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If your definition of soon is within the next 3 months, then all 3 trials will start soon. At least according to the company's repeated written assertions, the latest only 2 days ago.
Aside from partnership conjectures and buyouts, just hang on to the repeated fact that 3 trials will start this years including Alzheimer's.
Yes in principle that is true. But in the USA at least that would only happen after, is it 7 years, of FDA marketing exclusivity. By then 3-71 may have taken over and the patent you refer to approved or some other combo or even Anavex Plus itself been proven better than A2-73 standalone.
There may also be an out chance that generics of 2-73 could emerge in other markets that do not enjoy an FDA type exclusivity.
But I believe the bridges have been raised with the APlus patent and hence I say good enough!
Same as Corp. Presentation from March 2017, but in fact with less detail on rare diseases.
The likelihood of another potentially significant PR this week may keep the share price up.
Exciting times for sure!
It is tempting to hope that all the trials will be pivotal. But, that may be reading too much into the sentence.
Never mind the title, this is what matters:
intellectual property protection covering composition of matter for ANAVEX(TM) 2-73 directed to a novel and synergistic neuroprotective compound combined with donepezil
Again it can't be said clearer!
ANAVEX™ 2-73 is to advance this year into a Phase 2/3 clinical trial for the treatment of Alzheimer’s disease, as well as other neurodegenerative and neurodevelopmental CNS indications, including the orphan designation Rett syndrome.
Not sure if your request is meant sincerely, but I will oblige.
I do agree with Reyton's quote, which is very pertinent to an investor not least in biotech. Do thorough DD and stay the course unless it becomes clear that your reasons for holding have changed.
There seem to be a number of posters here bend on warning against investing in AVXL. Perhaps just genuine reminders that investing carry risk?
A simple first rule to counter these warnings, is the opportunity risk associated with not investing, in this case, in AVXL.
Without investment there can be no gain!
Worth considering with the catalyst lined up for AVXL. The next few PR's may well result in higher share price, but is no guarantee of ultimate success.
Personally, I will reassess my investment if and once we get meaningful rise in share price. Is it then time to secure profit, how much of the position to liquidate in an overall portfolio or of course if confidence in fact is further increased.
Still a small risk that the short term future could bring negative news, but in my humble opinion AVXL offers an attractive opportunity to gain.
First rule is: where there is no investment there can be no gain
That's a good engineer's analogy PeterKarol.
It would be in the scientific spirit for ffrol to provide a citation and reference to the sig1 research that demonstrates that other agonists are at least as good or better than A2-73 at inducing meaningful therapeutic response (even if previously provided).
Missling has repeatedly said that Alzheimer's is a complex disease, which is not yet fully understood. Likewise, MOA of A3-73 may not be fully understood and multiple approaches may be needed.
Only time and a larger trial will remove the doubt. We should also learn which patients and possible variants of dementia (incl. variations of what today is broadly labelled Alzheimer's ) the drug could help on. Hopefully we get a steer on that from the Ariana analysis.
I have noticed that in recent times the ask after market close often sits at exactly $6.29. Presumably some algo generated placeholder number.
Prevention is better than cure.
So called life-style diseases are massively on the rise, not least in countries where the much desired western life style comes along with economic growth.
Diabetes is just one of those diseases that could be drastically reduced through addressing the couch potato, pizza and coke culture.
But of course the economic interests seem to outweigh those clearly connected health concerns. The irresistible desire for sugar and fat generates billions of dollars in revenue for the food and pharma industry alike and the marketing folks understand that all too well.
As far as I understand Alzheimer's may also be to a large degree a life-style disease where the risk can be reduced through a sensible diet, exercise and by staying mentally and socially active.
Unfortunately I suspect there is a lot of interest at stake that would rather come up with medicines that allow more of us to live and spend more for longer.
I guess it is utopia to imagine that more health spend were place into education and prevention, and at the same time allowing dedicated focus on the many and varied diseases, say like Rett, were a biotech solution is desperately needed.
Glad to hear it, didn't sound like something Dr. M would say.
Exuberance for more buy outs triggered by Gilead's acquisition of Kite, I suspect.
"This Drug is a gift from God to humanity."
Just like Alzheimer's and everything else?
Slightly odd isn't it and seemingly reverse proportional to overall interest in the market.
M is not a founder, he is 'talent' incentivised to join the company early to shape it's future success (and risks) against a reward that presumably is commensurate with his market value. Not unusual at all - is it now?
And?
Nothing unusual for a young public listed company in biotech or otherwise.
Doubt sneaking up the longest and strongest?
$5 average
You would have thought everyone here would know that patent is in bag.
It was construed as FUD, but I have mentioned previously that Rett seems either a big gamble or well considered strategic risk taking with an understood likelihood of success.
Rationally we must assume the latter.
As I understand Rett it is a genetic mishap associated with a string of tragic associated symptoms some of which, like epileptic seizures, motor issues and maybe others, A2-73 have been shown to improve.
Although A2-73 will not edit and fix the underlying genetic issue, perhaps just some beneficial impact on associated issues may easily be enough to meaningfully improve the lives of these girls and secure A2-73 approval?
How long would we have to wait for AA not to happen in order to be sure?
Yep! Rather a few more pizzas, cokes and doughnuts.
That is how I think too. Many are concerned about the 'silence' on the PR front, but I'd like to think that Missling is being methodical working his plan in the patients and shareholders interest, not least his own, and 'without fear'.
It will be pr'ed in due course
The 11th CNS event has been confirmed on the Events section on Anavex.com
Indeed, what is there to worry about, the pps was over $6 just a short while ago and the sky is the limit, right?
Any thoughts on why we are down 5% today given we are now even closer to numerous catalysts?
Falconer, possibly or even likely all quite true. My point though is that a failure, or even seemingly a failure, in Rett would likely impact the stock price hard and for some time.
Two tracks here; the unmet medical needs which (hopefully) all here agree is the primary concern and Anavex as an investment with risks.
My point is that as an investor it might be prudent to take some measures to financially mitigate the risk of a Rett trial failure, rather than let any potential confirmation bias fool you into flatly ignoring the risk.
With the risk managed, one could potentially do even better if a later indication turns out positive.
This is not to be taken as investment advice and I will not be offering any potential solutions to mitigating the risk. There may be some options folks here who would venture a hint.
Actually, let me make a start.
While the short and imminent Rett trial may be the quickest and most cost effective way for Anavex to verify efficacy and potentially obtain early approval in an indication, it is also a risk! One that I think it is appropriate and ethical for Anavex to take, but also one that in IMO could be terminal or neat terminal for the company's future.
I choose at this stage to ignore any possibility that the trial will not start or complete.
Given that, as I see it, the challenge for investors is how to manage that risk.
If it goes well, then it will be a completely different ball game and thus in my view a waste of effort to dream up all sorts of other hypothetical scenarios.
I am being too simplistic here?
Just the job perhaps for yourself, OFP or others. And seriously, it would be good with a well researched objective review of potential issues.
PS! Could probably start from somewhere after the corner printshop debacle.
Well we are now down below $2, which I believe is the limit for NASDAQ listing.
What would that next news be, another reverse split or some solid private investment or a partnership/licensing deal?
But, you are right it can't get that much worse from here...
A lot of mice and rats have already benefited
Occasionally some useful facts too.
And while we wait for the next catalysts, especially trials start, yes the void is filled with sometimes wild conjecture, some rational predictions and deliberate sometimes false statements to the negative.
Hopefully most investors have a rational approach to interpreting it all and clear understanding and acceptance of the investment risks.
Is it conceivable that data from several studies AD, PD, DNA profiling etc. both pre-clinical and clinical all is part of a deep investigation including Ariana into just why so many tests come up with what seems to be ground breaking results?
One can imagine that extraordinary claims require extraordinary evidence and explanation to be more readily acceptable to the world.
Hence things are taking time having multiple independent investigations merge into a fuller understanding.
Indeed, would be nice if the elucidation they are working on in Lund could potentially satisfy those who have trouble with why A2-73 is not like other Sig-1 antagonists.