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great post frrrrrr
A2-73 has been around for over a decade? how many people's lives could have been touched? it is time to become impatient! and this impatience will become quite discernible when 12 WEEKS are announced, affirming the obvious. A crescendo of hope will not be ignored for long. My guess is the good Dr and the FDA are creating a plan to answer the positive tumult.
do you mean March Presentation?
every Alzheimers Drug TRrial until ANavex..
IF the PK data is confirmed at 12 WEEKS and It is highly UNETHICAL and CRUEL to have a Double Blind Placebo Study for ANYONE..
ALL Blinded Placebo Studies should CEASE on ALZHEIMERS as the WORLD already has all the Placebo, Blinded FAILURE Information IT NEEDS to form a knowledgeable comparative.
IT IS RIDICULOUS, HARMFUL, HURTFUL, WICKED to continue to pretend that Blided Placebo Cohorts are Necessary.. They are NOT!
What if the Data Sets are Positively Provocative? What responsibility does Anavex have to tamper down immediate expectations of treatment? Any? A lot? It will be interesting..as Many, Many people are waiting and watching for these results. It reminds me of my first deep sea fishing trip, when I kept asking the Captain if when my rod pulled a little bit, that if this was a bight? The Captain laughed, and told me I would know a bight when I had a bight! So I stopped asking him every time the Rod I was holding would pull a little. The next thing I knew, I was flying out of my chair and crashing into the back of the boat, as the Captain or my Dad, had neglected to make sure that I was strapped. (I was about 10). Let's hope WHEN Anavex rocks out the first and only succesful treatment for Alzheimers, the Good Dr. has the Crew properly prepared. We are not fishing with minnows and the water is infested with Sharks!
You want to know how successful A2-73 is going to be..ask yourself this question..
IF and that is a BIG IF, the SAFETY and SIDE EFFECT profiles continue to be squeaky clean..Ask yourself this simple question..
How many people will take this drug BECAUSE..
And you know I am right..Who isn't going to be taking this stuff?
and when A3-71 comes along..and if it has same Safety and Effects profile..
How many won't take BOTH!
The crossover on this drug once approved for anything is going to be
MINDBLOWING!
Seeing as a Sigma 1 Agonist is having such a positive impact on the Human Condition, and that A2-73 might still take awhile to be commonly available, I researched other Sigma 1 Agonists.. There are many and I absolutely encourage you to do your own research. What I concluded is that DM(Dextromethorphan) proved most accssible and least likely to cause harm-side effects or addiction. If you are taking other home remedy please review their interaction. DM is found in many cough medicines and is Isolated in VICK'S DAYQUIL COUGH- 100% DM. Also recommended is a product called Niagen, which is expensive, but medically proven to be effective.
I simply do not understand the Muscaric Side of the equation, if someone outthere has a similar Generic that might simulate a Muscaric found in A2-73 please share in a message. ALSO, to be CLEAR, the Sigma 1 Agonist found in Anavex 2-73 is NOT THE SAME as DM. As far as I know there only similarity it that they are Sigma 1 Agonists.
PK is Pharmacokinteic..simply stated it is the comparative tabulatio of different data sets that showed ACTION relational to Dose Differential.
This actually is the Scientific Proof that allowed Institutional Buyers to step up their Positions..
Nice to see Ms Australia still a believer! It was two months AFTER 5 WEEK data release that PK confirmation followed. Did anyone here even KNOW that PK was going to follow the 5 WEEK data release? Has anyone here Valued the 4 NEW indications, including Depression and Anxiety, for which Anavex is showing Pre-Clinical checked off? By MY flimsy calculation, that much of Data Structure is already in place for PK, and that this is an OPEN Trial(Data is Available immediately) that the Firm(s) compiling the PK could work AROUND the Clock and finish the PK by next week. If they cut in half it would be APRIL 9th. Time is LIVES so I am cheering for sooner rather than later for 12 WEEK. I am NOT WORRIED about negative news AT ALL. We have all the positive info we need going into this to know WE ARE LOOKING AT GREAT NEWS! 2 Year Extension is ClUE #1! Clue #2 is Interim 12 WEEK ADCS-ADL +3.21 for 11 of 14! Clue #3 is the Good Dr.saying 2 Cognitive Markers showed their best results in February. CLUE #4 is repeated commentary from AVXL that they are EXCITED about 12 WEEK data. CLUE #5 is very simple...Bad News travels fast..If the news were bad..this stock would have crashed...
great post George! Thank You!
Started as a 26 week, than extended to 1 year(now 3 years!) Phase 2a Safety Study. Why Extend it? For Long Term safety? WHy worry about Long Term Safety if NO EFFICACY? Obvious answer is A2-73 WORKS! Duhh!
Pharmacokinetics proven..That doesn't change at 12 WEEKS! If there is ACTION, there is ACTION.
4 NEW Pre-Clinical IND's- Including Depression and Anxiety. Duhh..Duhh..
WHo does this on a $1.5 Million dollar QUARTERLY BUDGET? What ELSE DO YOU BOZOS WANT FROM YOUR CEO? The Good Dr. is orchestrating a masterfully competent symphony to celebrate the pharmaceutical discovery of our lives. Enjoy the Elevator Music while we move higher..much higher!
Great Read Thank You!
2 points: SLide #4 creates multiple new IND with multiple showing Pre-Clinical Validation: Depression, Anxiety, MS, Rett Syndrome, Alzheimers,
epilepsy, / Parkinsons and Schizophrenia are listed but have not yet reached Pre-Clinical Validation.
My second point is the Interim 12 WEEK data showed over 30% of ALL Participants had an OFF the CHART ADCS-ADL reaction of +3.21 ! That was only iwth 11 of 14 Patients reporting..
Any Delay is more likely due to the Revolutionary Success of A2-73 than it's failure, as 80% of the Tested Population showed response as yet unseen!
I am with George on this..the Risk will become too enticing for Investors and they will bid up the shares before close Friday..Traders are getting in now and will book their profits Fri Afternoon..Then we shall see come Monday Morning..Could be the Institutions see enough to buy it higher..Multiple Tests confirming 12 Week Early Efficacy from AD-ADL test..
Investment Value of $360 Million estimated for getting new drug into Patient Population..that puts AVXL at $10/Share..
The Good Dr. keeps his word AGAIN! Two presentations NEXT weekend..Oh My!
TO Miss Australia, God Bless you and your Pop..You are both in my prayers. You owe us nothing and we owe you our Thanks for what you have already shared. For many of us, you helped us through the troubling times of Short and Distort..God Bless!
the Trolls have brought out the LPP deal often..it is not a great deal,,it is the best deal Dr. M was going to get..and hopefully he never needs much of the $50Million..We shall see..
I would think the fact that we KNOW, from preliminary data ALREADY RELEASED, that almost 80% of Patients (11 of 14) at 12 WEEKS showed the greatest response ever seen(this is not necessarily a factual statement, but I have not found any drug that had a better response at 12 WEEKS in previous testing), +3.21 on an ADAS-??? Scale at 12 Weeks..
Why are we regressing to a computer model when we have actual human data in hand? so let's extrapolate from the preliminary 12 WEEK data set, say 23 out of 30 Patients show a similar marked improvement at 12 weeks and then maintain that improvement over 26 weeks..that could be 1/2 a year of independent living..birthdays remembered, stories told, golf played, tea drank with the proper ingredients. names remembered..6 months is forever! As long as the safety profile continues to show minimal risk and only short term minimal discomfort, A2-73 has already shown more efficacy than anything that has ever been tried! And through BIOMARKER Improvement and the nature of A2-73 being preventive, the SOONER people start protecting their brains with A2-73 .perhaps,the better..This is why I think Anavex will release 12/26 WEEK Part B data at the BIOMARKER'S Conference in San Diego, March 22(?)..
No $3 is the minimum price that AVXL may direct LPP to purchase shares and is the post split price..come on..are you trolling? This protects LPP and the shareholders..
brilocidin(?) for Epilepsy : Side Effects include somnolence and fatigue in at least 25% of patients.depression..
or..A2-73 and go play golf..sorry..but A2-73 has some distinct advantages here..
The Rhett Poster is avail at anavex.com, appears the treated Mouse in the last test actually outperforms the Healthy Control Mouse. I may be looking at it incorrectly, but what kind of effect is A2-73 having? Hey Miss Australia, did anybody been reviewing the Score Cards from his Golf? Are his friends wallets a little lighter? Are they still letting him hit from the Red Tees of have they moved him back? Because If this lowers your handi-cap, forget CNS, they will never be able to make enough of it, every golfer will be lining up! And you can count on Golfing Doctors to be first in line!
i get it Miss Australia.People can make money by having the stock go down and your testimony gives many of us extra confidence that people are getting better, so the perception is your words keep the stock from going down, so the negative guys attack you..it sux. Whatever you decide..but I think the "First 30 Down Under" will be historic! And I wish you and your family the best.
Great Post, ANY CNS disease that has previously has Sigma 1 Agonists show some positive effect(probably ALL of them) will want to RETRY with A2-73 and it's Muscaric addition. The computer models are probably going crazy. The MS model didn't indicate what the Computer Models showed..I thought Computer models usually came first?
As long as A2-73 continues a clean safety profile, the Neurodegenerative disaeses that are not being stopped, or cured, will have a much shorter, DRUG cycle IF A2-73 PROVES to be SYMPTOMATICALLY EFFECTIVE. Patients, Families, and Caregivers will demand No Less..
Anavex is pioneering the FIRST TREATMENT to actually show the possiblitiy of reversal of Neuronal Cell Damage by combining the Chaperone Sigma 1 Receptor and Muscsaric(?) ..and we are all not billionairres yet? go figure. People have been getting better for over a year, but that's not good enough? Possibly 3 new Phase 2/3 Studiesto BEGIN THIS YEAR..But not fast enough for all these Long Whiners? Maybe Retail gets what it deserves.
Miss Australia..You already added..because Everyday they are doing well is a gift, enjoy! Maybe the visits can one day be away from the Institution. Prayers.
Hi Miss Australia,
you mentioned you might be on course with a visit to your relative. Any follow up thoughts? Always appreciated...
Thank You Miss AUstralia! I love the Tea Story and the Birthday story. Those are the tidbits of memory, the strands of cognition that highlight the efforts of the Sigma 1 to chaperone the sick brain cells. SO DOGGONE EXCITING! People don't get better with Alzheimers and start remembering things they have lost years ago, they get worse. God Bless and if you have any tidbits from this recent visit, that would be awesome.
Thank You so MUCH Miss Australia! Little things, like how you like your tea? are absolutely BEAUTIFUL! Dr Missling just said that they believe the brain cells are not dead, and that the Sigma 1 receptor may bring them back to health! Would like a crumpet with that Tea? Yeah
Late to ZIKA Virus and have studied it very little, but it appears to attack CNS? Could A2-73 be a protector? or is A2-73 too far from Target and/or just too doggone risky to even consider helping these babies(aka lawsuits?) If someone understands science better please respond..Do not want to lose focus..but ZIKA is a disaster..
How is AXON trading above Anavex? Talk about Market Impurities..
Repeat" As Interim 12 WEEK results show almost an 80% Response Rate(11 of 14 Patients Incl) average of +3.21 on ADCS-ADL Score. Multiple other tests using ARICEPT show.THAT MOST IF NOT ALL?ANY PLACEBO EFFECT IS GONE after 6 WEEKS and 12 WEEK Testing ONLY SHows ACTUAL RESULTS! AVXL IS THE DEAL!
google st. vincents 24 week alzheimer's study..I also wrote DOT where an actual period goes..
After reading Drivan Post where he/she calls for P2/3..we ALL AGREE WITH THAT..Including the FDA! Already announced FDA Guidance for P2/3 happening right NOW to n=32 whose 52 weeks are up? The P2/3 is already announced and being planned that is why $3.50 is so ridiculous..just unbelievable..Should be $10 on it's way to $25..
ok..so I looked at few sites this morning..and upon quick review I know this was one of them..
http://wwwDOTstvincents.ie/dynamic/File/Donepezil%20study.pdf
This shows Placebo group at almost same respnse rate as Aricept at 6 weeks(+1.5) or a lower overall score which is good..and THEN at 12 Weeks Aricept Patients remained close to this improvement level but Placebo Group dropped to +1.(higher score =bad) and then Placebo just keeps going down..the Graph (I can not copy) is easiest way to see what happens at 12 weeks , 18 week, 24 weeks..We will probably see some 26 week data at 12 Week Part B release as well..YES these are small numbers..but they are exciting even if n=32 or n=14..
i will check..
that is a ridiculous statement..it would be cruel not to offer extended access to A2-73 if at 52 weeks Patients are anywhere above Alzheimer's expected Pathline..It would not hurt anything..to do so..what a hateful thing to say..NO YOU CAN't HAVE YOUR DRUG THAT WORKS ANYMORE..WE don't want to HURT OUR STUDY..
in a previous Alzheimer's Disease study ALL PLACEBO effects had disappeared and all those receiveing the Placebo by 12 WEEKS had reverted to the baseline for non-treated Alzheimer's patients on a similar time frame. Shy does this matter? Anavex has already released 12 WEEK Preliminary Data for 14 Patients..and 78.58% show an AVERAGE UNPRCEDENTED increase of +3.21 on their ADCS-ADL scoring.THERE IS ZERO PLACEBO AFFECT AT 12 WEEKS..so ALL OF THIS RESULT is from SUCCESSFUL TREATMENT of ALZHEIMER'S DISEASE! BAM!
I believe each patient is entitled to 52 Extension and accepted, howver, the early Patients will reach or will have already reached thier 52 PART WEEK extension LIMIT. and IF PART B is not extended ..will no longer have access to A2-73. BEFORE this occurs I would expect Anavex to OFFER ALL Patients another 52 WEEK Extension..I just thought maybe I missed it..
I think at lease some patients have come to the end of their 52 WEEK PART B, as Initial enrollee was announced on Dec. 16..So some people need to know immediately whether or not their will be expansion of the PART B.
Has there been any indication of an extension for Patients that are just reaching their 52 WEEKS? ANYONE?