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Anyone who has ever been in a conference room where science advocates duke it out over points or argument they each hold as religious artifacts will recognize where we are . BTW, there is NEVER a clear winner in those confrontations...but it must be done anyways.
The learning process is getting down to the last few finalists , do not expect a clean winner yet (AVXL VS XX, VS ZZ). Trust that at some point this to will pass and the process of learning will carry on. Possibly even some interim hybrid symptom based solution. The process does work .
The learning process will evolve (se Dr. Peter Senge models) , even though it can be tough. The real facts and solutions may already be on the table. I think so or will soon be. I do strongly see the AVXL upstream MOA as the final resolution winner. We are possibly even there now and only need a few final CN-system refinements.
XODCODE
georgejjl
Remember this b/c it will be quoted a lot in the next few weeks.
Plexrec
plexrec [quote"Now set DEFCON II"--green is so much nicer to see than red !!!!!][/quote]
We are either READY ...OR ....WE ARE NOT...it has to start some time...IMO...DR.M. will take the point when he sees the time is right.... We did not come all this way to back off...
Musashi ( a famous Samurai) had a saying..."When a warrior is in battle, he must fight as though he was already dead." ... Are we ready , or not??? Yes, we are and the world is about to benefit and to understand.
11.64+0.49 (+4.39%)
As of 10:05AM EDT. Market open.
Now set DEFCON II...hostilities are immanent...standby
Kentucky 123
Jonj325...
GOD BLESS THE LEAKERS, ONE AND ALL.
plexrec
plexrec:
https://newsfilter.io/a/3948a42a9d258aeb292507953b1d91b4
attilathehunt
"I want to see some intra-day conviction buying."
Hopefully tomorrow!]
Xena
What does this chart say?
"We want your shares REALLY BAD"
Agree, the slight bounce near the end of the day was a clear signal...of OOOPS...they REALLY DO believe...WGT.
Boopka ...Excellent post ...thanks .
My experience is the very best companies are built on two principals ...Competency and trust....both of these qualities are demonstrated (as you describe) by the actions of Dr.M. and the AVXL team. The very best teams will value and demonstrate these qualities even when the chips are down...they will each have each-others back also.
Let's not mistake any of these as mistake proof (they are human). They are developing what eventually comes to be known as a corporate culture which only the VERY BEST can perpetuate. (being a liar gets you fired) This process takes decades . Mercedes comes to mind as a possible example. IMO, owning a share is more than owning stock.
Xena ...you go girl...bless you, value and appreciate your intel & knowledge , w/sense of integrity and courage here as a recurring theme.
[IMO - today was a mini pump and dump.
Blocks >=2K
In a neutral to bullish market I expect to resume the upward movement tomorrow.
/quote]
well done
growinpain
They have been in talks with the editor of the journal and have secured a fast-track review process.
Anyone hear about a meeting or PR scheduled for Tuesday?
TIA
abew4me
Four Programs Exist to Expedite Drug Development for Certain Types of New Drug Applications (Guidance for Industry Expedited Programs for Serious Conditions – Drugs and Biologics, May 2015)
Fast Track Designation FDAMA /FDASIA 2012
Breakthrough Therapy Designation FD&C Act/FDASIA 2012
Priority Review PDUFA 1992
Accelerated Approval 21CFR314 subpart H, 601 subpart E/FDASIA 2012
Game time...What color is this RED piece of Paper??
Gator328
We can infer the data is positive from the fact Avanvex is presenting at CTAD, the lead researcher is flying across the globe to present the data, and that they're having the data peer-reviewed and published -- but just how good the data will be remains a mystery to all of us and predictions are simply a parlor game to pass the time until 12/1.
Nicely done 30fold...
Blarcamesine at the same time this study was released. Dare I say….another dot.
https://link.theepochtimes.com/mkt_app/health/long-covid-induced-neuropsychiatric-risks-can-last-for-over-2-years-1-remedy-to-protect-or-reverse-the-situation_4725558.html
plexrec
do we have the goods ?? What do you think ???
tredenwaters
BIIB presents before the opening introduction on the first day. As if it is an actual “breakthrough” in AD treatments. These conferences sure like to put BP in the limelight.
Thanks Gernee. One AD company uses the media, deep connected GOB players, and advantageous time slots to aggrandize its drug(s) which has all failed in the past.
Anavex has chosen to let the data speak for itself by not promoting anything, not even PR’ing the times lot given at Ctad!
Should be refreshing to most if not all only absent the MC increase. The latter will take care of itself soon enough.
Excellent stuff goergejji...This REALLY IS WHAT AVXL DOES...AND...MAYBE-PROBABLY SOMEDAY...we will be payed for it too...
Anavex Life Sciences is a person-focused, biopharmaceutical company dedicated to therapeutic discovery and development of targeted CNS treatments.
“Anavex Life Sciences is pleased to sponsor the Winter Gala organized by Reverse Rett. We recognize and support the efforts of Reverse Rett because of their great impact on the Rett Syndrome community in the United Kingdom. We are honored to partner with Reverse Rett in our Rett Syndrome drug development program. Collaborations like this are essential for the success of the program and for any effort aimed at improving the quality of life of those affected by the disorder and their families.”
Dr Walter Kaufmann MD, Chief Scientific Officer, Anavex Life Sciences.
https://gala.reverserett.org.uk/sponsors#anavex
attilathehunt
I truly believe our day has arrived. I’m not being giddy. Just real! The culmination of events over the last several years (especially the last year) all point to something substantial about to announced.
powerwalker
I don't believe TGD will give any details
GOT IT:baseparks79
I'm just warning everyone that the AF cabal will very likely have organized a short attack on the initial TLD,
Blarcasmine:
Someone please connect that dot for us.
WOW...excellent post-summary of irons we have in the fire. This kind of (see below)process-research program should be noted as almost the complete opposite of what the FDA have done for the past 50+ years around Amyloid Plaque. We witnessed decades of repeated attempts to prove something that was fundamentally flawed. Not only did FDA waste a lot of time and money but the evidence indicates they did not learn much in the process . Some still do not get that (see SAVA).
Looks to me like AVXL have an opposite possible outcome which we must also be aware of. Let's not confuse ourselves going forward by spinning off multiple solutions, etc, etc. AND, BTW lets get this done in our lifetime.
This will require a lot of smart people showing a lot of strong processing disciplines. True, we have a lot to learn but we do not have a lot of time to get conclusive results.
I do not know about the rest of you folks but I am not getting any younger around here...CARRY ON.
xodcode
So many outcome permutations and combinations make it nearly impossible to predict what AVXL will look like a few months to a year from now.
Falconer has always maintained that 2023 will be the AVXL breakout year and with so much additional news expected between now and year end, it is difficult to dispute Falconer's estimate.
Whether it's partnership or positive developments following news on one or all of the following AVXL expectations:
1. Top-line data ANAVEX®2-73-AD-004: Potentially pivotal Phase 2b/3 AD clinical trial – expected fall 2022
2. Data of 48-week OLE PDD Phase 2 study – expected by end 2022
3. EXCELLENCE completion: Potentially pivotal Phase 2/3 pediatric RTT clinical trial – expected by end 2022
4. Initiation of ANAVEX®2-73 imaging-focused Parkinson’s disease clinical trial – expected 2022
5. Initiation of potentially pivotal ANAVEX®2-73 Phase 2/3 Fragile X clinical trial – expected 2022
6. Initiation of potentially pivotal ANAVEX®2-73 Phase 2/3 clinical trial for the treatment of a new, rare disease indication – expected 2022
7. Initiation of ANAVEX®3-71 Phase 2 clinical trial for FTD, schizophrenias and Alzheimer’s disease – expected 2022
exciting times abound for the AVXL shareholder.
With the large amount of precision data accumulated by AVXL to date, the huge amount of expected news before the end of 2022 and the rather low FDA bars in place exemplified by recent FDA decisions, the AVXL shareholder has much to digest in the coming months.
AVXL has come a long way in a reasonably short time without issuing a huge number of shares (i.e. there are biotechs out there trading for $o.30 with 200,000 shs plus ).
Any success with partnership or any of the outcomes above and AVXL is likely to launch to a much higher price level.
The AVXL risk/reward ratio at $10 to $11 with all the potentially positive news before year's end is highly favouable imo. As a resuly I am very much in the WGT camp!
IMO, SAVA may well be a poster child for what is wrong with WS-BIO PHARMA investing .
TempePhil
We do not know when, or even IF he has the trial data.
11.20 +0.33 (+3.04%)
Pre-Market: 09:06AM EDT
Does this suggest an AB-E-NORMAL DAY IS ABOUT TO START??
11.38 +0.51 (+4.69%)
Pre-Market: 08:18AM EDT
Gerogejji...I hate to be the one to break this to you but...yes AVXL is required to comply w/such basic requirements. How are AVXL able to identify and assess that their suppliers have adequate controls? This is even more important when the CRO sites are WW. Please assess this further. AVXL is a potential drug supplier, these rules apply directly to their FDA-V&V compliance requirements...(or they are a special case?).
Perhaps the recently hired AVXL Quality manager could help explain how this is/has/will be done. Again, not trying to be difficult but this is basic requirement.
Anavex must rely on the trial sites and CROs for quality assurance and control and compliance to best practices.
Please note.
These are NOT....NICE to HAVE ...this is the FED. LAW.
georgejji
I have never heard of V & V used in pharmaceutical drug trials. The concept is good but it would be very difficult to do in practice at multiple clinical trial sites in multiple countries. I believe that selection of trial sites would rely mainly on each sites certifications FDA, EMA, TSA, ISO 15189, etc.
It is fundamental that any labs used must comply w/FDA requirements when the outputs/data will be used as evidence of compliance w/trial end points.
Start w/21 CFR parts 210/211. EX 211.186, Master control of records. ..systems V&V for change controls/training requirements/basics. All of relevant (see scope of work) Lab controls/(subI), Records and reports Sub J, . Apply all of 21 CFR parts 210&211 as directed by an assessment for systems scope and requirements for lab controls. All 21 CFR part 11 (control of electronic records/signatures). Applicable sections of ISO 17025-testing, ISO 17025 competence and testing.
That is just the beginning. These requirements would be fundamental to the qualification and acceptance of any resource used for compliance acceptance. There is a lot more, but suffice to say this is just not the time to have the discussion. All of that would have been completed long before any lab/test resources could be considered for test services w/this level of criticality.
georgejjl
Database auditing and clean up can take months when a lot of data is recorded for each trial participant and the trial was performed at over 50 sites in 5 separate countries on 3 different continents.
Database auditing and clean up can take months when a lot of data is recorded for each trial participant and the trial was performed at over 50 sites in 5 separate countries on 3 different continents.