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I am thinking that in practice the Parkison's pre-clinical studies funded by MJFF are complete.
The tick in box is likely awaiting the Tue, Nov. 14, 2017, 2:00 PM - 3:00 PM poster presentation by V. FRANCARDO et al. from Lund University Sweden.
http://www.abstractsonline.com/pp8/#!/4376/presentation/28724
It is possible that this pre-clinical study data has in the background is clearing the way for the promised PD P2 trial. Perhaps not with the FDA, but EMA the European Medicines Agency?
Do the TA gurus here think I'm in with a chance on my $4.03 stink bid today?
The Anavex website has also long been an issue regarding old information, some contradicting what we believe to be current status based on PR. E.g. the page concerning Anavex Plus, which fails to inform that the patent has been granted and the broken links on the pipeline page.
Looks like Axovant may be beginning a decline today. Taking profit before expected disappointing data?
According to the Anavex website pipeline Parkinson's is in progress at the pre-clinical stage.
Unfortunately all linking from the pipeline to more information is broken giving error 404.
Are they in process of updating?
I believe the reference is to the pre-clinical study already completed. Funding for a clinical study would be news.
I got in pre the up listing and reverse split. Sold some early with 200% profit, buying in again over time including 'trading' shares that I didn't trade . Average now 4.27.
Playing yes with some confidence, but won't be happy to see failure especially for patients and also not too much fun to see the investment fail.
Will probably take some profit on good PR.
A little experience and some luck. I don't always time my trades that well.
Not a trader or TA guy, 'just' an investor .
Nothing to disagree with in this post.
Got 1555 @ net 4.0339
For full disclosure long 65,420 shares, confident and prepared to take loss - so be it.
Yes there lies the answer. Publicly touting homoeostasis, dose dependent positive cognitive response etc., while knowing that in actual fact the results are quite the opposite would expose the company to class action lawsuits and SEC action.
Glad to hear it and yes it is a good unbiased post.
Perhaps one of us misunderstood the sentiment of Apostrophe's message?
I guess we have to wait and see. I am certain that is the only way you might change your mind and discourse.
3rd question. Answer, 2017 is not yet over!
The other 4 questions we do not have facts to elucidate (only more or less plausible explanations and conjectures helpful to consider risk/reward scenarios), but they will be understood once 3 is fulfilled.
If 3 is not finally answered this year, certainly cause for grave concern and acceptance of losses.
So is it time for yourself, Amatuer and others focusing their entire discourse here on concerns, to abandon your investments, if any in Anavex, now?
If not because, like I and I'm guessing most folks here, you find the risk/reward ratio rationally attractive - why spend all your posts here entirely on the negative side?
Seems to me more interesting to look at the balance of fact and concerns (so called red flags) as they evolve and dynamically attach some odds to the risk/reward ratio.
My own assessment is that the odds of at least 2 of the 3 trials repeatedly stated by the company to start this year actually will start with say 85% certainty.
If that turns out true everyone here, except perhaps for anyone who entered AVXL at around $14, are good and can reassess how to manage their investment for the new and very different scenario we would then be in.
3.45M priced at $7.25
Falconer,
Thank you for the explanation, which I couldn't say yesterday as I ran out of free posts trying to separate FACT from a mountain of FUD.
True, the actual cause or more likely causes of Alzheimer's are not fully understood.
Anavex claims homoeostasis and ability to stop protein missfolding, Aß and Tau tangles it appears and without nasty side effects. Hence my upstream nomenclature.
I do not claim to understand neuro-biology, but my layman's sense is just that I like what I read about A2-73 better than the HDAC approach. Maybe Biogen does too...(on a better informed basis than me)
I am saying that the story Amatuer was referring to was debunked as likely fake FUD by the link I provided.
Agree in the sense that genetics in general is as upstream as it gets. Just got the impression that the HDAC approach addresses a symptom downstream of the cause of Alzheimer's (based on genetics) that may be beneficial, but not disease modifying?
Btw. if you find yourself short on old FUD stories you could try the corner print shop again. There might a few folks around who haven't heard that before.
There is a good chance your reference is to a FUD story.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=116069551
Another MacFarlane exclamation.
http://www.360doc.com/content/17/0104/21/33008161_620104122.shtml
Steve Macfarlane, a professor at Monash University, who led the trial, exclaimed, "It is almost unprecedented for a new drug to achieve such a remarkable effect in early trials, and the state of the patient is 12 months ago Great improvement.
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.