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Wink, Wink. Nudge, Nudge.
The guy has been straight with us all along. Even on the worst days his story has been consistent. All the best to longs.
Falconer. Agree largely w/your message. News voids/vacuums cannot be respun/twisted/etc. Appreciate it if you would continue to scan the horizon for any credible CNS Homeostasis technical papers/other which contradict Dr. M.'s thesis, or any that reinforce the AVXL story.
powerwalker, thanks for your post.
The facts, dates, events which you refer to are a good sample of the behind the scenes work/information being boiled. There is obviously more we know about and probably a lot more we do not know about, all of which raises the bar on the importance of every little informed peep that escapes.
Those of us who are VERY close to every word are in wonder of the privacy/security being applied. We know we don't know a lot of things on trials, patent release PR date, Biib conference details, extended trial results, impact of new FDA trial regs and so on as you have identified so well.
NO LEAKS, not even an informed whisper, that's impressive considering what is at stake here. Makes one wonder about the things we do not know, we do not know b/c of the gaps above. I am inclined to believe that if this whole thing were vapor we would know or have leaks/clues/contradictions, considering the number of informed people here analyzing every peep/gesture/expression. This is reality, retailers and self declared experts are equally clueless.
https://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/scienceboardtothefoodanddrugadministration/ucm556618.pdf
see sec3051 FDA estimate up 20% growth in BTD b/c of legislation.
Although many others will be candidates, we should have a good shot at rapid processing. It has been a puzzle to me how Dr. M. could be so certain of 3 trials in CY 2017 while he must have known the FDA holdup was expected due to new rules (September?). Hate to speculate wildly but maybe they are telling us the pieces to this puzzle are in place? After the crap we have been through lately it is good to have a positive thought at least.
Does anyone know or be willing to give and educated guess on what date the new FDA rules will take effect? TIA.
Well Done..thx
IMO, some trials PR is seriously needed but cannot happen until FDA discloses new guidance developments. We have been caught in a box along with others, IMO. Agree it is a serious/exhausting test. IMO, when new PR describes trials/rules then we may get insights into results till now. I'm guessing but believe the trial plans have to be put into some context (protocol/rationale) to make sense, then we will have facts. I could be wrong, it may be kept from public view.
Yep, looks to me like a little bush shaking going on.
Cullen, Is it possible we are seeing push/scare action prior to possible news from Dr. Mac F on Weds from Australia? Hope for pop in A.M. if not by EOD today.
Just a thought
Is RGIN static b/c we await new FDA guidelines for trials? New trial rules, technical, other will slow things up. Just a thought, held up like everyone else till sometime in Sept.
Is this why BP are either in denial or throwing up in their Cheerios right now? see Anavex pr April 3, 2017.
Is this any kind of indicator for when the FDA releases new trial guidance? Curious, a possibility. The sooner the better.
I understood him to say that a broader set of combined trial data could be used to validate the hypothesis of CNS homeostasis as the fundamental root cause of (3 for now) identified CNS diseases. This is simply my read of his message. If proven true then of course the term breakthrough is entirely appropriate and I will probably retire .
T., nailed it.
Jimmy, agreed...there is a risk of getting off in the weeds w/interpretation but it is low risk to say ...and they know EXACTLY what they are looking for. Yes, of course there is learning still going on but this ain't your father's Oldsmobile any more. Maybe not to late to save FDA which explains their motivation. It's a win-win.
blue. I completely agree with your message.
Timing of both events being same day could be a couple of random events just happened to line up. Hey, It could happen. Considering how cautious AVXL is with news, it seems less likely but not out of the question.
And, considering we read how the new FDA trials protocols will emphasize patients responses and quality of their lives in a flexible format, then another opportunity may have presented itself. Giving Mac F. a chance to take the point gives him and the Aussie's govt. a moment of deserved recognition for their leadership. But again, just coincidences.
And, the use of the term "Breakthrough" in the title for his talk could just be an unfortunate editorial oversight. It is likely NOT, a message to LOOK HERE by application of the most explosive term in the FDA trials dictionary.
Fun to speculate, unless you are short.
Thanks for link. I expect Mac F will not be open loop from Dr. M. and any key message. In fact maybe some kind of PR will guide him. That said, Mac F is not a big proponent of test data details in his previous talks. He spends time talking about how pts. feel/act/smile/reason. How has the quality of their life sustained or not? IMO, he will not free lance. It is curious though that the title of his talk includes "Breakthrough". All the best.
Little DD shows outline of talk. Sounds similar to previous talks by him. If lunch time in Melbourne then time in NYC?
Agree, sounds right...or the whole thing could be more high level dribble. If they wait so long to say ANYTHING you would think it would be PR'd.
Thx Mikesc...That just happens to be the day Mac F is doing his presentation in Australia ...when the "B" word is used in title..huh
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.