I totally agree with you—as a CEO, assume nothing.

Enrollment is not dosing a patient. It is merely an indication that a patient has met the criteria to begin dosing once the trial has started. Are you suggesting these trials have started dosing and the company hasn’t PR’d it? I think the reality is they do not have the pool of 450 patients needed yet to begin the trial. Why would you start dosing some patients when you don’t even have enough patients yet to run the trial? THAT makes no sense.

On a similar note, why does it seem like as SH we always have to speculate what is going on behind the scenes in this company? I’m not buying the “protecting our trade secrets & IP” angle.

$2.50 a share says it all.

Bourbon:

Three trials up and running?

Enrolling yes, dosing no.

You can only get readouts when the dosing actually begins.

Don't hold you breath.

Jonjones325:

I definitely sense frustration on your end. You were so positive after attending the Annual Meeting in April. At that time, you said that Missling seemed to have all the right answers, and you left feeling bullish about the company's future prospects. You even wrote a very enlightening post about this meeting, and many on the board appreciated your insights.

Fast forward 6 months, and from a shareholder's point of view, the SP is just woeful. Everything that Missling has said will happen seems to be taking much longer to materialize. The remark about Rett being started "after the holidays because things tend to slow down" or something to that effect was puzzling--even aggravating.

You raise valid points--if DM is so altruistic and really wants to help those suffering with these CNS diseases, why does it seem to be taking so damn long? Some of the options you mention seem plausible--if not more sensible--if he was truly motivated by altruism.

This CEO & company really make you wonder if they really know what they are doing, OR are they just making it up as they go along. Should we really be surprised that institutions are not a larger percentage of stock ownership, given the missteps and delays of the company?

Any idea when the quarterly results will be released?

I thought that would be this week, but I guess not.

Anyone?

Spoke too soon, Benny. We’re back in the red.

SOS, different day.

“Something must be coming.”

I think we should be getting a PR about a quarterly report. The SP is already retreating, so the early morning increase seems to be short lived.

Just another uneventful day being an AVXL shareholder!

One?

I count 3 (AZ, PDD, & Rett).

I’m not “spinning” anything. Facts are facts.

Let’s hope DM has learned from his missteps. Enrollment is not the same as dosing, so my confidence level is not very high.

Maui:
However long it SHOULD take vs how long it WILL take are two completely different time frames. This company’s track record of meeting milestones dictates to at least double the stated timeframe from DM.

If DM says there will be a RETT & PDD readout in 2Q 2019, that most likely means we’ll be getting the results in 2020.

Welcome to Anavex, where senior management over promises and under delivers.

“We are entering the holiday period so preparation will likely slow down”

That is an unfortunate reason for why this trial may not start by the end of this year. So, we write off November, December, and early January due to holidays, July & August for summer vacations. The only problem here is Rett, ALZ, & PDD take none of these breaks on the people afflicted with these conditions.

And we wonder why AVXL is at $2.50?

Haven’t we been saying there is an imminent partnership for the past 3+ years? This is where I question the competence of our CEO. Let’s just say the MS indication is a possible partnership opportunity with BIIB, why not monetize that so we could use this capital influx to fund the AZ, PDD, & Rett indications? This is where the company wants to focus its efforts, so why not broker a deal?

Maybe there is no deal because the other party is not interested.

4 to 5 months to start the Rett trial?

And we wonder why the SP is where it is? The cabal seems to be our company’s management.

Bio4:

I think you make a good point—tax loss selling is likely to put downward pressure on the SP for the remainder of 2018 unless DM pulls a rabbit out of his hat. I’d welcome a partnership at this point, since it would bring in much needed capital, as well as another CEO’s oversight into the process.

Haven’t we been saying this for 3 years?

Xena:

The company has enrolled the first (which I interpret to mean ONE) patient thus far. Unless my interpretation is wrong?

They have to enroll 120.

Seems to me this is going to take some time?

AZ announced the first patient enrollment nearly 2 months ago, and as far as I'm aware, the trial has yet to start because they need another 449 more patients.

I hope you're right and I'm wrong.

Simonizer:

As Jonjones has stated, and which I agree, the past 3 years of presentations and earnings conference calls have done next to nothing. The upcoming trials are what determines the success/failure of this company, and based upon how long enrollment seems to be taking, we will be waiting longer than previously hoped for readouts.

Have you listened to the recent conference calls? If not, go back and give a listen. They generally last about 20 minutes, of which the first 5 minutes are a restatement of the Safe Harbor language. That leaves about 15 minutes. There are 2 analyst questions, and it's usually the same 2 analysts asking pre-screened meatball questions.

Maybe this time it'll be different, but I wouldn't bet on it.

Jonjones:

It does appear that the SP is "stuck in the mud" until the next binary event, which could be AT LEAST 6 months out (possibly Rett readout?)

It doesn't help that we are starting (correction: enrolling) PDD & AZ at a snail's pace.

The more time this takes, the more money it costs. And time is not a luxury this company has.

Fingers crossed.

Basparks79:

I sure hope you're correct. You have not once wavered in your conviction, so I respect your loyalty and commitment. It sure would be nice to start to see some kind of modest SP appreciation for 3+ years of loyalty (maybe $5 per share)?

I do think DM is finally starting to get the plane moving for takeoff. I just hope he has enough runway (money) to get airborne.

The only problem with this hypothesis/belief that only "weak hands" are selling is that this has been going on for several years. Assuming an average of 200K shares trade each day, that is 4 million shares each month. Being there are 40 million plus shares O/S, the "ownership" of this stop has presumably "turned over" at least twice.

That's a lot of weak hands!

I would temper your expectations regarding Dr. Hampel's presentation--and the perceived effect it may have on near term SP. I really don't think this will move the needle. Perhaps it may garner some attention to the company that would otherwise not be there, but I don't think this will have any material impact near term.

I am VERY excited about Rett, and am grateful that DM persevered to finally gain the FDA's approval--albeit with a limited sized trial initially.

We seem to be heading in a positive direction. Now we just need to get these trials fully enrolled and begin dosing. Easier said than done, but time is money.

Congratulations, Anavex!

This is a significant milestone.

Well done.

Not only are the "drop outs" relatively high (6 out of 27 is a 22% rate--not inconsequential by any measure), but even Dr. Missling's statistical analysis goes against conventional wisdom. He commented earlier in the year that statistical significance can be achieved with data from 3 patients. I'm not sure most statisticians would agree with this statement. Dr. Missling seems to be making up things as he goes along--the problem is the establishment either views him as a maverick, crazy, or incompetent. Which one is correct remains to be determined.

I don't want to burst any bubbles here, because I have PLENTY of skin in this game as well. However, if you/"we" are thinking CTAD will be the event that moves the needle, prepare to be disappointed. I think most in the scientifick community have already dismissed the 3 year study that was done as being "inconclusive" at best. It's time to "move on" and get this 450 patient study going in AZ & PD as soon as possible--no sense looking back or dwelling on the past. That ship has already sailed, and the boarding ticket is $2.44 per share. Let's hope the next destination will require a boarding ticket well north of $10.

Would love to hear about a Rett start, but I'm starting to lose faith in that--despite DM's recent assertion that it will happen soon. What does soon mean to him? 1 year, 3 years?

Haven't we been hearing this for the past 3 years?

...they're (the cabal, the cesspool) lowering the share price so they can buy "cheap shares" before the AAIC, CTAD, Investor Conference Calls, FDA New Regulation Disclosures, Healthcare Conferences....

too bad none of these events has done a damn thing to move the share price in a positive manner for any prolonged period of time.

15 Minutes?

Just out of curiosity, does anyone else feel that 15 minutes is hardly an adequate amount of time for AVXL (or any company) to adequately present data, explain their interpretation of the results, and field questions from audience members who wish to share a thought/observation/question?

Nearly three years of "longitudinal data" of AZ comes down to 15 minutes...seems a bit absurd to me. Why is more time not allotted at these conferences, especially for "late-breaking" data?

Oh well, let's hope DM & esteemed members representing the study can make a compelling case in that minuscule amount of time.

Meanwhile, looking ahead, how are we doing with enrolling/dosing the AZ & PD studies? Rett trial status?

It sure would be nice to get some news/updates about these trials soon.

If everything that worked in murines also worked as effectively in humans, we'd have a lot more drugs available to treat CNS conditions. There are plenty of studies that are done on murines that seem promising, only to fall well short in human testing.

As a person with a scientific background, you should also know that what may work well in a laboratory on mice and rats often does not translate as well in humans.

Thus the need for human trial testing, which is where many of these drugs then fail.

Theoretical to applicable in CNS remains the most difficult to prove efficacy in homo sapien testing.

I'm still hoping for a grand slam HR here (AZ), but would be satisfied with a double (PD), or a single (Rett). Anything that can help some of these poor suffering people would make me feel awesome, and would also help the validity of this baby biotech.

But we still have to see irrefutable results in humans, not just murines.

So we have a hearsay interpretation of a supposed IR statement to start the weekend when the stock is down?

And when exactly has the stock been UP for any prolonged period of time these past 3 years?

I'm inclined to believe that based upon this company's past performance, whatever time frame Missling gives should AT LEAST be doubled.

I'd love to be an optimist regarding this company, but at some point being realistic has to enter the discussion as well.

If this company continues to flounder into December without anything of consequence to announce, the tax loss selling will be significant.

Our CEO either seems clueless or detached from the primary stakeholders in this company--its shareholders. His quarterly conference calls are a joke, and the unwillingness of him to field "real" questions from people other than those that have been preselected is a major concern as well.

We have ENROLLED one person in 2 months? What a joke! I thought DM was committed to this cause, since his own family has suffered loss from AD. Where is the urgency?!!

Hmmmmm....so if it takes one year to enroll and begin dosing, another year to run the trial, and 6 additional months before top line data can be collected, analyzed, and interpreted, then we have a problem.

That's 2.5 years.

We have, in DM's estimation, enough money for 2 years.

We'll run out of money.

Isn't our CEO supposed to be a financial genius?

I really hope we have someone with pockets willing to partner, because I don't think Missling is capable of getting this done. Maybe he believes his own hype, but noone outside this message board is too impressed.

JMHO.

How will I know the day before? I wouldn't-but you asked when I'd like to buy AVXL.

Ideally, I would like to buy it right before a major news event were announced. Since I don't know when such a date will be, I continue to hold onto it (for 3 years, in fact), in the hopes that we'll "catch lightning in a bottle."

I have my bottle ready to go, I just need the lightning strike.

I'd want to buy the stock on the day before they were to announce the FDA's approval to the start of the Rett trial.

I remain skeptical of TA, but if it works for you, then more power to you. I think TA is more applicable to cyclical stocks.

I remain committed to the notion that biotechnology is a news event-driven sector.

I think you're being very kind.

Your last 3 words are profound regarding TA: "charts are useless."

So let me get this straight: $2.50 is really important, unless it drops below that level, in which case, $2.00 comes into play. Now, it might go lower, or, it might just rally.

Maybe we should just ask the Long Island Medium lady what the stock price is going to be. Forget that--how about the 5 numbers and powerball in this weekend's drawing?

So much for predictions, right?

Maybe if we compared AVXL’s stock decline to the Bitcoin sector over the past 6 months, we’d feel better.

Take any 6 month period of time over the past 3 years and you will see the irrefutable—the stock has performed DREADFULLY. Why would someone imvest in this stock today when most likely tomorrow or next week it’ll be lower?

First, I want to refute a notion that is very prevalent on this board regarding the company having “no debt” on their BS. I would counter that this is because a company that lacks ANY predictable revenue stream (grants & government funding are not predictable), would very rarely have debt, since they would have no revenue stream to repay the debt. They might use convertible debt, but even that usually carries an exorbitant discount rate.

Second, the more the SH price erodes, the more likely it becomes that DM will take out the Finance 101 playbook and do another reverse split to “reconstitute” the SP to a more “investment grade” level. So to all those who don’t seem to care that the SP continues to decline, be careful what you wish for.

While I understand the big return that may await this stock likely remains several years away, the -3% per day is becoming an all too familiar occurence.

I apologize for my sentiment, but that is what 3+ years will do to one’s psyche.

Xena:

I want you (and us) to be right on this one so much that it actually hurts to see this one just trickle away almost each and every day these past 7 weeks.

We will either be the smartest investors or the biggest fools. I don’t think they’ll be a middle road on this one.

LMAO all you want, but my cost basis on AXON is a mere $2.75.

I hope both AXON & AVXL ate ultimately successful, because that means they are helping CNS patients.

WolfoMia:

At least one of my holdings in the CNS space is having a good day. AXON is "rallying" by 20 cents, or almost 9%. Not really sure why, other than they announced a few investor conferences they'll be attending.

I would really like to see AVXL have a day where it's up by that amount or %. It seems like those days have been few and far between.

Lima:

Yes, IR/SH relations are pretty much useless and biased. Annual reports also are a waste, with the exception being the financial statements and footnotes.

Regardless of what many say on the board, the price action (or lack thereof) is a concern. No matter if the market is up (which it has been) or down (which it inevitably will be), the trajectory of this stock is unmistakable. I don't need TA to highlight what is obvious to anyone who has owned this stock past a year (and I'm on year 3).

A rising tide (market) lifts all boats (stocks), except if you are an AVXL shareholder, in which case you wait for icebergs.

Last week I spoke to IR. They advised all is well, and everyone looking forward to the trials.

Did you expect to hear anything other than that? I'm glad to also hear that they're "trying to get the Rett Trial going with early approval if possible." Despite all of this, the stock continues to sink like the Titanic.

Ship captains, and CEOs, must be careful with icebergs!

I think your analysis is interesting, and the reaction of the market seems to align with your thought process.

BTW, I meant to state “respectfully”, not respectively in my previous post.

I do not believe anything will move SP

I will respectively disagree. If the Rett trial start were to get FDA approval, I am fairly confident the stock would rally to $5.

The FDA remains the "Good Housekeeping" stamp of approval, regardless of what others on this board may perceive. The FDA is still the gold standard--like it or not.