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Just how toxic LPC turns out for Anavex remains to be seen. If, it is of course not a given, we end up running the 3 trial on LPC financial and grants to ultimate approval of one or more of them. Could it be some will change their mind?
Agree, suspect our collective minds are in overdrive to fit the lack of information to exotic theories.
I will accept the idea that the Plus Patent firmly in hand is a dependency for potentially interesting news.
Also fair to assume the Sept 11 event is of some significance.
Thanks! I re-sent my email a little while ago hoping it will reach the destination this time.
Theories on this board about just about everything
Having an email address published on the website and then bouncing emails to it, not professional is it?
More likely just a short term glitch.
Gave up on their website message facility as it seems to be very restrictive on message length.
Glad to hear IR is still alive. My email to ir@anavex.com yesterday bounced.
Hmm,
Just receive this Failure Notice from my email provider:
Yeah I'd say zero before long! Missling et al are deliberately and repeatedly stating that Anavex have 3 trials starting this year with read out in 2018, all because they love lawsuits, ruined reputations and the prospect of some time off.
No surprise! Very few, I would think, expected a talk by Macfarlane without any preceding PR from Anavex to reveal anything new.
What is your guess the claim of such a lawsuit would be?
In that case I was one of thieves
And what do you know?
A likely answer could be that the SAB members are aware of the extension data. Even if the data is not indisputably superior, but has promise, there may be enough incentive to join.
There are no doubt many biotechs with somewhat questionable data that still attract SAB members where they mutually see some chance of navigating towards a drug approval, which may ultimately fail, but allow for warrants or options to pay out along the way. However respectable a SAB member may be, it can of course be no guarantee of eventual drug approval.
Lastly, the extension data may in fact look out of this world hitherto unseen great. Just a matter of time before investors, traders, shorts, patients and the world at large get to know all for good reason that will become clear.
We have not seen negative news, we have had no news and share price bleeds. Rationally, if one was long yesterday because of the science, SAB and so, then it would also be rational to buy more stock at these prices?
Ok F1ash, you have finnaly compelled me to ask some questions of Anavex IR:
I suspect Anavex needs a certain amount of cash in order to press the start button on trials.
Back in March the company failed to obtain enough votes for Authorization of up to 10,000,000 Shares of Blank-Check Preferred Stock in General.
Whatever and whomever these 10,000,000 shares, or proportion thereof, were intended for we do not specifically know. It may well have been something that would have seen the trials on their way by now and on which the company had based the early 2017 trial start statements that we read in the Caulfield/Alfred Health end of 2016 report etc.
This has left Anavex with LPC as the only self-funding option, which as we seem to be observing leads to a no news slow bleed stock price situation.
Who the hell voted no???
It could be that along with the PK/PD data we will get a more elaborate PR including a discussion of the 18 month data etc. That to me would make more sense than standalone raw PK/PD data.
For what ever reason the time is not yet right to release that information.
We will see, but hard to imagine with the repeated assurances of good things to come that the company is having us on and things are really not looking so good - don't you think?
I suspect it is more important to reach the funds required and focusing on getting off the starting blocks.
The dilution diff between 4 or say 6 dollars won't matter in the long run, so long as the trial results are good.
True, thanks!
F1ash, completely agree.
Regardless of our various attempts to estimate the number and prices of shares issued to LPC, the upshot of it all is of course positive.
I'd much rather have Missling's skillful navigation to fund the trials cheaply now with minimum dilution, than giving away the company's soul and a sizeable lump of the business to some BP partner.
A partner for marketing and distribution once we have an approved drug and corresponding value is, as I've heard Missling, always been the plan.
Suddenly catching you off guard.
the Q2 report out of the way today, could be clearing the way for follow on PR tomorrow.
Also I see this as significant confirmation of the expectations and interpretation some of us have voiced.
Q2 report out. Nothing new, but again the clearest possible confirmation that PK/PD will be released next followed by the initiation of our 3 trials. Only bit I will give some of the sceptics here is the possibility of read out in 2018, no longer in 2017.
And do believe he described the AD p2 trial had been designed likewise referring to P2/3 must be confirmatory with best likelihood of success. Anything else, in Missling's view would be unethical!
I believe Missling said that in connection with AD, but the same approach will likely apply to all 3 planned trials.
Anyone investing in biotech, and in life generally, should allow nagging doubts their rightful place in evaluating and acting on information.
Things are not always as they appear. Many things contested and argued about Anavex certainly forces me to reinterpret my own conclusions.
In executing a biotech investment strategy, I for one consider Anavex one of the current top contenders for a place in my portfolio for risk/reward ratio - sounds to me like it does for you also.
At least for some time now the Anavex critical review has graduated from corner printing shop turned biotech and Nell Rebow's qualities, so things are still moving along.
Meanwhile, I'm prepared for the real possibility that my assessment turns out wrong.
Indeed one assumes Missling's increasing enthusiasm and convection originates in his insights to the by now extended datasets and analysis, not clasping for faint nuggets of potential efficacy trying to keep Anavex a going concern.
Perhaps, but still unlikely unless LPC are sitting on the shares they are being issued. Otherwise if offloaded in the open market those shares would have, I think, contributed to a significant increase in trading volume.
We won't really know what has been going on until we see the Q10, but it is useful to kick the scenarios around.
Not sure that last paragraph would have done much difference with the meagre daily trading volume we have witnessed.
Try the maths and let us know?
Exactly Polarbear, thank you for taking the trouble to list exactly what Missling has said regarding dose response and correlation to other measures.
When answering Froll, I was assuming everyone INVESTED here have done their DD.
I must say Missling, to my ear, have stated these points with increasing enthusiasm over the last few presentations we have seen. I don't expect he is doing that contemplating class action or worse while speaking!
Getting late for me.
And it should be 40 business days, whereas 55 is the calendar days.
So 20 * 50,000 = 1,000,000 shares [7.3% of period volume] * avg. price $5.0431 = $5M.
No one has pulled me up on my error, so I'll do it (as I should).
I said $50,000 every other day, when in fact it is 50,000 shares.
So the calculation based on utilising the LPC facility fully is; 27 trading days * 50,000 shares = 1,350,000 shares. Which at the period average price per share of $5.0431 would raise $6.8M for Anavex.
This would corresponds to about 10% of the periods 13,540,838 shares trading volume.
So still, this does not seem a massive influence on proceedings.
Yes, that would be the drive of any Biotech, so long as they see some sliver of potential drug effect.
But, as has been debated (a lot) here, somewhat unusual, the PK/PD data has been listed by the company as an explicit catalyst up next. I just can't help, but think they are doing that because they really want to show a beautiful dose response curve at least for an identifiable subgroup, whence the time is right...but, I'd admit this notion may belong to the daydreaming category.
This makes a lot of sense!
When I contemplate what you state, the one thing that I keep coming back to in my mind is that; Anavex have repeatedly in writing, in interviews and in presentations stated that 3 trials will be initiated within 2017.
I think we all agree that the PK stuff, and whatever Ariana is doing with it, is a prerequisite for trial design and FDA go ahead.
Making firm and repeated statements on the 3 trials kicking off this year, one would strongly assume is not being done on a wing and a prayer, but rather some further post 5 week confirmation of dose response?
We do know that an S3 EFFECT was files with SEC 12th June 2017.
With disclaimers for me being in error it could mean as follows:
Since then there have been 55 business days, where every other day LPC can be asked to purchase $50,000 worth of shares from Anavex.
I should add, that if so altogether dilution would be much less than having to give away business to an earlier stage partner. So in the end the LPC dilution that folks seems worried about would have all but evaporated.
Could it simply be that over time on average using up the LPC agreement will yield a 'fair' per share price? All given of course that soon PR will significantly lift the PPS.
With that funding in the bag, Anavex will be able complete the AD P2/3 trial on their own and only engage with a partner at the marketing stage - at least that is what I think I've heard Missling say.
Perhaps the timing of the quarterly report and Macfarlane's Rotary presentation is no co-incidence.
The reason behind "Breakthrough" may be PR'ed by Anavex just ahead of Macfarlane's show. Allowing Macfarlane the stage with a native crowd to speak of his involvement and outcomes with A2-73 could be a nice gesture of appreciation from Missling?
All just guess work and hope on my part, you understand.
And I give it some importance that Missling's, even more so of late, has been explicit about the various measures correlating towards positive action of A2-73.
I think so. Pivotal and Confirmatory trial are interchangeable terms.
I agreed what we have been through so far is a P2 part a and b, plus now the 104 week c extension trial incl. EXPLORATORY efficacy with UNEXPECTED therapeutic response. Soon, we expect, to be followed by P2/3, which most probably means a P2B trial transitioning to the confirmatory P3 trial with adaptive protocol.
We shall see hopefully quite soon...
He has however referred to the next trial in AD as "confirmatory".
Highly plausible I'd say!