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sokol...yup, it's soup OK. Thanks, there is a light at the end of this tunnel we have been living in for years. Some pieces are falling into place for stage 1 of a multistage/years evolution in treatment of CNS diseases. Could be wrong(overly optimistic) but mark this day. FRIGGEN AMAZING....wait till BIIB finds out.
Hypothetical on the possible uses of the Cognision AI system (see 510K and latest patent application). Keeping in mind that FDA has recent been quoted as saying they are uncertain that Stage 1-2 AD even exists(b/c they cannot measure it...AKA , NO WONDER we cannot treat it) ….WELLLLL are we (AVXL and Cognision) on the verge of some kind of a BTD AD treatment party? Just imagine the trial scenario where patients are dosed at varying levels over time to optimize their individual QOL/RWE/RWD treatment. All subject to suitable validations of course. Brilliant...TOGA_TOGA_TOGA.
Mapman, yes I recall. Dr.M. and associates may have begun to ask questions about CNS for which we previously had no way of knowing the answers to (hard stop). BUT, new AI tools which can possibly present responses to those question in the form of measurable clinical facts. As observed here by Investor2014 the fact that a (Cognision device)technology leader at the company is named in our recent patent application begins to suggest something as well. The fact that his AI based device has an FDA 510K, very, very cool. It is not vaporware.
The old saying of, "if you cannot measure it, you cannot manage it", comes to mind. Such is the case w/CNS diseases.
SCORE: see Cognision system w/AI and FDA 510K K141316
#issued...good information to have as we go forward here. This should indicate some evaluation of the overall system has been conducted and found to be safe and effective. We do not yet know if any validation of claims for medical device uses in AD clinical uses, but would guess that would be the very first thing Dr.M. would ask.(anyone know how to get copy of FDA product test investigation w/o FOIA?) More evaluation before the use of the system as biomarker source for AD. DO NOT KNOW THAT YET, BUT THE POSSIBILITY SUGGESTS ITSELF. Could be a very NICE piece of technology for our purposes. This might also splain a few things.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K141316
Keep digging everyone, there's a pony in here somewhere.
Device Classification Name
non-normalizing quantitative electroencephalograph software
510(k) Number
K141316
Device Name
COGNISION EEG/EP SYSTEM
Applicant
NEURONETRIX SOLUTIONS
816 CONGRESS AVENUE, SUITE 1400
austin, TX 78701
Applicant Contact
cheryl fisher
Correspondent
NEURONETRIX SOLUTIONS
816 CONGRESS AVENUE, SUITE 1400
austin, TX 78701
Correspondent Contact
cheryl fisher
Regulation Number
882.1400
Classification Product Code
OLT
Subsequent Product Codes
GWJ
OMC
Date Received
05/20/2014
Decision Date
02/13/2015
Decision
substantially equivalent (SESE)
Regulation Medical Specialty
Neurology
510k Review Panel
Neurology
summary
summary
Type
Traditional
Reviewed by Third Party
No
Combination Product
No
TOTALLY.
http://www.cognision.com/wp-content/uploads/2017/11/Clinical-Study-FDA-Approval.pdf...looking for FDA license of site and operations.
Would we recognize good news if we found it in our oatmeal? This looks like Aus has a new-effective method for clinical verification of stage 1-2 AD and (BTW) it is being used in an important A2-73 trial (possibly already done) and also(BTW) a new A2=73 patent application makes 10 claims on stability in cognition for AD patients. Now, that's a good day, IMO.
http://www.prnewswire.com/news-releases/neuronetrix-has-been-selected-by-anavex-life-sciences-corp-to-support-the-upcoming-phase-2a-clinical-trial-for-anavex-2-73-281898201.html
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=145684423 along w/specific recent posts by falconer on CNS cellular Homeostasis
brichnyc. My sincere apologies for some wording in my note. It was intended to be a simple qualifier (IF statement) and was not well done. I am with you in strong support of the AVXL effort.
After a very,very long time of trying to give the benefit of the doubt I have learned there are some things in life which present no possible learning benefit (+/-) and I ignore them. Move on, life is short.
Investor2014:
Noted ref. PDD trial comments during 12/18 concall xstript:
Talon38:
A Fleming moment?:
Hey falconer...I think you get it. We are due for human quality of life beak-through stories. Some may even expect political interests reflecting yugge budget paybacks based on BTD. Have a great new year, looking forward to a non passive set of events. Is it possible that science is real?
Doc328: First of all, thanks for posting this useful link.
Question: Do the dates listed trigger any thoughts w/you about the pace of progress or anything else that comes to mind. For example, do I read this as the start being April 2018?
Anything else?
TIA
Ignored
quote:Optimism. ... Research shows that on average, human beings are hardwired to be more optimistic than not. It's an admirable quality, one that can positively affect a person's mental and physical health. Optimism can also help reduce a person's stress and increase longevity.
Suck it up boys and girls, there are a lot of CNS disease patients who are counting on some help.
1. Semiconductor Device Failure Region
Below figure shows the time-dependent change in the semiconductor device failure rate. Discussions on failure rate change in time often classify the failure rate into three types of early, random and wear-out failure regions (the socalled “bathtub” curve). However, there is no clear definition for determining the boundary between these regions.
Figure 1: Time-Dependent Changes in Semiconductor Device Failure Rate
1.1 Early Failures
The failure rate in the early failure period is called the early failure rate (EFR), and exhibits a shape where the failure rate decreases over time. The vast majority of semiconductor device’s initial defects belong to those built into devices during wafer processing.
While most of these defects will be eliminated in the final sorting process, a certain percentage of devices with relatively insignificant defects may not have failed and may be shipped as passing products. These types of devices are inherently defective from the start and apt to fail when stress (voltage, temperature, etc) is applied for a relatively short period, and exhibit a high failure rate in a short time within the customer’s mounting process. However, these inherently defective devices fail and are eliminated over time, so the rate at which early failures occur decreases.
This property of semiconductor devices where the failure rate decreases over time can be used to perform screening known as “burn-in” where stress is applied for a short time in the stage before shipping to eliminate devices containing early defects. Products screened by burn-in not only improve the early failure rate in the market, but also make it possible to maintain high quality over a long period as long as these products do not enter the wearout failure region.
1.2 Random Failures
When devices containing early defects have been eliminated to a certain degree, the early failure rate becomes extremely small, and the failure rate exhibits a constant level over time. In this state, the failure distribution is close to an exponential distribution, and this is called the random failure period.
The device failure rate is normally at a level that can be ignored for the most part. Most of the failures are due to devices containing relatively insignificant early defects (dust or crystal defects) that fail after a long time or random failures such as the memory soft error by alpha particles and other highenergy radioactive rays.
1.3 Wear-out Failures
Wear-out failures are failures rooted in the durability of the materials comprising semiconductor devices and the transistors, metal lines, oxide films and other elements. In this region, the failure rate increases with time until ultimately all the devices fail or suffer characteristic defects.
The main wear-out failure mechanisms for semiconductor devices are as follows: 1) Time-dependent dielectric breakdown (TDDB) 2) Hot carrier-induced characteristics fluctuation 3) Electromigration
Semiconductor device life is defined as the time at which the cumulative failure rate for the wear-out failure mode reaches the prescribed value, and is often determined by the reliability of each element comprising the device during the process development stage. These evaluation results are incorporated into design rules in the form of allowable stress limits to suppress wear-out failures in the product stage and ensure long-term reliability.
An example of time/temp regression in semiconductor physics. Create similar model for CNS diseases so that we solve for time. TIA.
https://www.google.com/search?source=hp&ei=p_gcXO2YKIiyggfWwYH4Bw&q=semiconductor+physics+failure+time+temp+regression&btnK=Google+Search&oq=semiconductor+physics+failure+time+temp+regression&gs_l=psy-ab.3...3673.452829..456526...2.0..0.222.6801.0j48j2....2..0....1..gws-wiz.....0..0j0i131j0i22i30j33i22i29i30j0i8i13i30j33i160j33i299.4AoCOPHViw0