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Biostockclub...Brilliant work. I said then and repeat, the executive management at BIIB that allowed that last PR is about money,only. Stuffing the dead Amyloid hypothesis down someone's throat would be appropriate at this point and we are likely to see it happen.
There is a big baseball rivalry in the NE U.S.. Fans of these two teams not only want to see their team win but they also want to see the other guys lose. That is the kind of victory we want.
IMO, if it were not for the precision medicine initiative, we would never witness what we are about to see. We are saying that the amyloid hypothesis will be disproven. Most of the BP has already resigned themselves to that. But, either their signature(MF) will be on the paper or...
it's complicated, but you get the idea.
XENA
Will 2-73 reduce nerve damage to the heart in Parkinson's patients?
The SP response was noted here at length by some of us. We saw immediately that the PR had low technical merit and that the SP bounce was not based on sustainable results. Nothing has happened to change any of that. Points to the scale of challenges faced by AVXL. There's an old expression that does come to mind on the original BIIB PR, "You can't shine SHAT".
biostockclub...Thanks for once again adding significant value here.
https://seekingalpha.com/article/4187666
The article linked by you and here points out how vulnerable stockholders/buyers are/were. Some of use here had an immediate GAG reflex when we read the original PR piece seeing that the hype was not technically justified then or now.
All the best. BTW, I am w/David on this match.
FROM PR 070318
About ANAVEX®2-73
ANAVEX®2-73 activates the Sigma-1 receptor (S1R) protein, which serves as a molecular chaperone and functional modulator involved in restoring homeostasis. S1R activation has demonstrated ability to reduce key pathophysiological signs of Alzheimer’s disease: beta amyloid, hyperphosphorylated tau, and increased inflammation. In a Phase 2a Alzheimer’s disease study, ANAVEX®2-73 has shown dose dependent improvement in exploratory endpoints of cognition (MMSE) and function (ADCS-ADL). Full genomic analysis of ANAVEX®2-73 Phase 2a Alzheimer’s disease patients was performed. The ANAVEX®2-73 Phase 2b/3 study design includes genomic precision medicine biomarkers identified in the ANAVEX®2-73 Phase 2a study.
http://www.neurotropebioscience.com/
Noted similarities homepage design for NTRP and AVXL. Looks like a good potential BIIB score also? Just saying, RETT, Fragile X?. Some of this stuff you can cut w/a knife, IMO.
Stay alert out there.
Read on, they are not exactly the same although I understand your point.
https://seekingalpha.com/instablog/6460311-unemon1/4985776-behind-neurotrope-clear-overwhelming-links-fraudsters
Would BIIB and NTRP have an understanding?
OK...thx...need/want to see some positive outcome here ASAP.
Tred...agree w/you comment-observation.
Dr.M. has been very directly sticking his finger in the eye of the back room guys. IMO, he understands full well what he is up against. AVXL have taken the time to get their story cleaned up for AAIC. We simply do not yet know the level of detail/complexity that he is ready to present.
IMO the presentation should include 2 main stories. One story is the science-technology linkages which (hopefully) relate to responders markers/definite trace information which is then reinforced w/visual (PET) and powerful statistical knock out blows. Pull no punches. Second story should include RWE/RWD, patients/videos/witnesses, possibly live interviews. Not snake oil stuff. Something that brings "Precision Medicine" to life.
At all costs avoid back room/black magic/stay tuned messages. This is the Precision Medicine Renaissance Moment. All the dots that matter are connected. The level of documented science presented must be consistent with the level of risk and the criticality of the moment.
I find her totally credible
Biogen knows their hand is weak
baltimorebullet wrote-
Perhaps Biogen will highlight their upcoming phase 3 trial(to appease their shareholders) AND announce something (big or little) with Anavex, and with Pfizer backing off, declare themselves the king of the CNS world.
If they were going to throw some serious money at a relatively unknown company, a "package show" might be the way to go.
So I guess the reason for scientific hold-up is always humans being humans
Jimmy...
[Again, the scientific strategy behind a2-37 is rock solid!/quote]
Thanks for this link/science background article written in Jan 2015. I am Not dealing w/science detail just topics. I can see the exact terminology being repeated in recent papers in 2o18. Cannot help but reflect on how much insight has existed on the base for AVXL product science and for how long it has been known. Makes one question why this path has not been more thoroughly studied by BP/FDA/others? They chose instead to keep repeating the Amyloid hypothesis which of course was a dry hole. This is not new.
This entire area strikes me as at least unusual where so many talented people had key insights but never went past the theory level. The establishment did one massive repeated failure after another? In retrospect will the solution to the CNS disease swamp be a replay of the Fleming anti biotic model? Are we going to succeed in spite of our established system of massive trials, expense and wasted time? It looks like the basic causal-linked knowledge has been there all along.
What will we learn form a discovery process standpoint? Is that why BIIB and maybe others are in denial? Are they afraid of the big collective AHHHAA moment we are hopefully about to experience? I guess we'll see soon enough.
Kkevin says…
NO ADVERSE SIDE EFFECTS ...EXCELLENT
It is interesting to me that one poster is up on the AAIC website for AVXL and the other one is to be released on the day of the conference
Because it might affect their profits.
IMO Anavex is about to throw a monkey wrench into the healthcare for profit scheme. It has gotten out of hand, time for a change.
Kevin...your suggestion is by far the best one we have ….NO ADVERSE SIDE EFFECTS ...EXCELLENT, must also include highest sleep quality. Agreed.
Cannot be taken lightly.
BR
Can you cut that in half and say five years?
Nice...and you get some green group credit good for a breath of fresh air.
falconer...like the way you think. BTW, no one knows what the answer is but at least we are beginning to think about the question. Thanks again.
I have the bar set so low on neurological diseases that, if low to no side effects,
Thanks Huntsman. Any thoughts/insight on when we will movement here? Need to see signs of life soon.
We'll see won't we. I predict we might learn that the internal politics and AAIC deference to BIIB are a big factor in positioning. The massive $$$ from BIIB PR when it timed in was a big eye opener as I would have previously thought such things do not happen. The most generous description I can give to the BIIB PR as written is sloppy. There is no way the FDA can seriously consider their results w/o adequate system validations. BIIB states in their own PR that they have not completed and analysis of results. Why was that dropped before they were done? No response required, we do not know.
IMO, these events happen in the sequence they do for a reason and not at random. We'll see. I also continue hope for the best here but am also watching b/c there is more at work than the science IMO.
jimbo
If potential super responders are relegated to the sugar group will they be denied access to 2-73 when the dosing arm(s) shows inprovement over the placebo
That would potentially be viewed as unethical and immoral. So it seems early approval is practically guaranteed.
Seems like a molecule that restores cell homeostasis, without side effects, could become very, very valuable.
Questions I ask as we approach AAIC.
1. Would Dr.M. pull in an AD trial and announce it before Rett trials if he did not have an AAIC slam dunk? (no-IMO).
2. Is it likely he will show a direct link w/Biomarker analysis to responders? (Yes-IMO)
3. Will Dr.M. do a presentation at AAIC that shows a clear link to markers w/PET results that support patient related responses? (Yes-IMO)
4. Is it likely he will present evidence (RWD,RWE) of previously confirmed AD patient recovery, like video, AD Chorus, other. (yes-IMO)
5. Is it likely the AVXL team will present further evidence from Academic and Healthcare sources which further validate efficacy claims? RWD, RWE. (Yes-IMO)
6. Is it likely the FDA-NIH will respond favorably to new AVXL CNS disease initiatives? RTT, other (Yes-IMO)
7. Do you expect strong WS/BP/Fake Media support-praise and appreciation for the AVXL AD results, which they have endeavored to achieve for decades and have failed miserably to do? (No-IMO)
8. If BIIB claims are not validated by FDA should they be directed to stand down until they do so? (yes-IMO)
9. Is this a David v. Goliath Grudge Match PR showdown between AVXL and BIIB? (yes-IMO)
Xena, sorry, I do not know. Am not able to check today but will look when possible. BR
So approval of Rett would grease the skids for Alzheimer's and Parkinson's apparently.
https://www.fda.gov/downloads/drugs/developmentapprovalprocess/smallbusinessassistance/ucm572939.pdf
just an example of many such docs from FDA on how to convert anecdotes into RWD-RWE which may then be submitted as evidence in drug files. We should be looking forward to many such examples in the future. I think the concept is great however it obviously wants to be carefully managed.
News reached Chinese media http://www.epochtimes.com/gb/18/7/6/n10540669.htm
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Reply from AAIC ref my question on presentation-abstract vetting process. Recall my question of how BIIB could make claims of efficacy when their own PR says they have not completed a review of their data yet.
translation: How can you claim treatment efficacy while you admit you have not done a complete review of the test data? Additionally, BIIB used a brand new technology/tool/system. Was any validation of the system done prior to completing test? etc.
Text of letter from AAIC rep...very nice letter, well and professionally done. IMO.
Thank you for contacting the Alzheimer's Association about our rapidly approaching Alzheimer's Association International Conference (AAIC), which will take place July 22-27 in Chicago.
An important purpose of AAIC is to provide researchers from around the world and at every stage of their careers an opportunity to share their latest research discoveries, discuss their findings with fellow researchers and network with their peers. It is through forums such as AAIC that researchers develop collaborations that are essential to advancing the field.
Well in advance of AAIC, presenters are asked to provide an abstract summarizing the research to be presented. Each of the more than 5,000 abstracts typically received for presentation at AAIC is read and scored by multiple reviewers. This score is a key factor in determining whether the abstract is accepted for presentation. It is not feasible for all presentations to be vetted in full prior to AAIC, nor is it standard for scientific meetings to require such vetting.
Individuals presenting at AAIC well know that the study methods, results and conclusions they share will be heard by some of the leading scientists in the field and in the world. It is up to these and other scientists in the Alzheimer's scientific community to determine the merits of the research presented.
Best regards,
Xena...this is new...not posted before and is RWE of finest kind, Excellent.
while a person who re-sat the driving exam successfully regained their licence
Are you saying that volume will start to come into the stock or peeks at information?
Please think about it...
Thanks and I will of course do whatever makes sense. Let's face it, there are an awful lot of really smart people posting here. That has got to mean something. We each have our own life stories about what works and what does not. Many notable posters like Investor, Bear, Xena, Falconer, T38, Benny, Flakes, Bios, Mycroft ...do not want to leave out many but you know who they are. this is one hell of a pick-up team. I think we all learn from each other and are for the most part focused on getting our investment right but also on trying to make a difference by doing things right.
Anyone of us could be directly impacted at any time by CNS issues, which in my mind should be sufficient motivation to get it right. I am now coming to the understanding that if A2-73 AD trials and others but mostly AD do not fly we are screwed. Intelligent people not only note WHAT is happening but also WHY. Why is really a lot more important to understand. Dr.M. is a WHY guy. Starting with his macro rationalization around Homeostasis and now digging into those patients who responded in (WHY) (what started as a safety trial) he has dug into WHY. Where I come from he has done the work normally done in deep think research centers but he did it with a small team of smart people and he did in one lifetime, brilliant. THAT JUST DOES NOT HAPPEN. One thinly staffed organization has conducted an analysis on it's own patients into the most critical areas of the most complex human diseases. You have to love that and he did at what is comparatively the SPEED OF LIGHT.
One of our very informed posters here recently posted a message that basically said...no matter what we do it will not matter and AVXL will have to wait till someone important buys us/says something. I am not trying to characterize them as being overly synical with this comment, in fact normally IMO he would be right. We would be a big YAWN at AAIC and after. That is just the way it is.
If Dr.M. is able to produce the goods we need (I am convinced he will) then a process of discovery and new science of CNS will evolve. I am not smart enough to know what could/will happen technically (see Falconer/T-38 and others). I do think that from a dynamic systems standpoint the world is now ready to move on to REAL SCIENCE away from mass trials and BS such as what BIIB just did.
I also reason that he chose the early AD trail start surprise because he now has the goods along w/a convincing set of linked science stories to tell. IMO, after he gets done all the guys w/all the money will be after little AVXL and he knows that. I pray the parasites are going to be nuked. I also think we will get some peeks at this interest before the conference. Lets face it, we earned it.
Thank you for making excellent analogies
We need the clinicians and Doctors to make honest observations about what is happening