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NWDR...EXCELLENT, informative, rational post. I agree w/everything except for one thing. I believe the dynamics of the communications systems today and the scope(s) of A2-73 treatments along with changes in FDA (and other) regulatory bodies will serve to accelerate change in patient care. We may see concurrent/simultaneous treatment breakouts WW. If A2-73 is an effective treatment people WW will respond quickly on behalf of their patient/family member/other. No need for serial trials, IMO.
I believe the FDA's new mode (RWE) reasoning and the fact that A2-73 has no AE that we are aware of will quickly (read spontaneously) drive a demand process. And, speaking of positive, how about sharing such treatment knowledge WW? All CNS patients WW, regardless of country/politics get an opportunity for treatment are candidates. Yes, a bit of fantasy but not out of the question.
I am hopeful that Dr. M.'s thesis on restored CNS homeostasis restorative/regenerative capability is proven true and that will reduce clinical failure rates from those we have seen till now.
Bottom line, the whole time line for climbing out of the treatment hole we are in will be greatly accelerated.
Now that's a little better.
Volume seems low. Any thoughts on why? Would have expected stronger reaction to conf./new information.
AGD 2...Yep...although AVXL will be continuously challenged, w/good science, these kids will be effectively treated.
NWDR
seven...thx, this data establishes a context to scope the massive dilemma BP has and it emphasizes the potential medical/financial potential of A2-73-AVXL. Not only has there been almost continuous financial investment w/no acceptable payback but medical/clinical results all hit a wall of failure. The whole Tau thing is a dry hole.
In this context the scale and clinical power of restored Homeostasis and it's potential appear to be truly historical importance. In fact no one can say just how massive this is. We will have to peel the iterative process onion of scientific knowledge and discovery.
If all this is true then the holding back of information is either even more puzzling or justified, depending on your point of view. But, if true silence clearly cannot continue.
I sure hope we get the kind of news that matters. If no PR he will be talking about the trial process...hopefully.
IMO, it has been a massive processfailure. Treating trials as stand alone events which are measured by obtuse statistical methods. As I have said before, if the FDA were a fire department they would getting awards for the most chimneys and foundations failed. Only a government regulatory body could get away w/such results. A lot of humans have been suffering b/c of this weakness in recognizing the process is broken. SEE RWE.
Bear...above and beyond as usual. IMO, he is "in your face" confident and he is making a statement about how past trials have been done and what will follow from here. All we have to decide is, is this guy incompetent (no-one/few who has studied his work would suggest that) . He is saying the results are spectacular and you must wait b/c we cannot describe yet what we think we have. It is that good. Trust me. So, either trust him or move on, no hard feelings and no drama.
I'm good with that assessment.
https://www.rettsyndrome.org/file/andrea-files/anavexflyer.pdf
Let us pray for this little girl, her parents and the others. I have limited funds to invest and chose AVXL b/c I would rather do this.
Well done..thx
Will there be an EOD anticipation/anxiety POP? Vote On scale of 1-10 where 10 = certainty and 1 = NFW....I think 8.
steady T..agree completely with your comments. I guess the system is telling us something.
https://alzheimersnewstoday.com/2017/09/22/agenebio-gets-national-institute-on-aging-grant-for-phase-3-trial-of-alzheimers-therapy-agb101/?utm_source=Alzheimer%27s+List&utm_campaign=5da692133d-RSS_EMAIL_CAMPAIGN&utm_medium=email&utm_term=0_94425accb7-5da692133d-72173229.
NIH movement on trials. Some suggestion here on links w/mild Epilepsy and memory loss w/progression to AD. Now where have I heard that before? No comment on trial structure.
We may hear from others before we hear from AVXL or news may be jointly/concurrently released. Connection may not be obvious if this is systemic-evolutionary change.The prospect of Big news from a tiny staff is conceptually exciting but not a realistic expectation, IMO. We should be attentive to any possibly linked events/news from regulatory bodies as indicators of movement which impact the clinical-development environment. Correct me if I am wrong but it seems to me that others are also not announcing much progress/news either. If we are right about A2-73 and AVXL potential then we should expect an avalanche of trial facts/regulatory agency rules news/ business and partnering news, etc. I am surprised we have not already seen evidence of leaks considering the potential. IMO this will not go on.
[I like my anavex conjecture realistic][/quote]
Yes but, breakthroughs do happen. We are realistically standing by for an AHHHHAAAA moment.
I like the bridge analogy as well. We need to be certain that AVXL and FDA are both using the same metrics...not one as inches/feet/yards and the other as meters/kilometers..etc. Some guys built a telescope a while back and then after they got it in orbit they had what must have been the biggest (OH SHAT ) phone conversation ever.
Let's make this a good one.
Avoid setting high expectations...got it.
Excellent advise and generally a biotec rule to live by. IMO, unless and until the FDA clarifies the new rules for trials we need to avoid getting wired up for BIG news.
I am as big an AVXL fan as any but today's basically content free PR sent a message to not be looking for any big show next week. Hope I am wrong but Dr. M. cannot do much until the way forward is clear to everyone. Once that is done ( not sure how it will be declared) then many new trials will be made public for Biotec, including AVXL.
Nice.
Sir...
Is this a new slant ref MJF and full funding?
Bas...agree completely with your thought. When(if) we ever get to understand the whole story behind this set of trials we will see politics, money, science, medical factors and (yes)of course patients are being considered. IMO, W/O Gottlieb/Dr.M. this would not be happening and A2-73 might never see the light of day. BUT, Said different, if BP had A2-73 it would be headlines in all media. IMO.
Dado...thx for your comment. Coming from you this is a really positive input. Best.
roy...helpful post...thx. We know the bias against progress/risk taking has prevailed. Details matter when medical/political demons are under foot.
raja..
Investor..nicely done....an old street expression comes to mind while reading it..."If you think I did not cut you, try moving your head."
T 38...First of all thanks for your service to the country.
It seems from your posts that you at very well informed on the people driving the bus and the mission they are on. We all appreciate your insights. My own read is from a process standpoint. They are driving for changes to a massive system which (IMO) has not served the country well over past decades and which urgently needs change if we are to ever get out of the woods.
I also agree that AVXL and FDA leadership are positioned to accomplish a breakthrough (provided A2-73 does as advertised-Homeostasis in CNS). We sense that this is a first step in a true leadership initiative. I also sense there is more than just inertia holding them back. We ref here how long it took for medical science to understand and apply the benefits of penicillin as an anti biotic compound. IMO, this is a useful analogy to apply to A2-73. Gottlieb and Woodcock have their work cut out for them but as you indicate, they are on a mission of massive urgency and importance. Now that is time well spent.
BTW, U.S. Navy here VS-28 S2, many night traps as A/C. We will be turning into the wind shortly. Stand by.
Just in case you wondered...source
http://www.sciencemag.org/news/2017/04/congress-and-fda-nominee-heap-love-adaptive-trials
reader/User friendly article on Adaptive trials...IMO.dated may be repeat
Anybody else recall the FDA news release about a month+ ago that talked to the new rules and the fact that 4 tests already in the queue? That news said 4 trials test cases had already been approved and were ready to go w/new trials protocol. I have gone back and cannot find it but am certain of what I saw. Anyone else recall? thx