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IF you believe that Anavex has the FIRST DRUG to EVER show Cognitive Reversal at ANY DOSAGE, than whether or not AAIC will give them the FLOOR is lacking any logic..They will give ANAVEX the KEY TO THE DOGGONE CONVENTION HALL! Man this crew is BEAT DOWN
the PK data released after PART A was after 24 DAYS of dosing from(with off period of 12 between). Any seriously positive PK Data shown for PART A would have been expected due to computer modeling, but NOT EXPECTED DUE to 99% FAILURE RATE of Alzheimer Drugs. SO..when PART A Data showed such striking linkage to Dose Response in such a SHORT time frame, the REAL PK became PART B 12 WEEKS..It would have been nice to see Ananvex include 12 Weeks in the title..but Anavex is fighting a WAR ..and right now, shareholders are the front line soldiers..WHY WOULD Anavex RE-HASH OLD PK DATA at AAIC? This would be terrible management, and the ONE THING WE KNOW..IS..we have GRRRREAT Management..SO Ipso Facto, Quasium ad Nauseum,Blinko Gingkorum,..PK 12 Week is AWESOME..
good work frrol
if you nbelieve in Anavex and the good Dr. BUY MORE, if you are here for trading purposes, chances are you are going to get slaughtered because either way , for or against, you will be competing with the HOUSE(Market Makers). Remember..just REMEMBER what the good Dr. has already accomplished is worth 5 times the value of the price RIGHT NOW!
as George would say..Good Luck
cAREFUL is what you are reading..
I would take A2-73 in a heartbeat, a brainwave, any other movement you may think of that involves a Major Organ and a Sigma 1 Ligand!
This is me being cautious..
for goodness sakes people..Human beings drink themselves to death, put cocaine up their nose to get high and then die..
like I SAID..
WHO is NOT GOING to TAKE THIS DRUG?
If i could buy it..I would already be on it..
Another piece to the good Dr. Puzzle with Fragile X..
beautiful!
miraculous!
curative!
WHO isn't GOING TO TAKE THIS DRUG?
We are Blessed beyoond words..well..
the WORD did come first..so..
thank you..now that you mention it..the horse really hasn't moved for quite awhile..haha
So Miss Australia has given her opinion as to whether her family mamber is cured..and the answer is no..from past posts we know her family member is getting better, but perhaps they have reached a platueau..it is possible and hopeful , that the longer a Human being takes A2-73 the greater teh Curative Effect..but ladies and gentleman..remembering what one could not before taking A2-73..Doing things that one could NOT DO befroe taking A2-73 are BOTH CURATIVE responses..REMISSION of SYMPTONS..
Now..NO PROGRESSION is not CURATIVE but in the case of CANCER AND ALZHEIMERS and pretty much ANY DISEASE..not getting worse is Succesful Treatment..Maybe not CURATIVE, but SUCCESFUL..
In either case..
WITH the DATA we already have..With the STANDARD that the
FDA has set with the Choice to APPROVE Bemacyclib from Eli Lilly for
BREAKTHROUGH DESIGNATION..
AnAVEX BY EVERY MEASURE MORE THAN QUALIFIES ..NOW! for
BREAKTHROUGH DESIGNATION..
oh qiat..so everyone can feel good about this post..imHo
not worried about where stock goes price wise..
let's get this medicine to the Patients..
everything else is a bonus for Anavex Believers
Miss Australia, you were the first to give us an open and honest feedback as most as felt comfortable. I appreciate your words and privacy.
But would you consideer the Piano Player, the Painter(dojng her own Art Show) as cured? Living like they were before the disease took everything away?
a post of reason "many moons" thx
the FDA has set a standard for BREAKTHROUGH and A2-73 CRUSHES IT.
Let's not give them an out..let's demand the same treatment..
josh ..the DATA ALREADY Public is ENOUGH to start the Campaign for
BREAKTHROUGH DESIGNATION..
Absolutely! Almost DOUBLE response of new Eli Lilly Cancer Drug that received Breakthrough Desgination..
IF 80% is Curative and I wonder if other 20% of respondents have STABLE Alzheimers? That would be a 100% Response Rate ..
We never saw thost numbers at 5 Weeks..
gross is what the Market Makers have done to this company's incredible Curative new Drug..
the DATA backs me up 100%..what backs you up?
yeah..that is what I thought..
I wonder if the 20% of 5 week Patient population had
"Stable Disease" which would equal 100% Response Rate..
hmm
gud info..thx
give me a break..what is "IS"?
the ONLY data that may NOT be "AVAILABLE" is 12 week PK..
You don't need that DATA to Confirm Breakthrough or Deny Breakthrough..
You have ALL THE OTHER TESTS and you have had them for weeks..months?
i grow weary of pointing out the obvious..
the Anavex trial is OPEN. They HAVE the DATA, not just for 12 Weeks but for 26 weeks, interim 38, interim 52..heck they already have some beyond 52 week data probably..it is an OPEN TRIAL..when they do the Tests THEY HAVE THE DATA..put it in the computer..send it to FDA ..NOW FDA has the DATA.
The PK data is important BUT the PK data that was MOST IMPORTANT we already HAVE! There is ACTION at 5Mg, significant ACTION at 14 Mg and not a major diffrence in respnce between 30Mg and 50Mg. THAT IS PROBALY not going to change..right?
They have the DATA they need to Proclaim Breakthrough..RIGHT NOW..
The NUMBERS are NOT GREAT ENOUGH, n-=32 is TOO SMALL.
"We don't have enough data, playing piano not enough"
blah, blah, blah..
Wrong, Wrongk, Wrongker.
The FDA just designated a Drug Breakthrough Designation after
PHASE 1. IF the Science is PROVED as a BREAKTHROUGH ..Designation does NOT NEED to WAIT for PHASE 3..Says THE FDA..
Don't want to bore you but at 5 Weeks we had PK Confirmed..starting at 5 Mg of dosage..and at 5 weeks we had almost an 80% Curative Response-Succesful Treatment.as around 25 of 32 Patients averaged improved response(not stable-but Curative-getting better)
The FDA just designated the same Eli Lilly Drug Abemacyclib "Breakthrough" after ONLY a TOTAL 13 PATIENTS showed SOME Curative Effect..Partial REMISSION(did not appear per the news any Full Remissions). Other Patients showed NO PROGRESSION-which in Cancer(like ALzheimers) is considered Succesful Treatment.This total along with Regression Population was
The investigational anticancer therapeutic abemaciclib, which targets CDK4 and CDK6, showed durable clinical activity when given as continuous single-agent therapy to patients with a variety of cancer types, including breast cancer, non-small cell lung cancer (NSCLC), glioblastoma, and melanoma, according to results from a phase I clinical trial
Radiographic responses were observed for some patients with breast cancer, NSCLC, and melanoma. Among the 36 patients with hormone receptor-positive breast cancer, 11 had a partial response, with four of the 11 responders having continued prior endocrine therapy, and an additional 18 patients had stable disease. Among the 68 patients with NSCLC, two had a partial response and 31 had stable disease; one patient who had a partial response and 12 who had stable disease were known to have KRAS-mutant NSCLC. Among the 26 patients with melanoma, one had a partial response and six had stable disease. Three of the 17 patients with glioblastoma had stable disease, with two of them continuing to receive treatment without disease progression for 19 and 23 cycles, respectively..
Total of 147 Patients listed above: Respnse Rate
14 out of 147 had PARTIAL RESPONSE.= 9.5%
45 out of 147 had STABEL DISEASE = 30%
Overall Response Rate of 40% in PHASE 1 = BREAKTHROUGH DESIGNATION
So by the numbers Anavex has at LEAST 11 Patients showing CURATIVE Response-Higher Scores on ADCS-ADL. If YOU go by 5 Weeks data than A2-73 shows Curative Effect on almost TWICE as MANY PATIENTS as the Abemacyclib that just GOT FDA Breakthrough Designation. AND if you go by a Percentage of Population responding VS straight numbers..well A2-73 Respnse rate at 5 Weeks and interim 12 weeks on a PERCENTAGE BASIS is near 80% or TWICE the response rate fo the Eli Lilly Drug that just GOT BREAKTHROUGH DESIGNATION. So ..Anavex is going to Breakthrough because teh numbers don't lie..
premature are we? am I?
I full heartily, adamantly disagree.
here, let me play you a tune, or paint you a picture. Well, you
are right they are not CLINICAL proof, because they left the clinic to create and promote their own art show..of new art..you don't really do that sort of thing in a Clinic..now do ya'?
11 of 14 Interim 12 week +3.21 Average..We already KNOW wwe have 11 Curative Respnse Patients..Don't we?
ONLY 13 out of 147 Patients showed Curative Response in Eli Lilly cancer Drug..FDA Response = BREAKTHROUGH DESIGNATION!
Per Activity at 8 Months, we KNOW 3 Patients "CURED" by engaging in ACTIVITY that ONLY A CURED Patient could complete..
So..that is ALMOST 10% OF N=32..That is around % 9.5% of Eli Lilly Cancer Drug that showed Curative Effect and received Breakthrough Designation..
BUT here boys and girls and frantic, chronic panty wetters is what is REALLY going to get you in a pinch so to speak..
The almost 80% CURATIVE EFFECT shown at 12 WEEKS that we KNOW should automatically give US BREAKTHROUGH STATUS..That is what I am waiting upon..
the rest of you will just be delightfully surprised..
Before you may Cure something..having your drug show a CURATIVE EFFECT.wit PK Confirmation..well..I am just not as slow on a comparative basis as my tests showed..Thank the Lord!.
do you see at the end of the LATEST Motley Fool Joke Piece..
Motley Fool recommends BIOGEN..
Covering their ARSE..wonder IF Motley Fool ALWAYS DISCLOSED THEIR
Biogen Endorsement? NOT
: something (such as a drug or medical treatment) that stops a disease and makes someone healthy again
: something that ends a problem or improves a bad situation
: the act of making someone healthy again after an illness
i was right..First Line
so being "Curative" in action we may all agree that Anavex has proven to be "CURATIVE" or to have shown "CURATIVE" properties for patients..
There can be ZERO ARGUMENT that moving UP on testing scales and re-doing incredibly complex actions that were "ceased" before Treatment, definitively fall under "CURATIVE ACTION". So if one No Longer elicits the SYMPTONS of a Disease, neither in action or through non-action/knowledge we may call them "CURED". Now if the newsly "CURED" Patient must continue to take medicine to prevent becoming sick again..
We do NOT SAY..they are STILL SICK..we say..Unless YOU CONTINUE to TAKE THIS MEDICINE you will become SICK..Hence, at the CURRENT TIME..
YOU ARE CURED..
the point is ..just because you have to continue taking a medication that cured you, doesn't mean you are not cured..it just means..you want to
STAY CURED..
here is my point regarding PK everyone and try to follow along..
PK as my simpleton mind understands is mainly designed to do two things for the Dr.and Co.
First PK is supposed to determing if the Medicine is ACTIVE..does it create postiive or negative reactions when introduced into the human body..
SO WE KNOW THAT PK ANSWER IS ..YES
Second PK is designed to GIVE the Trial Director the best possible understanding of WHAT DOSAGE may make the most sense..At what Dosage does ACTION Begin at what dosage does ACTION/REACTION Level off..
So WE KNOW THAT PK is 14 Mg minimum, 50 MG Maximum.
this can be narrowed..but
As best I can understand it..WE HAVE THE TWO MOST IMPORTANT PK Definitions ALREADY..WE KNOW THEM..12, 26, 38 52 , 104, 156.
THE PK may change HOW it continues to effect..but with
little to no ACCUMULTATION in SYSTEM of A2-73..it is probably a SAFE ASSUMPTION(like there is such a beast) that the PK ACTION remains relatively constant..
WE KNOW WHAT WE ARE WAITING FOR ..and IT IS BRILLIANT..JUST BRILLIANT
xena ..love ya..but do you read your own writing?
"reversal of progression"?
I don't have a dictionary in front of me..but I think we can all agree on the lines under
being CURED..is reversal of progression of disease..
honestly..not to be that guy..but
I am thinking it is the first definition listed..
abemacyclib showed curative effect upon 13 of 147 patients(not one cured)
A2-73 at 12 Weeks showed curative effect upon 11 of 14 Patients..
at 8 months it appears at least 3 Patients Cured..
Breakthrough Designation for Anavex Now!
Not one single post on Amemacyclib?
Breakthrough Designation after PHASE 1 !
Breakthough Designation with Under 50% Response Rate. !
Breakthrough Designation with under 10% of Patients Getting Better !
Am I RINGING ANY BELLS YET?
WE ARE SLOW TO UNDERSTAND WHAT WE HAVE BECAUSE OF THE
MM SHORT CABAL..
Extricate, Re-Process, and ATTACK!
WE DEMAND BREAKTHROUGH DESIGNATION!
100% DISAGREE..The RESULTS are NOT AVAILABLE..does NOT mean they don't have them..it is OBVIOUS by TIME FACTOR ALONE that THEY HAVE ALL RESULTS..
It is an OPEN TRIAL..
In an Open Trial the point is to KNOW the Data AS it becomes available. the good Dr. knows everything BUT PK CONFIRMED DATA..the good Dr. knows the first looks at how every single PK Dataset has been analyzed-IMO-the reason the good Dr. does NOT have the Dataset to RELEASE is BECAUSE it ..the PK Dataset is still being CONFIRMED by 3rd Parties..FDA, BP, and perhaps even ANOTHER 3rd Party Lab..IMO..So with THAT being the assumption..there are MANY < MANY people who know uncoirmed PK and ALL OTHER 12 WEEK and Most of 26 WEEK data..IMO..The ONLY REASON that it could possibly be taking this LONG is to CONFIRM UNBELIEVABLE DATA..HENCE WHY you SEE teh FDA SHOWERING THE LOVE upon Anavex..SHOWERING..The FDA KNOWS..Anavex KNOWS..And WE , as BELIEVERS in ANAVEX..KNOW..
This dataset CAN NOT BE RELEASED UNTIL Phase 3 is Funded by __________? and accepting applications...AND as much as I want to see Anavex go straight to $95 a share or more..SOMEONE MUST NEUTRALIZE the MM Short CABAL..
Either LEGALLY, or with a BP..BEFORE the 12 Week Dataset release..
remember awhile ago when doing Juice Plus..that
something like 70% of all human disease start in Digestive Tract..
Look the ONLY data that may be "unavailable" to the "good Dr." IS PK.
Since all other Data may be tabulated relatively easily in an open trial has been available to the good Dr for months...the only Data to which he refers is the PK data..and you make a good point..How could FDA and BP review ALL the Data without that data set being available to Anavex?
My answer is : Anavex sent PK data and all other Data for Third Party Confirmation and Review to FDA and BP to consumate Phase 3. Neither of these parties would release Anavex from disclosing Data whilst they are "Confirming" it...so therefor ergo..the Data is NOT AVAILABLE to Anavex.
NOTE: the good Dr. didn't say ..I DON'T KNOW THE DATA" just that it is Unavailable..Please..
SUCCINCTLY PUT cLOSET.
N=32 is a small number..but...if as many of us suspect, the delay in confirming the Data Sets are mainly to do with the reactive incredulousness at their success, both from FDA and BP..
I think what is being planned is an EXPANSIVE Phase 3, designed to quickly (within 12 weeks) to be opened for Compassionate Care and the Placebo group given medicine..
The Rett Syndrome would make A2-73 available for Cross prescription for those following the Phase 2a PART B continuing Data stream..
Yes Snark You win the booby prize of logic rather than frustration!
Not only would they have seen 12 week, but probably 26, 38 and even 52 for ADCS-ADl for Interim or some of the patients..
but hey..logic for most is way overrated, when they know what they knows..logic may confuse them with the facts..
Time is a precious thing in this WOrld..those who
don't believe in Anavex have a curative treatment should really invest their time elswhere..Anywhere..really. The curative effect of Anavex is in a painting, or a song or a 10 footer that slides in the side door..
Why are you wasting your life posting and following something in which you do not believe. Move on. Life is short.
the key will be..
WHEN the DATA proves CURATIVE..to make the Cabal PAY..
ok..
so..Quiet Period..
FDA..Shhh
SEC..SHHH
BP Partner ..shhh.
DATA from OPEN TRIAL with SOME of the Data still being processed..
Shh..
Quiet period is what the Short Sellers are praying to hell for..
Sorry..I didn't mean it as a Financial Term..
I meant it in a
Cosmic, Anavex is about to REVOLUTIONIZE the WORLD TERM.
Reyeton GREAT POST from Adelaide!
Beautiful.
The FOOL trying to cover SHORTS LONG< LONG Weekend fo worry..
What if the Art Show goes well?
WIll there be another Piano Recital?
Heard someone might make the PGA Senior Tour?
Hit Man Renauer chokes up another flugie for Hope!
Remember this is the guy that Barked Down the Street
chasing a Phase 1b Biogen Positive for $29 BILLION..only to see the
Biogen train derail..and then back up..OUCH..$29 Billion!
the famous Renauer motto:
Corey can show YOU how to become a Billionairre!
You just have to call him when you are worth $30 BILLION!
not too much before that though..really..
basparks..i have reviewed this ..it is published data..
THe Placebo Effect trails to near ZERO at 12 Weeks..i have written on this before..at 5 Week- Week the Alzheimer Mild to Moderate Population may show
the SAME Positive % EFFECT as Aricept but this SAME Blind Controlled Placebo Group that showed Placebo Effect at 5-6 Weeks is GONE-NADA-ZERO Placebo Effect or REMNANT of Placebo effect at 12 Weeks..
That is WHY Interim 12 Weeks is SO POWERFUL..it DESTROYS or SHOULD DESTROY and FEAR Longs have of no Control Blind Placebo Group..
BUT the MM SHort Cabal is NOT GOING to support this Company in the Market Place..So until we have a BP Partner..the Traders and MM Short Cabal..are hard to stop..