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Sent message to IR asking about PR on qrtly report...when, does timing synch up w/Dr McF's in Aus.? Will post if I get a reply.
Anyone care to speculate on the timing of this event and the U.S. AVXL qtrly. update? Note the use of a keyword in title posted. Maybe more to this?
We read these thoughtful, well worded replies and recognize the complexity and logic of the last couple of years. We are left with strong sometimes isolated facts pointing toward a proven concept/proposition CNS Homeostasis. Is it possible that the human body can treat itself w/help from A2-73? A lot of smart people argue here yet no evidence of any agreement on facts between the two camps. They do not want to agree in some cases. It all, this will come down to answering the question on CNS Homeostasis like an old Sci-Fi movie.
Until it can be said there is solid/validated evidence that an effective treatment for CNS diseases these debates will go one. IMO, the answer is known and the FDA will be the party to break the good news, soon.
Simple solution. Ask the patients (see interviews). Curious pattern however all other SOC patients cannot be interviewed.
bear is right...we are at the early stages of the battle of the century.
walker...agree w/3 and would add...
roy,
Thanks for a well informed, rational explanation of the process here. This is ALL ABOUT PROCESS. The rule book is being rewritten to deal with situations exactly like this one. All the best.
Same page see link on RTT. Interesting link.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2664709/
T-38 we will see ..
Now what? After decades of trial and error methods based on some clinical facts but otherwise flying blind what is next from the FDA and BP controllers?. Billions of $$$, thousands of hours in labs, clinics and lost patients. Worst of all the time that has been lost down rabbit holes to no where chasing plaque.
One can only imagine the level of utter frustration families feel while the lab rats keep their thumbs on possible treatments insisting that just b/c one small trial got miraculous results does not mean the prospect meets their brilliant scientific muster. AD always kills and yet they are in denial.
As a loyal investor here I am not comfortable just sitting by as the same gene pool that got us here holds up the process until they say "It's time to make the donuts". Do something.
Now, I feel a little better.
Thanks for posting this point falconer. The FDA is on the spot. They say they are preparing a new test scheme designed to help w/faster testing/results. Excellent. Their PR suggests game on in September? I would not want to be a clinic listening t that red tape stuff.
If the FDA really does have it's thumb in the dike then they better be right. My sense is AVXL and many others are in the queue and we ain't getting any younger over here.
Rey, of course everyone is guessing about the trials. However I think your scenario is closer to what will happen. No thinking should be based on how the FDA has done things in the past on times, size, structure.
Thoughts on the trade volume today? Daily Average typically>300, today 60 something so far? Has everyone left town?
Mike, I have thought along those lines. If A2-73 presents strong evidence based on simplified trials when BP/FDA after 20 years have proven that 96% of their product trials failed miserably then I would think someone has some splaining to do. Not only has the whole plaque thing been wrong but they kept beating it. A child can see it was a sad waste of people and money and most importantly , time. Regardless if A2-73 dominates or not it will have changed the game. It is also pretty clear the new FDA team has gotten the message, lets hope they move fast. Our clock is tickin over here. Clearly, the FDA has a lot of leadership opportunities, it better be ready to make up for lost time.
I looked at that and thought..."They stopped getting worse" (regressing, which of course always happens w/AD Pts) but how do we measure progress beyond t=0?. If most trials are set to measure regression(all AD)then holding their own is great but unexpected. In that context then MacF's comments are reasonable.
THX..."ICEBERG"
bear...as a follow up and supporting your ref.
I got the following from IR earlier in response to my concern about our recent down draft...point is the Jefferies conference talk looks like a key ref to AVXL as a position paper for now.
Saw this and wondered if evaluations of A2-73 had anything to do w/ potential shift. MS is huge revenue piece for them.
[[/quothttps://alzheimersnewstoday.com/2017/07/19/alzheimers-community-takes-hope-from-the-many-therapies-that-are-in-or-heading-for-trials/?utm_source=Alzheimer%27s+List&utm_campaign=a1715680c5-RSS_EMAIL_CAMPAIGN&utm_medium=email&utm_term=0_94425accb7-a1715680c5-72173229e]
35 treatments now awaiting AD p2 and 3 for P3...hey I know, lets change the trial structure since the current structure has not produced anything in over a decade.
It's times like these that bring out the vision of obvious corruption and criminal behavior of Wall street. This nothing to do with science, patients, news, results, plans. This is all about screwing the retailers.
Establishing context for the current science, finance, trials risk discussion...above all we have politics. FDA are risk averse, we know that. IMO, there has to be a better way than what is in place now. We need to understand that there is a lot more to this than a simple 10 person biotec company's ability to demonstrate new science. We are IN the tank w/the sharks who are not accustomed to being controlled and who do not "DO" help. If it were just about trial design approval then we got this. This whole thing is about risk.
This recent piece is helpful in establishing context.
We can only speculate why D. M. picked Rett so early on but now, in retrospect, maybe he planned for it to be the poster child for this new set of rules/policies. Tricky move. Also explains news gaps. If all true we have to wait for FDA to call it even if it sucks. In a way, definitions are similar to BTD.
If AVXL has been granted RMAT for Rett Syndrome trials then tis looks like a slam dunk, based on previous trial results. All he has to say is he has RMAT and game over.
September timing is a recurring theme, which is about 3 months after most of us were expecting. Recent PR by new FDA trials leader says he will have new trial rules public in September. I am thinking that is why everything has been pushed out. No point in staring/talking about a new trial using rules that are to be obsolete soon.
I agree w/your insight on small world we live in. We speculate about what is at stake w/new FDA trials rules/new S/W being put to use and concepts like Homeostasis being brought to the field.
IMO, new trials rules will not be pass/fail like the old days. I do not know what they will be but expect evolutionary results rather than binary only. There will likely be a more detailed prediction on what should happen with pts which may shift emphasis from a room full of experts decisions to decisions based on how patients feel, move, function, perform
In any case, the FDA is now in the hot seat. Any Biotec that gets too far out in front of the new rules will be roadkill, IMO. They are damned if they do/don't. The good news is, IMO we will not have to wait for years to get results b/c the new process is what matters. If establishing homeostasis in CNS disease patients is an effective treatment then the outcome is certain. Predicting Other symptoms that develop flowing CNS cellular stability will have to remain what we do not know we do not know for the time being. Process monitoring and controlling will be critical. Trust the process.
Me to, it really, really sucks. The fact that these criminals are able to run wild and manipulate sp is unacceptable. Between Washington and Wall Street that average American is in tough shape.
I do believe that AVXL has the goods and will deliver but a day like today makes one wonder if government and the WS liars know or care about citizens w/ AD, PD, MLS, ALS, Rett and the spectrum of CNS diseases. It's all about money. Unless action is taken to make biotec off limits to parasites they are a endangered species.
You do not get it, they will hit a walk-off.
There is a huge gap between what folks on this board think they know and what is really happening.
http://www.investors.com/news/technology/new-ms-drugs-threaten-biogen-novartis-dominance/?src=A00220&yptr=yahoo
An interesting article on MS. Describes what this patient has been through with today's "Science" in medicine-trial and error BP/FDA technique. Information like this points to just how badly changes are needed. MS just sucks along with other CNS diseases. Massive amounts of $$$ being made by BP. I know people w/PD and ALS, awful way to live.
Kind of obvious but worth noting anyways. New FDA protocols also presents an opportunity to demonstration/proof of A2-73 CNS Homeostasis in multiple indications. (see iceberg)
This PR could have been written at any time, but it was not, timing is everything. Many have questioned the 3 trial plan and CY 17'time left along with other comments based on the old way of FDA trials life. Previously, Very large n, with zillions of $$$ and years to understand interpret results. The FDA-trial rules have been redone and will never go back, A2-73 is the poster child for the new protocols. The delay tells us that Dr. M. was in the room when the new rules were written. Clearly the new FDA trial modes are the reason DR M has been silent. He wrote this PR now to tell holders he was still on plan/schedule in spite of new FDA protocol delays. A very subtle but powerful message.
IMO, his plan and the tactics are designed around pt well being and share holders interests. Anyone betting against him is screwed.
dado...agree w/your connecting the dots. Today's PR includes a few more clues to support your thought. No only does the PR mention the 3 trials about to start(just in case we forgot or thought maybe not), and in mentions interconnected thought. First time I ever saw that in print and a "tip of the iceberg" comment. CNS still Homeostasis presents an uncontradicted thesis. Additionally, we just hired another giant who is well informed and who could have walked away but did not. Semper fi...keep swinging doc.
Bater,goose, others ...thanks for inspiration and great thoughts around why we are holding. Sounds like most question why AVXL silence. Me too. I feel A2-73 is BTD level, maybe even bigger, what ever that might be. If it is that good, we will probably not have to wait for any official FDA (big daddy) declaration and I think Dr. M. sees that coming. Then what happens? One 30 second video of one little recovered Rett girl could rewrite the rules overnight. My theory is Dr. M. is not silent by choice. M. has been way out in front all along, If he said publically what he believes, the men in the white coats would throw a blanket over him. IMO, the new FDA timeline declaration is evidence AVXL must be in the room, at the table and throwing elbows w/BP who will fight any change that hurts them. No other explanation makes sense and it is good news for AVXL, as much as that buys us. As Bill Murray once said in caddy shack.."so we got that going for us."
I have been directly involved in delivering one breakthrough many years ago. That company's output skyrocketed and never looked back. As far as I know the people who were telling me it was impossible are still standing there w/their mouths open. They never recovered either.
IMO, an unintended consequence of A2-73 treatment when it is better defined will be a complete rethink of much of BP. Will big $$$ be lost there? Can you say crash? Probably. Will medical device sales/uses be impacted (MRI/X ray/imaging)? What about the whole care industry? We really have no idea where this will go but we can say with confidence that if A2-73...and follow up does start a ball rolling and the FDA new rules accelerate that thinking then we witnessed it all right here. Are these fantasies, not really as much as projections based on current realities. In fact I look forward to the time when BP and the people who are slowing the change initiatives(and there must be many) will be questioned about their current motives and methods. IMO, we are actually winning even if it does not always feel that way.
Jimmy, some day soon the trial practices of the last 40+ years will be used as examples of how far they have come and never again. Just like we judge those who <100 years ago thought that washing their hands prior to surgery was a waste of time or did not understand how/when to use antibiotics/sterilization/decontamination. Sad in a way but it is how we have learned till now.
The practice of running 100's of AD pts through trials where the side effects drove many to just give up and which at best only delayed eventual passing is being phased out, ASAP. Yet there are some who contrast and compare a new system to something that really never worked as not good enough, it just became the legacy practice...and must be right. This is the same gene pool who would now second guess A2-73 and not enough trial hours, pts, results when no molecule has EVER done what A2-73 has done. Get over it, you are toast.
Perhaps the most important fact is that there are no contradictions to Dr. M.'s thesis on Homeostasis in CNS diseases, yet there are numerous contradictions to the whole AD plaque thesis, it cannot be validated. IMO we are looking at smaller, faster trials which produce results based on precise science. That is code for you can be certain it will work before you start, just do the proper trial and it will work.
IMO, the breadcrumbs (from FDA and AVXL) lead to smaller trials with stronger evidence from P1/P2. Pre/clinical evidence used to assess certainty based on precision science with a deeper-precise understanding vs AD plaque assessment then backing into a rationale based on autopsies. IMO, A2-73 and Dr. M's assessment of why it works is the best game in town. Predictions for time to FDA release based on previous models are simply irrelevant, IMO. Put away the shotguns boys.
IMO, this FDA delay-time out period was inevitable (new lab capabilities/new S/W capabilities/old trials practice clearly unsuitable any longer & other). Then A2-73 comes along at exactly the right time providing an excellent example/opportunity to reset. There may be others also but nothing bigger than A2-73.
Is this an explanation for delays...right in front of us all along???
To continue to advance these opportunities, we’ll be announcing this September a comprehensive framework for the development and proper FDA oversight of regenerative medicine. This new policy effort will comprise a series of new guidance documents covering many aspects of the regulation of regenerative medicine products. It will be announced as part of our Innovation Initiative. It will delineate our policies for appropriate and efficient regulatory oversight of regenerative medicine products, in order to demonstrate their safety and effectiveness. It will also create an accessible framework that will enable providers to more easily collaborate on proving these principles for regenerative products that are advanced within local medical institutions. We want to help facilitate these scientific advances, which hold out tremendous potential for treating and even curing diseases. To achieve these goals, we need to make sure that we have a modern regulatory framework in place that can allow innovators to meet the statutory requirements for demonstrating safety and effectiveness. "
https://blogs.fda.gov/fdavoice/index.php/2017/07/how-fda-plans-to-help-consumers-capitalize-on-advances-in-science/
17"...The trials rules are being redone as we speak for studies with certain (TBD-IMO) prerequisites and criteria. We cannot predict the format/protocols and criteria that will be used, although we have some hints that timelines will probably change. IMO, the emphasis will shift from heavy on stats and n to heavy on science and understanding pass criteria. There will be fewer/maybe no pass/fail trials if they do it right but more learning from trials. How results are reported may be different...all IMO.
So, they need to delay starting...all IMO.
I choose door #2...sort of..
2) Dr. Missling did not submit new data to AAIC because of some sort of gag order, or partnership, or something else that prevented him from doing so. While this is possible, quiet periods do not usually last more than a quarter -- so I don't think this is the case
This post is way over the line, zero credibility.