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Biostock, again thanks for the amazing work and effort to support us here. Can you close the loop around A2-73 and the concept of restoration of CNS cellular homeostasis for me. I understand it must be right on the tip of your thoughts. That concept has me hooked on this company. TIA. Is that where this all ends up?
Biostockclub: Brilliant, sensible, rational at the same time. An impressive body of knowledge with hard work of connecting the dots at the highest level.
Biostockclub:
Biostockclub...you da man...made my week...best news ever...thanks..
Does anyone else think it is strange that a compendium of the worlds CNS disease collective genius in regulatory bodies and academia, BP, clinics etc would not recognize an effective treatment for AD(and other CNS diseases) if it reached up and bit them in the arse?
If you think I did not cut you, try to move your head.
Xena:
treden:
Excellent Xena, thanks for the link...this is probably where all of the AD discussion will go next/eventually.(IMO). while we are here, we might as well understand what the future looks like. It is really unclear if there will be an AHHHHAAA (Fleming moment)w/AD. Maybe the breadcrumbs evidence trail will take a while to build. Looking fwd to some meaningful WW AD metric which links more directly w/QOL in a meaningful way. Having meaningful studies of A2-73 in this context would be a definite step forward.
Unclear if any kind of retrospective evaluations are possible yet.
https://bmjopen.bmj.com/content/8/3/e019082
Some people who have already started the QOL db. Looking fwd to AVXL being involved w/this. IMO, from a patients point of view this is really all that matters.
If this is not the bottom, you can see it from here. Stand by.
https://www.movementdisorders.org/MDS-Files1/PDFs/Rating-Scales/MDS-UPDRS_English_FINAL.pdf
link provided by Xena. PDD trial measurement criteria appears to provide an array of movement and other criteria (functional testing) which should provide more easily measured outcome. The fact that AD patients for (up to) the first 2 years w/minor cognitive indications gives early results for PDD an advantage in timing and certainty IMO. (being more certain, sooner). The thought was that my be why he chose to go there first. I could be way wrong but if not, it makes sense.FDA has documented they are uncertain if stage 1-2 AD even exists.
Just a thought.
Goodsaid has done a lot of work w/FDA and on PM apps.
Who was it that said..."First, kill all the lawyers."..?
ACTC investment is long overdue. The program outline shows clearly they will spend money to set up a set of basic controls and infrastructure which one would expect was basic and already in place. Good news is, they are starting to address the public need, the bad news is they are way late and the investment is (according to simple math) is a little light at roughly $2.64 per current/projected 5 yr AD patients per year. So, good news is they finally are starting to put resources in place to address AD national needs. Bad news is the program is underfunded and below the radar.
I think I got it, but thanks anyways.
After years of relative news starvation we are now entering a period of information abundance, AVXL STYLE. Not only were we told abut new trials but we have evidence they exist and are progressing. The dilution/sky is falling suicide bombers have taken a detour. Speculation on 7B$$ AD scope or whatever is being debated. Our current sp is off by a factor of $100/share, we say w/straight face.
So, we are HERE, wherever that is. I suggest that the body of AVXL technical/business knowledge on the collective iHUB MB is greater than any other outside the wisdom of AVXL SAB. When we catch our collective breath lets set some sp reality goals. I am starting at $XXX as the minimum before I start to take something off the table but do not want to get too far out in front yet.
Time to stand back, relax a little before the next crisis.
Thanks...you're the best...
Abel-Cabel...thx for the link on PDD.
https://clinicaltrials.gov/ct2/show/NCT03774459?term=ANavex&rank=2
Do you have any additional information about what these tests involve??TIA.
Dr. M.'s heavy emphasis on AVXL Precision Medicine "UNIQUE" trials got my attention. Would be nice if somehow the FDA expressed similar enthusiasm, Swiftly would be good.
tredenwater2
Also, Can we agree that Swiftly suggest faster movement than soonly? Done.
11:30 AM
Precision Medicine Approach for Treating Neurological Diseases via Sigma-1 Receptor Activation
Speaker
Christopher Missling, PhD
Anavex Life Sciences
PM key words the FDA wants to see/hear in a forum like this one. Hope this is linked to others that may follow in other forums. FDA processes do not exactly turn on a dime. Am looking for big upfront investigation resulting in well defined early results. Not your father's Oldsmobile. Hope he points out that the days of spend a lot of money for trial and error problem solving are over. We may get hint today from this. No doubt the true meaning word analysts will bless us w/interpretations galore. All the best.
Does it strike anyone as strange how many personal shorter models for clinical-micro-biotec predictions are based on past 10 years of examples? The problem is, The FDA has just blown up the entire set requirements and scenarios under which they will consider various approvals, including conditional use approvals. (read up on RWE/RWD) No one is saying yet what will happen b/c we don't know yet. What is pretty clear is that the previous stage level model II/IIIa/b, etc are NA. Even the FDA has stated that the rules have changed. They also now have included RWE/RWD b/c the old process produced NADA/Ziltch/bupkas. So the old do or die catastrophic change thinking driven and controlled by BP and who knows what else has been blown up and no one has a clue what will be the next decision process (make or break) model is. WE'LL SEE I guess, or my personal favorite SOON.. If we get good results quickly (3 trials) the whole world will know overnight. The man keeps talking about establishing CNS cellular Homeostasis ya know.
I suggest the hackers/shorters who are basing their projections on last years cycles model are at risk. The fact that some trials are going to be done in EU and Australia will also complicate the prediction process. And, the last-biggest variable is the scope of any success (say based on claims of effective treatments for any CNS diseases, exponential changes all linked) adds an exponent to all calculations that is impossible to estimate rationally. Never been done, standby for the cycle disbelief/denial, acceptance and testing, internalization of the scope...diaper changes all around. So keep on saying how lousy AVXL is as an investment...ask T-38 Falcon what you must do for a flameout on short final, b/c that is going to happen.
https://alzheimers.com.au/our-work/current-clinical-trials/
OK, here's the plan. You can either take daily tablet or you can have a monthly intravenous injection of this chemical which we think will combat plaque.