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Another one (CNS Disease pfizer) bites the dust.
https://finance.yahoo.com/m/4100621f-94f6-3abe-ba1a-b4f4b494c9e5/ss_pfizer-stops-developing.html
Any thoughts, clues, explanations on why AVXL sp continues to waffle-edge downward or what ever the technical term is for what we have seen since last trial start PR? I am open to rational conspiracy theories as explanation. SP seems to have no correlation with potential of product plans or healthcare system need. A2-73 is at least as viable AD option as BIIB's.
BTW, if it is due to some shadow competitor effect please provide evidence.
Just thinking out loud during this calm as I believe we are in the eye of a much larger storm around us.
Tred
Thanks Kevli33: Dr.G. says ...I have broken the code below.
We’re working closely with our public and private sector partners to better meet shared public health goals and address cross-cutting scientific and technical challenges, while making regulatory decisions more transparent and predictable for all stakeholders. My recent written testimony on how the FDA is implementing the 21st Century Cures Act contains an overarching picture of the agency’s many activities related to our new policies aimed at advancing innovative products.
I’d like to use this opportunity to reflect on how the FDA is creating a new operating system for innovation by modernizing clinical trials, streamlining the FDA’s organization and processes to advance regulatory science, and expanding the FDA’s capacity to analyze complex real-world data streams to detect early safety and efficacy signals. And to describe the new policies we plan to announce to advance these goals. These mutually reinforcing efforts will help the FDA meet its mission of promoting and protecting public health, and they will help unlock the full public health potential of America’s public and private investments in medical research.
Modernizing Clinical Trials for Drugs and Devices
Prospectively randomized, placebo controlled clinical trials are often the most powerful tool that we have for answering fundamental questions about the safety and efficacy of new medical products. But greater efficiency is needed, as clinical trials are becoming more costly and complex to administer. Moreover, many of the new products that we’re being asked to evaluate aren’t easily evaluated using these traditional approaches. At the same time, new technologies and sources of data and analysis make better approaches possible.
dia76ca
Dr. Macfarlane has said that he expects the trial enrollment will be "rapid". I trust his judgement!
OK, I'd go for a 50/50 merger. Our IP with Biogen's pocketbook.
Extreme said..
They will go on until the last possible moment or until they purchase a company with a promising drug that is in another direction.
Is it OK-rational to HATE a color? Red is a really lousy color.
Powerwalker, thanks for the link and information. I remain baffled by the BIIB AD product development efforts. The management seems to have a blind spot around the Amyloid thesis long history of failures. Yes, they have a lot of money to throw around so their campaign seemingly stretches over the horizon. I get the sense there is some kind of silent showdown w/AVXL being played out. Anyone who holds BIIB stock should be paying attention.
Is this reported BIIB "progress" from their PR 8/28/18 positive news or not positive news?
Of the 185 patients dosed with aducanumab in the Phase 1b study, 46 patients experienced amyloid imaging abnormalities (ARIA)-E (edema). Eight patients experienced more than one episode of ARIA-E. The majority of ARIA events occurred early in the course of treatment; they were typically mild radiographically (MRI), clinically asymptomatic and resolved or stabilized within 4-12 weeks, with most patients continuing treatment. In the Phase 1b LTE, the most commonly reported adverse events were headache, fall and ARIA.
Blessings upon your family with courage to all in staying the course.
Godspeed to AVXL
Steady T:
This is a good sized step forward.
Are we (AVXL) the only game in town? We here are typically cautious about even thinking this way much less saying it out loud. And of course we have our resident gloomers and risk predictors. So, we try to keep some rational low key context, it is what it is.
Curiously, A couple of weeks ago the BIIB boys were openly folding their cards. Example:https://forextv.com/market-news/theres-new-evidence-that-the-dominant-approach-to-alzheimers-may-be-completely-wrong/
If I were a big cash holder of stocks and wanted to make a pile more, and if I thought I could move the AVXL sp a little then I would. Once down as far as I could get it, I would jump in w/both feet. Then I would let the smoke clear a little, blow my BIIB holdings up and create something positively dramatic (TBD) about A2-73.
But, I'm not yet wealthy and would not own BIIB anyways. So now I am going to go buy a few more lottery tickets.
Interesting that once again we have the brave Aussies leading the way to attack Alzheimers...just as they lead the way at Tobruck and El Alamain!
God bless 'em!
No correlation - it's the algo du jour...
Riddle me this...?? Why is SP down after the first Precision Medicine trials for the largest WW CNS disease is announced? How can such a move down have any correlation to this PR?
https://finance.yahoo.com/news/first-patient-enrolled-anavex-life-110000178.html
BTW...BIIB down in pre market today following (AVXL&BIIB) PR's. Does this suggest that their latest Amyloid thesis try-all will go off as a gas?
Interesting timing on this SA article vis a vis our announcement of first patient enrolled.
The trial is not even updated on Australia or US clinical trial regustry which will give primary completion update
Support for five to seven clinical trial awards anticipated
We’re looking for applications to develop and implement Phase I to III clinical trials that would use the ACTC coordination and management infrastructure. We plan to fund promising pharmacological and non-pharmacological interventions that may prevent, delay, or treat the symptoms of Alzheimer's disease and related dementias.
I’ve been patient for several years now so I’m hanging on, but that’s just me.
Talon...here is new design link...look familiar?
https://www.newsweek.com/irans-new-fighter-jet-copy-us-plane-1960s-military-experts-say-1085804
T-38, thanks. I keep getting hung up on the difference between guiding and leading. I'll get over it. Curious if the latest Iranian AC design looked familiar to you. They just announced it a couple of days ago. BR
FDA isn't fond of the Quality Assurance of dosage controls by the manufacturing facility of the drug.
Thank you for information on IND process. I am familiar with it. Also, thanks for confirming that the FDA's method for establishing priorities is based on whoever walks in the door next.
It’s first come first served.
Curious. Does anyone know the basis for "who's Next" in the decision/processing queue at FDA? Is it public welfare? Is it total systemic cost? Is it politically based on who is in office at the time? Is it the number of patients/cost per patient/overall healthcare system costs?
Is there any score sheet anywhere that tells us when a priority will be set for AD trials for example? (not only AVXL) Maybe when we get an idea then the details being speculated here can be considered in some sensible context. Who is in charge?
I do see an opportunity for big impacts being managed in a rational and positive manner. No one here really has a clue on why these decisions by FDA are taken? We assume there must be some one in charge w/a plan. If that is true then we sure should be asking why FDA spent the last 20+ years using process methods that produced nothing of value for treatment of AD, and BTW where is the FDA plan for all other CNS priorities or do they just wait for someone to walk in the door w/an idea?
Sure would be nice to have a rational-fact based-status discussion, including any facts on process changes and relevant impacts. Just like these were serious issues.
Janet to Chris, 12/15/17 - "You'd better start those trials abroad. Alzheimer's treatment is too important and there is no way we (the FDA) are going to get our act together in time."
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Kentucky 123 says..
There are hundreds of Biotech companies with promising drugs on a variety of issues and all wanting the attention of the Bureaucrats, clerks or whoever. It is a nightmare.
More on connecting FDA dots.
https://www.fda.gov/medicaldevices/digitalhealth/
Some of us here have reviewed how the FDA MUST KNOW they have process issues. Of course all of that is to be expected during periods of significant technological evolution. We might argue such concerns are particularly notable in CNS disease-land where complexity/criticality and innovation are always up next...bottom of the 9th, w/bases loaded and two outs...seems to be the ongoing game plan scenario.
If one does a little checking(google searching) around. Guess what, you're right. The FDA is in a process kerfluffle and it is impacting what gets done and when and who does it and when will they get funded and all the systemic rest. Not to mention the political and BP human exponents in every CNS decision.
So the GOOD NEWS is, we are right, the BAD news is we are right. The use of other systems (countries) to conduct arguably the most important testing of the century (CNS Multiple indications) may not be pretty but it is an important and correct choice (IMO). With the belief that there will likely be multiple treatment refinements going forward we have little choice. If we wait around for the FDA to fix itself we will all be dead. Good move M., execute the plan.
Very, Very NICE work Tredeherpete. Hits all the buttons.
Google says that FOIA requests made to the FDA are provided as required but several exemptions shield them in specific cases. These might apply in this type of situation:
Happy to have an opportunity to finally agree w/you on something.
This truly is about the/a problem solving process. IMO, when all the bright highly skilled industry and FDA resources begin to explore solutions using new tools and methods they will rewrite the books. When alternatives are evaluated using AI tools and verified by suitable virtual/clinical methods the entire development process will be compressed.
I suppose it is obvious but I will say it anyways. IMO, the Precision medicine (ala AVXL methods) completely GUTS the established FDA/BP/Political swamp hypothesis method. The first successes of this new process represents the Functional Equivalent to storming the FDA strangle hold trial ramparts. We are on the point and it is going to be a tough struggle.
https://finance.yahoo.com/news/edited-transcript-avxl-earnings-conference-013428392.html
IMO, he describes a process for treatment of CNS diseases. He describes the gene identification links. IMO, this alternate problem solving process to that of proving an hypothesis (T/F) supported or not by requisite statistical rationalization. Considering the complexity and criticality and now available alternate problem solving models it is hard to see how BIIB will continue down it's Amyloid hypothesis path much longer.
On a brighter note, Dr.M. is describing a well defined path for problem solving which at some point obviates the need for massive, time consuming trial process alternatives. When this process approach has been more fully practiced for efficacy will other "untreatable" CNS diseases be studied in the same manner? Obviously, the answer is yes. Does this mean AVXL presents a value added SP double hit? We present both an effective AD treatment investment along with a solutions process for the analysis and treatment of other CNS diseases. IMO, that is what Precision Medicine offers. It's a process and it works.
tradeherpete, thanks for an excellent assessment of the situation we see at FDA-NIH. There simply is not alternative explanation for why the FDA and our Healthcare system has not produced what the country needs over recent decades, in spite of the taxpayer money and resources thrown at it. IMO, it is as simple as...They like it just the way it is and do not want to change a thing. If they wanted to change/improve, they would.
Kentucky says:
The media does not ask the questions because the bureaucrats will not answer or they are afraid of damaging their sources. Everything is FUBAR in Washington. Thank God for trials outside US.
Kentucky says:
AVXL needs to stay away from the US FDA at all costs.
Bourbon...Keep Calm, we got this.
The God Doctor does not have some magic formula that will allow "us", meaning him, to do these trials on the cheap or in a hurry. Bottom line, the trials, assuming they ever happen, will take many years and cost tens of millions of dollars.