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Great analogy!
Increased cash position and funding trials.
From 10-Q:
It means that I am staying long and strong
I am paraphrasing from memory, but Missling was at pains to point this out in the Investor presentation last week.
It is the first time I have heard him being really clear that all 28 remaining patients stabilised, which is better than SOC, while the super group improved from baseline.
He went on to say that they are now characterising those super responders, such that this knowledge is used for the P2/3 design for optimal outcome.
I can't even find any info on the Anavex website that the annual report is due Monday?
It makes sense to me that the pursuit of the combo patent must have utility coinciding with some dosing optimisation of the two compounds reflected in efficacy.
Time and PR well tell - exciting!
I would think it likely that Anavex will apply for a new method of use patent for Anavex 2-73 once conclusive data for Alzheimer's is established. As someone else said, Anavex has a US granted patent for the same molecule in cancer indications.
Agree, you've got to assume that Missling & co. have solid reasons for confidence that the Rett trial WILL meet it's end points. It is a bold move and not all great news were the trial to fail.
As I recall Missling has said, possibly in an interview, that A2-73 has already been manufactured for the upcoming P2/3 Alzheimer's trial. Probably also enough ready for Rett's and maybe more.
Did your authority also explain the statistical method that should have been used and would show that stabilisation is a false conclusion?
yeah, the board is full of extrapolations and interpretations while we all fill the gaps between data releases
Indeed. We don't have access to individual responses nor can we infer them from the data available. We have the boot strapped method of comparing to SOC.
Based on the totality of data available I continue to be long, until perhaps it turns out to be a bad idea - only time will tell.
The slide I am referring to is 29 as pictured in my post with the slide no. printed on the bottom of it.
This in reference to Falconer's efforts to represent how the error bars might have looked were there non-responders in the n=25 group. I am pointing out that Anavex provided a way of comparing the A2-73 results to SOC.
I am long because the P2 results warrants a P3 study, the outcome of which non of us can be sure of in advance. Based on the available statistical data it seems a sound position, at least to me.
PS! Notice the P values!
This is where the adaptive trial design approach that Anavex have taken is the smarter way to go.
The A2-73 P2/3 trial when it comes along with a partnership will change all that - patience is a virtue.
Not difficult to be almost always right about Alzheimer's drugs - they fail 99% of the time!
I'll second that too!!
I'd second that!
Watching Dawn of the Planet of the Apes on TV just now. Some parallels with Anavex; the film that starts with the ALZ-113 virus being used on apes in the lab and then on the scientist's farther with Alzheimer's. Guess what, the farther starts playing the piano again!
The answers is NO!
Now we have to see if the P2/3 trial with up to 300 patients, optimised by the leanings from the Adaptive P2a trial and extensions, will confirm and even exceed the current published data.
The longer we wait the sooner we will all get rich and Alzheimer's free.
Just FYI:
Outstanding Shares
A Class Other
Current 39 611 000
Volume Average 3-M daily
in No of shares 1 383 546
in USD 5 727 880.00
in % of Market Cap 3.49%
Shareholders (Top 5)
Holder Name, Position, % OS
Athanasios Skarpelos 1 306 458 3.66%
The Vanguard Group, Inc, 1 199 161 3.36%
BlackRock Fund Advisors 1 170 599 3.28%
Christopher U, Missling 1 003 250 2.81%
Northern Trust Investments, Inc, 361 088 1.01%
Source: FactSet
Xena,
Good find, which I have no professional qualifications to judge. However, from what I have heard and read, it sounds like a very sober and real reflection of Alz treatment.
To me this means that Anavex should have no issue recruiting participants for P2/3, including those who have never taken or abandoned available SOC as controls. The control/placebo arm could be short in duration before switching the patients to A2-73.
The A2-73 phase 2 lack of placebo control discussion is frankly getting tiresome. Rather pointless especially given that phase 2/3 will be placebo controlled as it should.
looking forward to 2017 and the announcement of P2/3 Alz trial and the start of p2 in other indications.
Good luck to the patients, their families and all Anavex Longs.
Excellent work tracing the patent history.
So we have a patent granted on 2-73 good till 2035!
Given this
According to Google Patents: http://www.google.com/patents/US9180106 the patent was granted. The priority date is Feb 26, 2009, so that would be the date from which protection starts and last for 20 years I believe.
Biogen CEO Update PR.
"Our near-term priorities are clear," Mr. Vounatsos said in a prepared statement, adding that the company intends to "reinvigorate our pipeline in the areas of neurology and neuro-repair" and advance an experimental treatment for Alzheimer's disease, among other initiatives.
One wonders what this "neuro-repair" statement may relate to...
We will not know the subject and content of a patent application until 18 months from first filing (priority date), when applications generally are published by the USPTO.
MacFarlane and Cauldfield seem very sure to run the P2/3 Alzheimer trial. I can only think that Australia is funding the trial and that this is the partnership for Alzheimer's that Missling has been referring to all along.
Rett's and PD can be managed and funded by Anavex probably with some grants. Guessing the magic $8M is from as yet unannounced grants. With A2-73 hitting the market via Rett's in 2017/18, all this if true could mean no dilution - ever!
Or am I miss interpreting?
Slide 21 "PART B is 52 week orally daily dosing regimen of between 10mg and 50mg without any dose optimization"
It really is time for Anavex to overhaul their website. E.g. this statement is in the About section:
"A highly encouraging synergistic effect has also been observed between ANAVEX 2-73 and donepezil (Aricept®). The combined therapeutics, referred to as “ANAVEX™ PLUS,” produced up to 80% greater reversal of memory loss in Alzheimer’s disease models versus when the drugs were used individually."
Either the models were wrong or most of us are misinterpreting the real-life results.
Yes that would me take on it too. That being the case as you say, even more convincing.
Data is for ALL patients and as such clearly better than SOC. Keeps us in suspense on just how good sub group results are.
At 31 weeks the difference between mono and A273+D was not stat sig. Missling may well have had indication that mono potentially gives better results beyond 31 weeks, but any such info is not public - yet!
Saturday we should know more.
Missling had to state it with the sentiment that there is no significant difference between "co-medication" and 2-73 as per publicly released data thus far. 41 week and beyond might say something different, but if so will not be public knowledge until 10th Dec.
StarMine is not designed to assess biotech stock.