Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
That we must, but most projections are for over 9B by 2050
tradeherpete: Thanks for presenting a badly needed message on integrity gone missing. IMO, it all started w/political correctness and has continued at an accelerating pace. One must search and be aware of the large voids where "Reality"...WHAT IS REAL has gone missing. Medical research notwithstanding.
Call it a hunch or whatever. I believe in the science and I can't wait anymore.mauismart
is there really such a thing as a "decent buyout"?
e.g. AU conditional approval, partnership or BO) before we get a readout from PDD
until there is surprise news that draws public attention.
https://alzheimers.com.au/our-work/current-clinical-trials/
I have sent a note to the study staff identified in this link asking for more information about the sleep studies. If/when I get anything back will post here. Looks to me that they are separate study and may not be part of each AD/product trial.
how do you feel about the repeated pulling/modification of presentation titles?
I believe, even prior to Hampel, Anavex had a history of Submitting Presentation titles that end up being modified or pulled before the actual presentation takes place.
Anavex should include endpoints for retaking driving licenses, reading books and the playing of instruments
First...pinch yourself....then, read this...(from FDA paper on RWE-RWD)
/ Observational clinical studies might be another way to generate RWE that is relevant to effectiveness determinations. Therefore, the RWE Program will also consider the evaluation of observational clinical studies using RWD to support product effectiveness determinations.
Observational Studies. For purposes of this framework, observational studies are non-interventional clinical study designs that are not considered clinical trials. FDA considers a retrospective observational study to be one in which the study identifies the population and determines the exposure/treatment from historical data (i.e., data generated prior to the initiation of the study). The variables and outcomes of interest are determined at the time the study is designed. In a prospective observational study, the population of interest is identified at the start of the study, and exposure/treatment and outcome data are collected from that point forward. The start of the study is defined as the time at which the research protocol for the specific study question is initiated. Observational clinical studies might be another way to generate RWE that is relevant to effectiveness determinations. Therefore, the RWE Program will also consider the evaluation of observational clinical studies using RWD to support product effectiveness determinations.
XENA
I honestly don't think that the science is developed enough for the FDA to declare Alzheimer's biomarkers definitively yet... which could be why Anavex isn't doing a trial here
FDA guidance-information on RWE-RWD and the future of uses in trials, etal. Very, very nice stuff.
McM….
Would like to know what other biometrics are being tested..
Eyesight?
Should be in the test parameters..
georgesk-Great news, thanks:
To advance all of these goals, the FDA has other efforts underway. For example, the agency is funding a project to evaluate the potential of observational RWE to replicate the results of 30 clinical trials from several therapeutic areas. Being able to replicate the findings of trials is a cornerstone of the scientific method. This project should give us greater insight into which RWE methods and trial designs can provide insight into the opportunities and limitations of using these designs in regulatory decisions.
Strikes me as a risky process:
Biogen 221AD205 EVOLVE – Phase 2
A Phase 2 study assessing the safety impact of continuing dosing aducanumab in asymptomatic amyloid-related imaging abnormalities in participants with mild cognitive impairment due to Alzheimer’s disease or with mild Alzheimer’s disease.
Who can be involved:
Male or female, aged 50 – 85 years inclusive, at the time of informed consent
Must be diagnosed with mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s disease (Based on what? The FDA says this takes 2years to establish via cognitive methods testing)
Has an identified, reliable, study partner
If using medications to treat symptoms related to Alzheimer’s disease, doses must be stable for at least 3 months prior to screening
For further information please contact Paula Mather, Clinical Trial Coordinator on Ph: 08 9389 6433 or Email: aarfctd@alzheimers.com.au
What is involved:
Monthly visits
12 months duration
Monthly intravenous infusions
Talon...thanks for this link. Two observations from the trial flyer.
a. Possible 1x1 w/BIIB.
b. Sleep is being measured/evaluated for memory-thinking:
Sleep Study
This study aims to examine whether improved sleep (better or longer) contributes to better memory and thinking, and improved markers of brain health (assessed using brain imaging). The study will implement a non-pharmacological intervention to improve sleep in older adults who are ‘poor sleepers’.
Who can be involved:
Male and females aged 60 years and over who are ‘poor sleepers’ but otherwise well.
Residents from Western Australia
For further information about the Sleep Study please contact Manja Laws, Research Assistant on 08 6457 0264 or email m.laws.@ecu.edu.au
* Please note that participants in all studies may have a chance of being placed on a placebo medication
https://www.nih.gov/news-events/nih-research-matters/sleep-deprivation-increases-alzheimers-protein
As has been pointed out, sleep could be an important indicator for AVXL
Short-term memory not super great if it is a minor matter.
I should have been a doctor
investor:
Predicting Progression from Mild Cognitive Impairment to Alzheimer's Dementia Using Clinical, MRI, and Plasma Biomarkers via Probabilistic Pattern Classification
In principle sleep could be one biomarker and serve as a surrogate endpoint in a longitudinal P4 post approval study.
Thoughts on why AVXL todays pre market dive?
How about "restoration of cellular homeostasis"?
Has a nice ring to it.
Life Expectancy is going lower because of the high drug overdose and high suicide rate.
Talon38, thank you for being direct on this point. There is absolutely nothing here that cannot be fixed w/the right direction and urgency and motivation. Ms. Woodcock is probably a hero. I am not a bit surprised to learn again that it is all about money. As you indicate, some understand that the human needs are what have been treated as baggage/secondary at best. I bet if you asked the average American they would think the FDA and the drug industry were working day and night to develop more effective treatments. I do not know the answer w/o more facts but if we can figure this out here then certainly the responsible parties already know, or should know.
I will add that people w/regulatory responsibility for producing safe and effective medical devices and Pharma products need to get their shat in one pile. Stop hiding behind the organizational politics.
Talon:
Another analogy for we aviators, in that we as the brains of our machines can manipulate fuel, electricity, hydraulics and our crew component to deal with possible catastrophic events involving our aircraft.....the only difference is that our clinical trials usually last for minutes/hours and if they fail we are not given the chance to modify and try again!!
Those recommendations in the article explain why the doctors just keep piling on the meds without regard to long term effects.
falconer..
Should this drug prove efficacious and safe in long-term phase 3 studies (or, perhaps even now), it should gain regulatory marketing approval from FDA. But even with that, which Parkinson’s therapy would you wish for a close relative, one that requires periodic (or even just-once) brain surgery, or a daily pill that while taken provides continuing suppression of symptoms (the Anavex outcome)?
Hmm.. would gene therapy be necessary if normal sleep were restored and neurogenesis became a more natural process?
The dynamics of stress, leading to sleep losses, leading to stage 1 AD cycle start and the U.S. death curve you have shown are linked as a system(I claim). This is a self reinforcing model dynamic that seems intuitively obvious. In an airplane it is known as a "death spiral". In that example as the pilot pulls back on the stick to stop the spiral dive he actually tightens the spiral, which then accelerates the dive. The situational awareness of the pilot during this spiral is key (usually happens during low visibility w/no horizon), they always die unless the right action is taken. Anyways the stress to AD cycle dynamic analogy seems clear enough. We are however trained to "screw the stress get it done", Which is like pulling back on the stick.
https://www.sleep.org/articles/sleep-and-stress/
https://csdd.tufts.edu/csddnews/2018/7/12/press-release-julyaugust-2018-tufts-csdd-impact-report-just-released
More to follow. Basket trials may help w/cost and efficiency.
FDA s WOODCOCK: “ The clinical trial system is broken “
In this study design, 272 patients are randomized to drug and placebo, and at some point, placebo patients are crossed 273 over to active treatment. If patients in the trial who were initially on placebo and then assigned 274 to active treatment fail to catch up (after a reasonable period of time) to patients who received 275 active treatment for the entire duration of the trial, a persistent treatment effect on disease course 276 would have been shown.