Saturday, May 25, 2019 5:11:17 PM
Together with the SAB and staff Dr. M. has undertaken a strategic trial path that is based on Precision Medicine. The Old school, "shot in the dark" trials proved nothing of value and will not be followed from here on. We all get the regulatory agency trial requirements concept w/associated proofs. Sadly, these historical trial paths till now (in the case of CNS diseases at least) have failed completely to achieve anything close to an effective treatment. The SOC is a medical joke and is recognized as such.
I prefer trials based on clinical proof followed by human trials of suitable size. I do expect that eventually the whole placebo string will be dropped. Looking forward to trials which are based on verification of correct science from clinical trials and sound patient analysis of recovery w/o AE's of consequence. There is an old technical quality concept called the bath tub curve. Over a short time, early failures are weeded out/eliminated early on (see Biomarkers as example), followed then by an extended period of many years useful life follows w/no failures, this is then followed by the wearout phase where we all die from various unrelated causes. Until now, no CNS disease trial has EVER got passed the early into the WEAROUT phase for ay more that a few months. In other words nothing has ever shown sustained efficacy for AD. Same thing for PD/MS/MD/RSD/etc. The existing trial methods show zero practical effectiveness. Just ask the patients and their families.
We will all figure this out eventually, soon I hope. The old FDA trial and error methods represent a troubling period to my understanding. I am just glad they are not making airplanes. I do not yet understand why they continued as long as they did, either corruption or incompetence.
Recent AVXL News
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