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A big IF
But if dual therapy patients have
Been switched to mono therapy
And there is an overall even or rising slope from that point for average of all patients than 12/12 should forever more be ANAVEX day!
Biostock: great post..thanks
Amateur..
I call on this Board and all shareholders and stakeholders:
Spread the WORD NOW..make the WORLD anticipate Dec 8th..
It's coming..
Please review MonoTherapy Graphs at 6 months..
They KNEW then that DualTherapy offered no benefit..
They also knew ..that MonoTherapy ..was the Cat's Meow! or as
we all call it now: Homeostasis!
You know everyone says don't get too excited..
you are making expectations too high..
GET EXCITED! Tell them based upon previously released Mono-Therapy Data
some Patients showed a reversal of symptoms and the company reports regression has been stopped in others..both facts..
the more people we have anticipating Anavex Data..the BETTER OFF WE ARE!
Do you think the Adaptive trial was Adapted to Mono-Therapy for anyone that wanted to switch? I think it was! Also at 6 months when the good Dr said ALL the DATA was converging, or there was no difference in either Dataset( I thought he was out there on that one) we could not understand that he meant that they had determined Dual Therapy was NOT ADDING to Mono Therapy Results. When they reported 6 Month results IMO many of the Dual Therapy Patients who had switched to Mono Therapy were providing 9 Month Data (or 3 Month for Mono for them) . This Data then confirmed the MONO THERAPY CHART..this might be WHY THEY PUT MONO THERAPY CHART IN PRESENTATION! this all conjecture on my part! but if I am right than with positive HAMD and lack of negative side effects and ease of dosing and not too expensive..than....
A2-73 is SOC!
That's it really isn't it? 6 months SOC? End of 2017? They are going to have ZERO problem filling Phase 3..and the MONO-THERAPY Line is going to JUMP out from Blind Placebo..And no wicked side effects from Donezipil/Aricept/Memntine..Just a bloody beautiful homerun..
Like all of us BBQ Longs thought all along when we saw that Mono-Therapy Graph..
And they have Biogen as a MS development partner..
I agree with Power Walker it doesn't make any sense that the MMSE is going to go up..UP after 3 months from 22 to 24 and then back down 6 points to 18..
The same CAUSAL AGENT that reversed a declining score is probably not going to turn around and be non-effective after 6 months.The Sigma 1 Ligand is not going to get tired..It is THE CHAPERONE!.
We are beginning to see what has been happening at Anavex and WHY the good Dr is NOT worried about funding. The Mono-Therapy HAM-D benefits continue, some patients are showing symptomatic reversal, others Regression Free Survival(If no one has used that phrase I officially Coin it!) what percentage ? Is it 100% on Mono Therapy? Ladies and Gentleman..
Go Look at those Mono Therapy Charts again..That MMSE Chart does not happen with Mild to Moderate patients 3 months into an AD Trial..
It DOES NOT HAPPEN..So we either have failed testing criteria, out and out fraud(Prana is doing quite well Thank You Dr. Mac!), or A2-73 is the new SOC..A 10-Billion Dollar a year Question..
The good Dr has already said he will need a BP to move this through..
I repeat the Sigma 1 Ligand, the CHAPERONE is NOT JUST IN THE CNS..
the CHAPERONE is in the HEART, the EYES..almost EVERY MAJOR ORGAN!
We do not have a TARGETED CNS SIGMA 1 LIGAND Drug, so it is not unreasonable to assume that A2-73 encourages Sigma 1 Ligand Action...everywhere! And that assumption would be shown to be true in HAM-D results..wouldn't you be happier too if every major organ in your body had cells dancing in....say it with me..our new favorite word:
HOMEOSTASIS!
One of my concerns regarding Anavex Now is just that, overwhelming the Company and instead of helping the Public, the effort delays the effeciency. the good Dr has said he will need BP to move forward with Alzheimers/Parkinsons..Even with the Short Cabal..I look forward to Dec 8,10 and 12..What a year 2017 is shaping up to be..
Xena
Please explain what this post references for Anavex in layman' terms.
that is a great point powerwalker..
it was originally designed as a 26 week study..
now they may have part(20) of the SAME Patient Population Group being their own Baseline! After 6 months on Dual Therapy, after 6 months on Mono..
THere were 20 Patients on Dual Therapy after 6 months..and then..include the mono therapy patients from the first 6 months..
here are 27 Patients on A2-73 after 52 weeks. Maybe....
some Dual Therapy Patients dropped..and had to wait until after 6 months had passed to begin Mono Therapy.
The Good..I look at this as a statement of "Progression Free Survival".
Not saying it's a cure, but Patients are living their lives without signs of continuing deterioration.."Stopped" is a word used the PR.
don't understand statement, "a few points better" on what scale? MMSE or ADCS-ADL.
A few points on ADCS-ADL at 9 monthe is something like this..
The no treatment Line at 9 months is down a little less than a point a mo from 70 to 62, Donezipil helps a little so from 70 to 65,..so Mono therapy with A2-73 would be a few points better to 70 to 68..pure guesswork..
Personally that would be insanely successful at 9 months in mild to moderate care..
but what if they meant a few points in MMSE! at 6 months dual therapy went from 21.5 to 18 so another 6 months would take us to say 15.6?
A few points better here would put Mono-Therapy at 18.5 after 1 year from a start of 22..
So listen- that is not bad or unreasonable until you look at the Monothrerapy Line from MMSE at 6 Months! at 3 Months the MonoTherapy Line gose UP ! UP! Nothing ever goes UP in Alzheimers.. We dismassed it because the Short and DIstort told us to..because the company said it saw no difference in dual therapy.but converging success(get it now?).
IF MMSE at Monotherapy goes UP after 3 months from 22 to 24 on MMSE..After one year is it reasonable to think that those numbers are going to go to 18.5? No and Hell No..Now that WE KNOW MonoTherapy is the bomb, the UPTICK from 3 Months to 6 Months in MMSE was NOT A GLITCH but Action Jackson..yessir..Pharmacokinetic glorious Action.
So after reaching 6 months to 24 let's say we maintained my new favorite word.. HOMEOSTASIS..
Honestly ..don't you think that means "Progression Free Survival"
What PERCENTAGE of Patients experienced PFS? Could it be 100%?
I hypothesize the MMSE for 7 mono therapy Patients stayed the same from 6 months to one year..BUT if the other patients did go to MonoTherapy as Powerwalker suggests after 6 months..than would not have their MMSE scores have gone UP after 6 months?....I think the good Dr.'s of Anavex are being modest.I am excited to see the Dec 8th data
so ..a non affiliated Alzheimer Dr. tells you he's never seen anything like it..and you wonder why the price is only at $3.5?
Because..a lot of people do not want a treatment for ALzheimers..especially not from Anavex with it;s 5 employees...just a tad of resentment..just a tad..
can't blame them..look how much $$$$$$ they have wasted..
and teh TIME!!!!!!!!!!!!!!!'
and the LIVES!!!!!!!!!!!!!!!!
you can understand their bitterness and envy and greed..
Where is our pride?
I promise you this..this is not the only shoe to drop..
2 weeks until Dec 8..
Biogen? MJFF? Rest Syndrome? HAM-D trial?
Non-Opioid Phase 1 Safety Trial?
It's going to get loud with all those shoes dropping..
i have got to be close to 15..
if you want to feel better about being long in an endeavor where
99 % of everyone else has lost trillions..
well..look at AERI..look at that chart..because that is our chart for next year..and then some..
30 Day tax loss sellers have a tough tough tough decison..where is this stock gonna be Jan 1?
The Shorts are not playing with their own money IMO.
They are playing with BP money, meant to delay, delay delay Anavex at all costs..BP has probably dumped a Billion into "hedge funds" as working capital to delay Anavex As Long As Possible..
ALSO, don't forget ..shorts do not believe the 6 month data, were able to thwart a Biogen Rally AND based upon PAST Alzheimer Studies have
NOTHING to FEAR from 9 and 12 month results..
Time is their sickening friend..
The question YOU have to ask yourself..is..
are they right?
Go look at the Mono Therapy Line from the 6 month Data release..
and you have your answer..it's my new favorite word..
Homeostasis
i think so to power..
but ..i am not that worried either way..
obviously Mono-Therapy and 6 month data is what is relative..
and oh my is it..relative..
Just the FACTS , nothing but the FACTS!
hmm..Homeostasis..my new favorite word!
well, do you think this is bigger than Biogen Announcement?
5 million shares sold short..say we get at least double the short..
Dec 8 is only 2 weeks away..only 2 wweks..Thanksgiving, Hanukkah and Christmas Presents for one and all!
Hi Ziggy,
I just ordered some Muscarinic Vapor..I will keep you updated..how that goes with Vicks Daytime cough..haha..just kidding..kinda.
Great point Ziggy, Nice Timing by the good Dr.
I really did try telling everyone..that the non-dual announcement was
an incredible positive..
Happy Thanksgiving!
mjw
well we didn't even get to open market before we stARTED talking price?
We by nature are a short term beast. Next meal, next glass of water, how long do I have, what time is it?
step back,,step back..
think of all the trillions in failures for Alzheimers Treatments..
the pain the fails the death the sadness..
step back..
this is a momentus day..not because the stock is going to $900 plus..
but because Anavex..the little company that could..HAS..
it is a moment in time, to appreciate, to savor, to taste, to celebrate..
buy more stock if you are able, trade if you dare(i just have such a hard time stomaching the risk of missing THE move)..
But for goodness sakes you are one of the few people out of BILLIONS that are here..that get it..Enjoy it..
Anavex is a speculative BioPharm..quit asking WHY..and enjoy the..
THEY DID IT!
Thanks Amateur..
I do wonder though ..because if the Mono data is that strong..
It would be hard to tell patients "No"..
it is going to be a fun day and i know the stock is going to trade up and down and up and down and everyone will get caught up in the price of the stock again..including me...but really..can we just take one moment, before the market opens to say Thank You..to the patients, the docs, the nurses ..not just for Anavex but for every CNS disease that is trying to be delayed, cured, treated..My father died of Alzheimers, and was an MD ..and I remember the effing day..when they took his practice away.and the confusion in his very soul...
I am so happy right now for the families and their loved ones..
no needles, no vomiting..just homeostasis..just being able to say I love You while we are runnning out the clock..
Could we all just take a moment of Grace..
in about an hour, it's going to get a little crazy..
Thankful to be off "suspension" wonder how long I can make that last? HAHA
Amateur..So do you think this is PharmacokinetiK confirmation?
BAM! No mention of Dual Therapy or MonoTherapy..I think the good Dr let any and all go MonoTherapy..
The good Dr has said for quite some time that he is not worried about Phase 3 funding for Alzheimres Parkinsons or Rett Syndrome..so why should we?
Any Investment in Anavex is going to be met with an incredible return..
I am going with the good Dr...and not worrying about funding either..
Safety is a homerun, Tolerability is a homerun. Efficacy is Homerun..
SOme Institutional Holders are about to add on to their positions methinks..
Like I tried telling everyone..the good Dr by saying there was no additional benefit with Dual Therapy..was doing his best to let you know.
We have the drug..
Amateur..
Do you think everyone went Mono-Therapy? Since an open Trial the Dr.'s would have had some mono therapy patients data from one year when 6 months was complete..my point is we only saw 6 month Mono-Therapy Data..but Anavex had 1 year Mono data on some patients..do you think all Mono Therapy was so strong, that they allowed any and all to convert?
Because if that is the case, the 9 and 12 month data could be..how do you say..convincing?
Mono Therapy is thus born. The computer Models couldn't know just how grand A2-73 was by itself..and we have A3-71 in the pipeline..oh my
again, we can not have DOSE OPTIMIZATION until we know what DOSE OPTIMIZATION is..I do however believe that we have the Maximum Dose which is well tolerated, They are two different statements..
Could this be a dual therapy agent?
VtVt ?
Remember power walker the short Cabal trashed this data as insignificant, meaningless, too few patients and then they unleashed computer short sell helll..
The good Dr has tried to encode a precursor for us by dismissing dual therapy..
he can't say anything else..
This is an oral presentation. Probably with accompanying poster..
Went to CTAD found oral presentation not poster(s) on10th.
Saw something about Dec8 availability of data..
Can that be confirmed?
thanks cbd..
i had to recheck that mono therapy data and
when I did ..BAM...... MMSE line going UP at 6 months..And that is an average of 7? since 24 is low end of normal.
Are you kidding me?
the good Dr could not have given us better news than dual therapy was a bust..
COULD NOT HAVE GIVEN US BETTER NEWS!
C
I thought everyone had committed to memory the unbelievable results of the Mono Therapy group?
If any of you have not , I strongly urge you to go review this data!
At 6 months his group was separated in at least 2 charts for Adcs and MMSE ..
The assumption I make is simple logic;
IF we are moving forward than we must have a positive result!
Good logic?
IF dual therapy has been ruled out as having better effect(fact by good Dr statement) Fact
THAN the good effect we must be talking about is the result of MoNo-Therapy whose EFFeCTS were separately displayed in 6 month poster.
The market doesn't realize what I just said,, it's time to accumulate,
You are all welcome!
So than if everything in my post is factual that would mean this post is
Well,, misguided?
MMSE on 7 patients of mono-therapy from 6 month chart :
Start 22 end almost 25.. 24 is a low normal score for MMSE. Facts
ADCS-ADL 6 Month poster :
Start 70. End 70 Fact.
Some higher some lower as these are averages : fact
These were my main points Xena
Which of these are not factual?
What I am pointing out is that many of
Us saw the monotherapy data as the results for which we had hoped for..
Go back and look at the MMSE score going UP! 24 the score same as healthy score! The good Dr in his own way has told us that the positives of Monotherapy have continued.
It is only 7 patients but we know that the average, average of all monotherapy patients was no deterioration at 6 months! So some must have done a little better ! That is unbelievable at 6 months of mild to moderate Alzheimers..
We have the drug!
Prepare the drums..
We are going to launch a Humanitarian Apoeal to President Trump and FDA..
Not to overwhelm Anavex but to petitition our leaders to help them!
With positive ham-d results already announced and the announcement of mono therapy success should be confirmed dec 8-10 with data at CTAD
Frill you have had some exceptional insights and your questions have led me to yet another presumptive conclusion. Since the good Dr has revealed to us that the combination therapy (20 of 27 cohort) has shown no differential or increase in benefit to mono therapy and we know that mono therapy has been great enough on 7 people to validate a Phase 3 trial which will cost tens of millions dollars..
Than my friends is it not a reasonable assumption that the 9 and 12 month results for that cohort of mono therapy must demonstrate as good as or better than current SOC?
And with minimal negative side effects and positive HAM-D
At 6 months
The number is down to 27 participants.. if more "n" drop out they will share "why" just like they did with 5 who dropped out..
Remember. This is not a blinded study..they have immediate access to all data except maybe pharnacokinetic..many patients are close to two years..
I again repeat. The company have three other promising drugs, they would not destroy lol credibility for A2-73.. if the data were less than exciting they would just move on..
Not hold oral presentation at CTAD..
They have TOLD US the mono therapy
Data is the deal..( No dual benefit).
Honestly. It is simple logic.
Accumulate
Thank you dRx ..that is correct..
You can't get return without risk.
It's like Groundhog Day all over again, no one ain't seen nothin! What short Cabal?
Jimmy
This Co and the opportunity will go from " fears of dilution, lack of efficacy, mismanagement, too many directions, too many drugs in pipeline, not communicative enough, too slow to sell out to a bigger company, yada, yada, yada,,,
To
It's too expensive to buy now..
What a riot
Could this be a conjunctive therapy with A2-73?
http://medicalxpress.com/news/2016-11-antibiotic-cell-brain-areas-alzheimer.html
From Limited research, Injection/or IV..no oral avail.
MD would have to go through risks/rewards. Side Effects appear
negative and diverse. Also, I would assume: risks of loss of effectiveness as Anti-Biotic if over used.
Is in Generic Form..so appears relatively inexpensive..assume that means has proven relatively safe..
"Ceftriaxone seems to increase excitatory amino acid transporter-2 pump expression and activity in the central nervous system, so has a potential to reduce glutamatergic toxicity.[3"
Point to posting this story, is so many of these maladies are pointing towards an epidemic of diabetes. The inflammatory cells may be a wave reflex to agitations due to lack of insulin to calm the systems.
Homeostasis is a great goal, but my guess is without proper Diabetic care, it continues to attack everytime your body processes food, or stressful events.
I would think teaming up A2-73 with a Diabetes Treatment should be a serious consideration..
Announcing Victory through Failure.
I have requested other posters fully extrapolate the implications of
Mono-Therapy vs. Dual.
1. IMO: Our Trial will now be using Donezipil Patients as Placebo Group..No dual Therapy Group..
a. we currently beat Aricept if only by lack of negative Gastrointestinal reactions to A2-73 vs Donexipil(Aricept) and side Benefits related to HAM-D test- vs Anxiety, Insomnia et al...
2. Using Donezipil as baseline allows A2-73 to REALLY give Patients a CHOICE..and as a stand alone would become very successful just from those who do not wish to experience Side Effects of Donezipil.
3. LOGIC, since we know there is evidenced Efficacy in Phase 2a over and above Aricept by itself, and since we now know, that there appears to be no benefit to Dual Therapy, the very simple conclusion is ..
MonoTherapy of A2-73 in multiple Alzheimer's tests shows greater efficacy than Aricept/Donexipil. Good enough to command Ariana, Cogstate and Neuronetrix, MJFF, Rett Syndrom Assoc., and yes, Biogen, to continue to want to partner with Anavex.
I still do not believe the market has taken into account the full positives fo the good Dr's negative commentary..
Side Note: Why would stopping PAIN without using destructive Opioids increase the value of Anavex? Non-Opioid Pain relief is such a small market anyway..What 5-10 Billion a year? could use to help Heroin Addicts..really Anavex should just sell off this drug for $2 to avoid losing any more market value..You gotta love this stock..Accumulate!
Anavex hires Ariana, next Interview:
No Benefits to Dual Therapy! Logically you would think this a negative!
When we put them together we receive no greater benefit..
NO GREATER BENEFIT over ????????? the drugs used separately?
NO GREATER BENEFIT over..say it with me each drug as Mono-Therapy!
That makes sense...
Since we KNOW that our A2-73 has shown Efficacy so far with Dual Therapy, and that efficacy, not including HAM-D Positives, appears to at least equal Donezipil mono therapy, than is the good Dr. trying to
cough out that A2-73 in Mono Therapy is BETTER than Dual Therapy and MonoTherapy with Donexpipil?
The good Dr can not say ..Mono Therapy with A2-73 is better than Dual Therapy, or better than DZP. Because A2-73 Phase 2a is about SAFETY and A2-73 showing Efficacy, not measuring it.
So the good Dr could not say, we appear to have the new SOC, and it appears to work better without DZP, but really,
Is that NOT what the good Dr. JUST DID?
Ariana is going to help us clarify what we have and what we don't. We don't have a drug that plays better with Donezipil Type Drugs(Memantine, etc..).
What we have is a drug that plays really well with the Sigma 1 Ligand, a Homeostasis Chaperone located in EVERY MAJOR ORGAN throughout the body..
Heart, Mind, Eyes, Diabetes, CNS, Depression, etc..
Ladies and gentleman..Biogen is one lucky Company..
It will not take Biogen long to figure this out..
Not long at all..
The good Dr. in the interview said something along the lines,
"There does not seem to be ANY BENEFIT to DUAL THERAPY".."Taken independently of any current therapy"
here is the logic that needs to be followed (IMO) regarding this statement: Right before the good Dr says no difference in benefit between dual/mono he states the compound has shown the ability to repair cell balance, cognitive function, better cell functionality of body" "whats bad for heart is also bad for the brain"
And the OPPOSITE is probably true for A2-73! What is GOOD for the Brain is Good for the HEART!
Back to Logic
A: We KNOW that there is Benefit to OUR Treatment: So OBVIOUSLY, the good Dr is NOT saying there is no benefit, just that there is no additional benefit to adding Donezipil or any other current SOC.(all use same modality)
B: Since we KNOW A, than the good Dr.'s Statement LOGICALLY means that
the Benefits derived in MONOTHERAPY are NOT ENHANCED by DUAL THERAPY!
So we may logically assume as of this statement:
Anavex studies will be moving forward as primarily MonoTherapy!
and that the Benefits observed are same as MONO THERAPY!
I think it's GREAT NEWS..Save big $$ for Governments AND
lose the side effects of DZP..NICE!
It would be nice if George or Dado would comment here regarding Monotherapy benefits..My guess is that there are some negatives..but what are the LONG TERM positives? The Market is not recognizing the LONG TERM POSITIVES! We will REPLACE DZP altogether!