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AXON and NTRP are trying to squeeze efficacy out someone else's drugs that previously failed and have nasty side effects. VTVT, which I also hold in my portfolio is interesting, not least for their diabetes efforts. The market cap of vTv is just about $50M again back in compliance with NASDAQ listing rules and sure to dilute probably several times.
I haven't check, but are also berating those companies on message boards or is it a special treat for AVXL?
My original point was to look at what forward looking statements we have heard and check if any of them had turned out false yet. Have they?
You and others may be right that we have a lemon on our hands - only time will tell, unless of cause some here may be in possession of insider information.
The speculation here is enjoyable fun join and sometimes quite exuberant and even silly.
On the whole I am focusing on digging out stated facts and checking them. We are in a long period of waiting yes, but none of what the company has publicly stated can be said to have turned out false...yet.
That's all I am stating and is part of my kind of DD.
Missling in Washington twice leading up to the interview - what was discussed..,
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5504819/
If I understand this right, the HDAC inhibitor approach is not upstream of the actual cellular problems and decease modifying, like A2-73 Sig-1/Muscarin approach, and has side effect issues.
So maybe, just maybe, that is related to Biogen's shifting priorities...
Biogen remains an investor in the company, says Rosenberg, but dropped its buyout option after a “mutual agreement” driven by shifting priorities.
Worth reading this Oct 21, 2016 interview again for perspective.
https://www.sec.gov/Archives/edgar/data/1314052/000161577416007701/s104371_ex99-1.htm
An extract of stated facts in bold and my comments:
"SIGMACEPTOR Discovery Platform". Once one indication is hopefully proven...
"We will conduct the Phase 2/3 for Alzheimer’s." Did he know it will be P2/3 i.e. a P2 transitioning into a pivotal P3 on Oct 21, 2016 because of involvement with the Cures Act?
"Yes, we believe that sufficient financing in place and also because we are working with several foundations...". I believe Dr. M. means including LPC without saying so directly and of course how the company's fortunes and stock price may change with approval in a first indication.
Regarding Ariana: "patient stratification technology to potentially accelerate ANAVEX 2-73’s Phase 2/3 Alzheimer’s clinical development timelines". So we are waiting for it to go faster...seems a bit of a conundrum, but it may turn out to make sense...
About the Biogen MTA: "We are just providing the compound. After that, the evaluation will take place depending on what the findings are, and then discussions are expected to continue from that point on.". Hopefully deeper and more complicated discussions have been or is going on...and does Anavex owns the IP? "Yes, the company owns it."
"For larger markets like Alzheimer’s disease, partnerships for commercialization are very common.". Note "commercialization" i.e. post approval! "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."
"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.". The ODD trial being in Rett and one of the carefully selected members of the team being Dr. Fadiran.
As to what Missling is doing when not looking after his hair etc. "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.". Froll should be happy with this recognition, which of course is only the preserve of very few on this iHub board.
Which of these statements from Missling have yet turned out to be false?
MacFarlane's interpretation of the MMSE and ADCS-ADL graphs.
“The MMSE declined 45% less and the ADCS-ADL declined 56% less than what we would have expected from the historical control data,” Dr. Macfarlane said. “This is not only statistically significant, but clearly clinically meaningful for patients.”
http://www.mdedge.com/clinicalneurologynews/article/120066/alzheimers-cognition/sigma-1-agonist-presses-forward-after
God's gift to humanity? At the moment it feels more like investors gift to Missling.
It would be fantastic soon to read Anavex PR matching what Gottlieb has said here and you highlighted!
I would say the odds of that happening are worth the wait.
That's good to see, thank you. But, why not link from Rettsyndrome.org too?
This year.
Attila, that together with the hiring of Fadiran could well be pointing to a Master Protocol with a considerable number of trials across the many A2-73 indications we know about kicking of.
"Dr. Fadiran has an accomplished track record of working within the FDA,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. “His depth of experience makes him an excellent choice to manage the considerable number of regulatory filings that Anavex has planned"
Of course more trials means more funding required. Would be good to see that nut cracked with minimum dilution.
Minimum dilution though should be seen in perspective of the considerable revenue potential, if that is we end up with approval!
Just remember that once we see the first approval, likely in Rett, Anavex will become a revenue generating company.
I agree entirely with your sentiment. This logic is why I continue to be long, while also critically evaluating the alternative views. I just don't have the patience to write it all as well as you lay it out.
It would be a big blow to realise if in the end it turns out we have been duped and misled. If so, I will seriously consider dropping biotech investing.
Well perhaps. But keeping to facts we know that all 22 opted to remain in the first 52 weeks extension trial and, I think also the second 52 weeks extension.
Why, because there were no better options out there including SOC. I think that supports the idea that confidentiality is in place and hence we have heard no further.
At least I hope so.
I agree, a confidentiality agreement may well have been a condition for participating in the extension trial.
Also, there may not be many clues to help find the other 22.
But, one other possibility not to completely dismiss would be that some of them were located only to find that they did not do much different to natural history. In that case it would not be news worthy and thus a possible reason we have not heard more or seen leaks.
Agree, it is a key question that should puzzle the real investors here?
I could only think that patients etc. have told 'you speak you are out'!
Which, if true of course seems a positive. If A-2-73 has no real effect nor would a gagging order.
It would be good with more thoughts on this.
So at least three of the superesponders appeared on TV, but we have not heard word one from them. It is quite impressive really.
On a related note it appears that the rettsyndrometrial pre-screening website is not being promoted either from Rett Syndrome Org nor from the Anavex website.
Does that mean that parents and caregivers are not meant to know about it just yet?
It is only a couple of weeks ago that the pre-screening website for Rett patients was launched. Would the Rett org and Anavex agree to do that if they were not reasonably assured that approval for trial start is in hand?
It would be unethical to just string these girls and their families along without sight of FDA trial approval, would it not?
Rett trial will start this year! If not...
If one trust that, then it would be rational to expect the other two trials start this year too.
Does all that imply a common master protocol? Perhaps, but for that idea I have no concrete evidence from company communications.
Will be interesting to see how it all pans out. How far will the eventual trial start announcements and other potential PR push up share price and help limit dilution...
True, so we have an upper limit LPC dilution defined.
As F1ash points out, it seems very few, including those working hard to find negatives, read and record the information available in SEC filings and instead prefer to proliferate unfounded rubbish.
It makes you go hmmm!
61,864 on open @ 4.510.
Why would that not make any sense?
Followed by the usual small volume walk down.
The final dilution percentage from the LPC agreement we cannot calculate without knowing the future evolution of the Anavex share price. Consequently, even with honest maths, there is no way to know at this point how little or how much final dilution may be.
The LPC agreement per design will take time to drawn down, $50,000 worth of shares every other trading day, or more when PPS reach certain levels. We know that the first $24M took about 1 year to drawn down).
The hope and expectations of many here is that PPS will rise with significant PR well before all the funds have been raised through the LPC agreement.
As I said before, I believe the LPC agreement, and as we hope to see management strategy using it, will turn out to result in relatively lean dilution.
With your insights into Biotech, I would expect you to expect dilution.
Having said that in my opinion the LPC agreement and they way Anavex is using it may turn out to be a relatively moderate form a dilution compared some I have seen.
Anavex have $25M left to raise from the first $50M LPC prospectus still to draw down in full.
The LPC agreement further provides for another $50M, which like at the past AGM the company could ask shareholder to approve.
I submit that $100M plus existing cash as well as various government and foundation grants will cover the trials as stated by the company.
I base this opinion on facts stated by the company in PR and SEC filings.
So Seventh it was all dandy then, let's hope the other stock beginning with 'A' that we follow eventually goes the same way.
Agreed the rationale assumption has to be that data is at least ok and the silence has a reason to eventually be revealed.
I have tried and came up with equally lame ideas
Eh we have those 5 weeks, they were right at the beginning.
Yes and as far as I know it was the first time FDA management eventually overruled scientific opinion in favour of patients, parents and caregivers testimony in a very public way - it will probably be made into a Hollywood film one day.
It is possible, but if you read up on the Eteplersin story you will understand how this unique drama unfolded.
Ah ok, I was desperately trying to read the slides on my phone and they don't enlarge.
Don't think Sinking Alpha has had any influence on vtv's slide 9.
We have approval in 375 days?
Despite VtV currently running a large AD P3 trial and having a promising diabetes programme too, their market cap is less than half of Anavex's.
So not sure we can conclude that Anavex is being overlooked by the market based on trial size or stage.
Any other suggestions?
https://seekingalpha.com/article/4106591-vtv-therapeutics-vtvt-presents-rodman-and-renshaw-19th-annual-global-investment-conference
Slide 9, interesting how Anavex is not mentioned as just as unique as vTv with their RACE approach. Anavex being the only company with a Sig-1/Muscarin drug in clinical development.
Is that because they don't know about Anavex, they discount A2-73 as not being up there with the top programmes, or they are scared along with the rest of Alzheimer's hopefuls?
It may also be important to Anavex that with the new FDA rules patient and caregiver testimony could carry more weight than before raising prospects of approval without fully supportive data. A la what happened recently with the approval of Sarepta's Eteplersin for DMD.
I am hopeful for Alzheimer patients that you are right. But, in case the volatility of the super responder scores continue beyond 57 weeks, then it could also pull the average down. In my opinion we just don't know until we see the longitudinal data.
Of course the totally of data no doubt support the promised P2/3 trial. Regardless of exactly what the data turns out to be, I look forward trials starting.