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Our army gets slaughtered on pork hill every single time regardless of transparency. We need Anavex Public Access push! We need our patients to start demanding the drug now.
Put the heat on getting this drug out there to start helping people.
Company can't be a part of that .. yet..
But we can, and I am!
Anavexnow!
Someone asked to explain away frustration at apparent lack of communication between Co. and Investors.
Simply, the Co. is at War with nefarious combatants(short Cabal) who stop at nothing to delay and destroy our progress.
The less information they have the better off we all are...
Positive investors suffer, but who would have imagined the alignement of wickedness against treating: Alzheimers, Parkinsons, MS, Autism, Epileplsy, Insomnia..Who would have dreamed our world had become so evil, that wealthy succesful people would try and destroy progress against these Hu Maladies for a buck?
It's OK that the good Dr is playing close to his vest, and yes even things that perhaps he could have done better and yes even no press confrerences..
becasue bad people are just that ..they are just bad. Once you have sold your soul and eternal darkness awaits..what is going to stop you from doing bad things? the lack of ability ..don't feed these monsters..
read teh Tea Leaves you are given..He said no more cash needed?
How is that possible? Grants? In Licensing are the only ways..
Success? Caulfield and Rett Syndrome say YEA!
FDA has voted Yea! Multiple times.
we are not a one trick pony iwtha 99% fail rate anymore.
Feel Good..Accumlate..Our team has accomplished much with little and pissed off the entire BP world..what more do you really want?
caulfield Annual report Page 28..
Alzheimer’s drug trial success
Early research results of Anavex 2-73, a drug which aims
to address the symptoms of dementia, are positive.
Trials at Caulfield Hospital are using Anavex, which, unlike
current medications, is the only drug designed to both relieve
symptoms and slow the disease’s progression.
The first phase of the trial began in December 2014 and the
next steps will involve further research with a larger group of
participants in 2017.
Rett Syndrome Assoc. ..it was update on SCOUT PROGRAM for Rett Syndrome and how the Assoc.had impacted succesfully research on Rett Syndrome.
the part moving to human trials was posted on iHUB..but my time looking for is over..
I understand. If I have time..
today we focus on three points of information that are in the Public Domain but not really Publicly known:
!. Dec 10th Anavex will present 9 month and 1 year final Phase 2a Data(except for PART B 2 Year Extension) They may have some PART B Extension longitudinal general/ specific Health Data regarding overall Group or MonoTherapy but that is conjecture on my part. Cogstate AND Neuronetrix are a part of Anavex Presentation Group.
2. Caulfield Hospital has quietly reported that in 2017 Phase 3 will begin for Alzheimers with Anavex.
3. Rett Syndrome has confimred Phase 3 in Rett Syndrome in 2017 as well.
I believe the market has priced around 10% of this data into PPS.
Many people probably trying to figure out tax loss and buy back closer to Dec 10..
But I would caution you..Anavex is on fire right now..Biogen, MJFF, New IND...
Caulfield has given us a pretty good idea of Preliminary on A2-73..
The Data is good enough for Phase 3!
I don't how you say Seller Beware in Latin..
truth foo bar!
wde have independent confirmation for two Phase 3 Trials for Anavex A2-73
in 2017. Rett Syndrome Assoc and Caulfiend Hospital.
Guess Dec 10th for CTAD 52 Week Results for Alzheimers must be half way decent hunh?
When you are a soldier dug in to the trenches on the front lines and the bombs are going off in front of you and behind you, how do you know you are winning?
Well in our case, you need look no further than Biogen, or the two (three Really) human trial for Alzheimers and Rett Syndrome for both, which we now have third party confirmation. We should soon hear about a third Parkinsons(MJFF Finished so far very Positive Animal Study) and maybe a fourth(Autism? Depression/Anxiety?Insomnia? Epilepsy?).
I do not understand the frustration at our management when battling a Disease with minimal capital invested, that has destroyed TRILLIONS in MAJOR BP Research? Who do you think we are? We are soldiers in the trenches, we need to keep our heads down and obey orders!
Our General the good Dr. has delivered on almost EVERY SINGLE FRONT!
It's WAR..BP does not want AVXL to succeed, it's embarrassing and destructive to their bottom line..Believe Me, the Army we fight is well funded.
Dig in, remember we got a defector in Biogen, we have three Hu Phase 3 Trials coming- 2 in Annual Multi-Billion Markets- we still have Hu Safety ofr A3-71( I think waiting for A2-73 to find Distribution), and the PAin & Cancer Meds.
Your frustration should find reason is all I'm saying. There is a reason Trillion of Dollars have failed..Alzheimers is a tough nut to crack. Let me play you a song on y piano or paint you a beautiful picture to prove it.
Frrol
Honestly I think your frustration is misplaced. And I say that feeling the same way! Our total number is only 27 with 7 of those monotherapy. This leaves only 20 as regular DZP and A2-73.. ( all of whom asked for 2 year extensions!). My point is when you pool together numbers from 20, I would think that there are at least 25% of patients that you have minimal effect if any.. this patient pool of 5 then leaves 15.. if you take those 15 my guess is the numbers are steady or up (SOC!) but when you add in those 5 it's doesn't appear effective..
Also I think the numbers for AdCS-adl were not right at beginning( too high) because caregivers may have been overly positive trying to get patients into study..
Anyway,, on multiple statements Anavex says they see overall effect! Believe them, I do.
Caulfield Hospital has announced Phase 3 in. 2017. Get excited.
It is good they brought Ariana in, and I think they brought in Biogen for MS and Mjff for Parkinson's..
everyone quit judging a fledgling biotech treading where Trillions of Research Dollars has found a grave, instead celebrate the lack of bagpipes being and shovels being shared..
Leo,
Parkinson's is validated in computer and mouse models for A2-73 and in HU safety.
Rett Syndrome the same.
We are tied in with 2 organizationnnbgqgf
Since we have Safety I believe we can set up P2/3 now for both indications.
The overall health indicators must be substantial not just for this population but for patients in general, Insomnia, depression.,-- since these are sometimes behavioral rather than chemical - the bar for cross prescribing these issues for a non Narxotic non addictive drug should be pretty low.
First of all A2-73 is in Human Trials for
Alzheimer's not Parkinson's . Second A placebo effect is going to be different for different populations regardless of the disease, hence why you have different placebo groups for the same disease.
However, after a certain number of studies The Placebo Effect becomes predictable for many diseases based on N= 100,000 plus placebo patients..
Since all people are taking same drug with same disease the Placebo EFFECT becomes PREDICTABLE.
I have gone over this so many times. The Placebo Effect for Alzheimers is GONE before 12 Weeks! Does not exist. After 6 months it is plain cruelty to keep patients on a Placebo when it comes to AD. Since we have so many failed Placebo AD patients already , honestly it's ridiculous to have any Placebo group unless you are blinding caregivers so they don't cheat, the patients could not cheat if they wanted to.. and believe me that wish they were able to cheat..
Anavexnow!
Yes Leo
Mono therapy had a separate line out for MMsE
That finished at 24 a normal brain score after more than
6 months.
blu_1 you are both right and possibly both wrong..
I am convinced blu that you are correct as far as DZP is concerned, in that ONCE a patient has been previously treated & current with DZP, there is competition and limited success. DZP is only a delay, not a solution. BUT a great post by another, pointed out that Computer Models showed both Drugs when starting treatment at the same time showed tremendous synergy. It may well be that both drugs have to start at same time. My guess is that will be a Strata in new {hase 3 Trial Design.
There are plenty of patients that hate DZP due to side effects, so finding Enrollees who STOP taking DZP probably not that difficult. My guess is as we have an adaptive study, that SOME CURRENT Phase 2a PART B Extension Patients may be allowed to go to Mono-Therapy with A2-73.
That is a risk for them, but, if those patients were to respond like the Monotherapy patients at 6 months, that decsion could have IMMEDIATE and FAR REACHING IMPLICATIONS.
BUT you are right regarding the Mono-Therapy Group doing so well(almost 25% of N = 27 group holding MMSE Score of Healthy Brain! 24 after 6 months! UNBELIEVABLE!
The ONLY DRUG EVER TO BE SUCCESSFUL!
As far as MTD of entire patient group, i can not remember the good Dr saying this, but that I do somewhat recall being disappointed to find that for the 6 months this was not the case..
So IF Zena did hear the good Dr say that Patients have been upped to MTD, that is about all we can expect.
Having 25% of patients on MonoTherapy was a stroke of genius.
Can not wait to see what PK with MTD and Ariana have in store for Phase 3!
I see at least 4 Strata and this does not include the 3 defined Variable forms of Alzheimers. SO conceivably you could have all 4 Strata within all 3 Lines of Alzheimers..Maybe..
1. A2-73 Monotherapy
2. Begin A2-73 and DZP at same time(group not experienced to either
3. begin A2-73 with current DZP treatment continued
4. Begin A2-73 with concurrent ENDING of DZP
Where many people get confused is when they think dementia is a disease in and of itself. In fact, dementia is the result of a disease, brain disorder, or injury. It is not a disease, but a range of symptoms that tell us a disease or condition is causing physical changes in the brain.
There are several types of dementia, caused by different underlying conditions. The most well known types of dementia include Alzheimer’s dementia (AD), Parkinson’s disease dementia, and Lewy Body dementia. But there are also types of dementia caused by vascular disease (such as strokes) and Frontotemporal dementia, which is caused by the breakdown of nerve cells in particular regions of the brain..
courtesy of Get Healthy Stay Helathy
jon
hope you read Caufield Report..the Goods are just that..
great find neiu!
Our cake(Alzheimers) and eat it too(Parkinsons, MultipleSclerosis, Autism, Depression/Anxiet,Insomnia,Rett Syndrome, Epilepsy,Pain Relief, Cancer)!
Dado,.. Great insight and Thank You.
One year into an Alzheimer study normally you join the other
99% of failed trials. Really 100% fail rate. Aricept is still just a delay..
We could be the first drug ever to show reversal!
Less than 2 months away. Possible success agaimst
Parkinson's and Biogen(Multiple Sclerosis) give us much more than just a fallback
It's more like a can't lose..
If you are a speculator..
large short, unbelievable upside, more than one trick pony
Enough cash...and a major announcement(s) soon.
Sounds like a great time to speculate..
Anavexnow!
anavex can't release news about A2-73..on Alzheimers..
they certainly may update a pHase 2/3 for Parkinsons..
Oh My..
Dec 10th..It is an ORAL PRESENTATION with Cogstate and Neuronetrix..Sweet..
about 2 weeks ago Anavex traded over 25 Million shares,
As high as $4.5 if I recall correctly.
the Shorts collaberated..teh Momentum Shorters stepped in and
Motley and the other usual suspects attacked..DILUTION they cried..
and the Fools sold..so now..No Dilution? What happened Batman?
Who really traded 25 Million Shares two weeks ago with Biogen Announcement?
Shorts are feeling a little tight right now..I Guarantee it. well you know..
guarantee agasint this short cabal is tough..but hey! Dec 10 ain't that far away baby..
You got lucky to get a second bit. The short Cabal opened the door for you.
it's ok..it happens. good for you for taking advantage.
you got to enter the door with so much more positive info..so much less risk and even more upside. Brilliant for you!
the stock traded in oned day 25 Million shares with Biogen Announcement..
How many of thsse shares are still short?
We are going through 5...in short order..
Shorts on the run! Shorts on the Run!
Well the good Dr. Stood Up and said
52 Weeks and more!
52 Weeks and more!
Ariana and Biogen are on Board
and the Shorts are on teh Run!
How many millions of shares
that they don't own, have they sold?
oh my
The Shorts on the Run..
Ariana may have already worked it's magic?
Man that was fast! One day Ariana hired and one month later
we get the goods at Major Sci Conference.
Anyone else a little excited?
Shorts on the run! Shorts on the Run!
and when the Biogen Cam into play..
They put the Shorts on the Run!
25 Million shares oh Hey..
Shorts on the run!
everybody raise their hands that think Biogen SAW these numbers before they
inked Material Supply Agreement?
So what type of numbers do we need to prove efficacy? to be successful?
honestly..we already have it!
we have already shown SOC Efficacy..
but hey..all of you doubters..let's say you want a stable ADCS-ADl for 9 months and a year..
So in my humble Opinion..
Our original ADCS - ADL numbers were skewed high(patients wanted to get in to trial) so I like the number for ADCS-ADL that was used in first Poster:
64 as base.(AFTER on and off 5 wweks)...
with 64 as base..in 12 months a non treated population would expect to see
a score of 52-56 pts..That's it ..that is where are number need to beat to show efficacy..
There is a reason Patients begged to stay on A2-73 and are still taking it well after the original 6 month design..Their scores are above 55..
and my personal guess is the monotherapy line..well..
mmse of 24(normal score) is perhaps still right there..
in which case..Katy..is that a Bar in your hand..could you please
place it across this door?
the downside at this price is ZERO, with Biogen in the bag, MJFF, and positives from both A3-71 and Non-Opioid Pain Relief Candidate.
Not to mention Insomnia!
So ZERO long term risk..what's the upside of dealing with a Biogen or a Phase2/3 for Alzheimers that is designed for success?
We got to start at Biogen's 29 Billion dollar run up..
$29 Billion takes us to over $700 a share in price..
$4 to $700? with limited downside..
in less than two months..hahaha..that is about
50,000 times better than any odds at Vegas..
Roll the Bones Baby..
great post frrol,
simple, to the point.
later i will take some time to put up possible expectations for ADCS-ADL..
Placebo Group and all..
actually we have number 2 as well!
because of the length of time and the number of unsuccesful Alzheimer Trials, a tremendous Database exists for Placebo Groupings for Alzheimer's studies. Any data you want from probably hundreds of AD studies with tens of thousands of Placebo recipients.
You don't have to be a Rocket Scientist to figure out the data..
it is consistant to the placebo group.
Axovant and Biogen updates Fri of CTAD
Anavex 38 and 52 wk updates Cogsate and neuronetrix inthe house
P1-33 interesting; metamory data
Avanir
Alzheon
P3-31 Meteic Data
Quick glance
Look for Biogen and Axovant to be freeted with suspicion.
Anavex is no longer a one IND pony
We shall see
Biogen!
Michael J Fox Foundation!
Rhett Syndrome!
One Year data set I. Dec .
New Data capture firm to evaluate quickest run through
Phase 2/3 for. Alzheimer's, MS, Parkinson's..
Saftety profile off the charts
Preliminary dataset for Depression/Anxiety/
Preliminary Datset for Phase 2/3 Insomnia
New IND not even aware of
In 3 Years?
The good Dr can not control the brutality of short & distort,
Longs selling momentum tops to trade new buyers,
BP encouraging newsletters to keep development poorly capilayized
By keeping cost of capital high with half truths!
What you want fro the good Dr is exactly what you don't want from the foo
Good Dr. We just need him to keep building the puzzle
Until it looks like the picture on the box.
So.. we don't get what we want when we want it
Instead it's one or two months later with a more data
At a major sci conf with cogstate and neuronetrix
And we are waiting for mjff? And Biogen?
And new ind and phase 2/3 for ad and you call the good dr a con man?
I'm sorry but jyour post makes no sense.
Anavex is not I. A rush! Anavex has theee compounds
Which are proving to be. .. how do you say??
Omni Potent? In multiple INDs..
The good Dr just has to jealously chase the safety profile
And lock down PK mode and we are all
Millionaires and the good Dr a billionaire.
Breathe everyone, Alzheimer's may not even be
Our primary IND at this point..could be PArkinsons or MS or
Early CNS deterioration, or Insomnnia!
But honestly for those of us that have weathered the storms
Please don't question the good Dr s motives
. You may disagree with his puzzle structure but you
can't even see the pieces nor the picture
On the box.
God Bless you good Dr! Fight on!
Page 1 of 2 of Article in Forbes by John LaMattina about new Alzheimers Drug.
Only it's not new..it is yet another FAILED REHASH..
AnavexNOW!
http://www.forbes.com/sites/johnlamattina/2016/10/07/a-little-known-drug-company-could-have-the-answer-for-some-alzheimers-patients/2/#3c78b9244a66
A Little-Known Drug Company Could Have The Answer For Some Alzheimer's Patients. By John LaMattina!While many rightfully worry about major health issues such as heart disease, cancer and drug resistant infections, the biggest looming crisis could well be Alzheimer’s disease (AD). As baby boomers get older, more and more will suffer from this disease. Yet, other than palliative treatments such as Pfizer’s Aricept (generic name: donepezil) and Allergan’s Namenda (memantine), which only stave off AD for a relatively brief time, there are no drugs available to halt or reverse this crippling disease.
The dearth of AD drugs isn’t due to a lack of trying. Numerous companies have sought new treatments but greater than 99% of drugs that have entered clinical trials have failed. However, there still are two promising compounds in late-stage development: Lilly’s solanezumab and Biogen’s aducanumab. Solanezumab is an injectable antibody designed to bind to and promote the clearance of the beta-amyloid protein which forms plaques around neurons of people with AD. To date, clinical trials with solanezumab have been disappointing, but Lilly believes that its ongoing late-stage trial will show the benefit of this drug in enhancing cognition in mild AD patients.
Early-stage clinical studies of Biogen’s aducanumab, also an amyloid-targeting antibody given by injection, showed promising reduction of beta-amyloid in the brain in a dose-dependent fashion. Biogen is rapidly moving its drug into late-stage trials. However, both antibodies pose the risk of vasogenic edema (amyloid-related imaging abnormalities or ARIA-E), which could limit their ultimate use and/or effectiveness.
Trying to compete with these large players is Alzheon, a small biotech company in Framingham, Mass. At first pass, it looks like Alzheon has little chance in making a difference for AD patients. It is developing ALZ-801, a prodrug of an old compound, tramiprosate (homotaurine). Tramiprosate was taken into late-stage clinical trials by its originators, Neurochem/Bellus Health. Unfortunately, tramiprosate did not meet the primary outcome goals in phase 3 and the compou
1. Development and approval of amyloid PET imaging–this has shown that clinical diagnosis of AD in mild to moderate AD patients is not accurate in up to 30% of patients (who do not have brain amyloid pathology on amyloid PET imaging).
2. The rate of negative amyloid scans in mild to moderate AD is highest in APOE4/4 non-carriers (40%) and lowest in APOE4/4 homozygotes (5%). Thus, inclusion of APOE4 non-carriers in the earlier pre-PET imaging trials of amyloid-targeting drugs like tramiprosate resulted in trials very unlikely to succeed.
3. With amyloid-targeted agents, it is critical that intervention occurs at the early to mild stage of the disease to demonstrate slowing of disease progression. Intervention later than this is probably too late.
Thus, Tolar believes that a trial can be done to optimize the potential for success. It should be noted that tramiprosate also had issues in terms of variable pharmacokinetics and brain exposure along with poor tolerability in the form of nausea and vomiting. However, these problems seem to have dissipated with a new form of tramiprosate, its valine prodrug, ALZ-801.
Continued from page 1
.
So Michael J Fox Foundation should be finished with Treated In Animal Study, Wonder if they will release final data or just announce the recruiting for PHase 2/3?
Agreed that Ariana was most certainly part of Biogen deal. Stock Option s to key employees was part of deal as well. Why give stock options to Material Handling Agreement if no value to Company? Not like Axovant, where it's CEO's Family getting options..
So the pieces to the puzzle are Small Patient Population, rigorous Data Lines redefined and retested. New info on AD Patients also allows for greater Stratification of Patients(perhaps 3 Groups).FDA in on design team..Data continues to flow in to Anavex..You know the problem with Alzheimers..is you forget how precious every extra day is as it's not like Cancer, your family member doesn't just die with failure, they just fade away..We've got to get this drug on the street..NOW.
All this to show a definitive reaction..
However..Playing the Piano and Painting a picture are pretty doogone
definitive to me..and their spouses..
Fuerstein, Renauer, et al are Big Pharma Hacks who sold their souls a long time ago..sh well....
Will Volume surge continue in early morning trading?
BIOGEN, Michael J Fox Foundation, FDA grants Co. multiple Orphan Drug Status, Trial Design Experts Engaged right after BIOGEN deal, announcements of up to 4 Phase 2/3 Trials-ALzheimers, Parkinsons, RETT Syndrome, & New IND- A3-71 Developments? Pain Killer Developments? Cancer Developments?
New IND's? Eyes? Heart? In Licensing Agreements?
Maybe the Volume Surge at teh end of yesterday was not that big of a deal..
You know, when you have Biogen and the Michael J Fox Foundation ACTIVELY working with you to treat Multiple Sclerosis and Parkinson's Disease, you get a little more respect. The Whale is going to swim away with a lot of short sellers money..a lot of their money. At least 5 market makers will bite the dust when Anavex is in the belly of the whale, maybe more.
Anavexnow, I am having a hard time sleeping and I don't want to be drowsy.
Thank YOu ,,thank You very much...
http://ir.regenxbio.com/phoenix.zhtml?c=254175&p=irol-newsArticle&ID=2168467
Maybe after the Material Agreement, Biogen has something like this in mind for Anavex..I'm game..
Corey renauer did not disclose Motley Fool's position in Biogen until AFTER he began bashing Anavex.
I am all for suing Motley Fool. They have been despicable.
millstons, eloquently stated..I have been involved in NDA discussions with multi-billion dollar co. and just as you say..to make a Public Announcement,
it's not just ..hey test this for me to see if works..thanks buddy!
like i said earlieer..they have come to terms with success..
CO NOT SELL YOUR SHARES..
oh well
The Dilution Argument is non-existent, period.
end of story. it is effective as short and distort but
at this point, at this price.dilution is irrelevant.
the good dr. has delivered MJFF and Biogen and a
firm to delineate the data from ongoing Phase 2a to craft Phase 3 for
success.
He might be workign around an insomnia quick study as well..
How hard would it be to enroll Insomnia Group?
Guys and Gals the point is simple.
We have a drug that has a CLEAN SAFETY RECORD..
NO SIDE EFFECTS TO SPEAK OF..EASY TO TAKE(Pill Once a day)..
You could use the doggone thing as a Placebo pill.
AND you have all of these positive side effects being observed..
This is a general Population pill..
are you getting it? is this hare to fathom?
it's the new aspirin on steroids..
they are talking you into selling them gold for pennies on the ounce..
Biogen comes in and people are selling because professinal sheisters who don't care about you are telling you to be scared?
reall it's unbearable to watch..
Accumulate
So BIOGEN is in the picture..
Michael J Fox Foundation is givng big preliminary thumbs up..
2 questions for all you brainiacs selling ..
1. Who was selling you the 25 Million Shares on Biogen nes at $4?
2. Who is buying the shares of Anavex at $3.25?
Hey..do you think it's the same people?
this stuff is hard to watch..Accumulate..
the Payoff must be close ..shorts are scared into panic mode..
the dilution scare..it's unbearable.
meaningless announcements? BIOGEN?
IDIOTS!
Accumlate
So BIOGEN is investing millions to test a drug for MS? FACT
MJFF is going to move forward with Hu Testing for Parkinsons.(IMO).
THE FDA is guiding a Phase 2/3 Study..FACT
ALL Billion Dollar markets , ill served..
and Anavex is not worth a risk? hmm..
must be a lot of stupid people at Biogen..