benefit... there is no placebo control. If the SoC were considered to provide any benefit at that point, at least there would be a measuring stick.