Replies to post #167510 on Anavex Life Sciences Corp (AVXL)

[Bourbon_on_my_cornflakes]

"Why did the FDA continue/or allow the continuance of Amyloid Thesis based trials for decades, long after any child could see they were going nowhere?"

The FDA doesn't do the science, the pharma companies do, and they believed in it enough to spend big $$$ on it. I wouldn't want the FDA closing down ANY research, they aren't qualified to tell what will work and what will not work before it is tested.

[kevli33]

Dr Pauline Maki : https://crwg.uic.edu/crwg-home/crwg-staff/pauline-maki-phd/

Sex differences in the association between apolipoprotein E e4 allele and Alzheimer's disease markers.

https://www.ncbi.nlm.nih.gov/pubmed/30182053


HH

Sex differences in Alzheimer disease - the gateway to precision medicine.

https://www.ncbi.nlm.nih.gov/pubmed/29985474

[falconer66a]

No Alternative

Why did the FDA continue/or allow the continuance of Amyloid Thesis based trials for decades, long after any child could see they were going nowhere? (see 99.6% failure w/> 1000 attempts over 20+ years).

Why? No other option was available. First, the exact, root, underlying cause of Alzheimer’s was not known (nor even completely recognized by the medical community today). It was presumed to be incidentally idiopathic with age. Happened because people got old, and with that, brain function declines. In the case of Alzheimer’s, cerebral aging was simply rapid and severe.

What, then, to fix? Waste protein deposits, beta-amyloids and tau tangles could be microscopically detected. They provided detectible chemical targets for therapy. The presumption (probably accurate) was that if the waste protein accumulations could be either prevented or completely removed, brain functions would be restored or preserved.

Nice idea. But so far, after billions of dollars have been spent on any number of chemotherapeutic approaches, every one has failed. Simply, pulling off and digesting the waste protein accumulations concomitantly disrupts other normal brain chemistries. Side effects inevitably too great; therapeutic outcomes too meek. The realization of failure with the waste accumulation therapeutic target is finally in place.

Frankly, the FDA had to let the waste protein approaches go forward. There was nothing else but the existing acetylcholinesterase inhibitors to treat Alzheimer’s. Sadly, those drugs only slow, for a period, the otherwise lethal progression of the disease.

Because it goes against what physicians and researchers learned from their vaunted med-school professors, researchers yet are slow to embrace the Anavex explanation of Alzheimer’s disease; or it’s unique therapy for such, with the proprietary sigma-1 receptor agonists.

All of that will change rather dramatically when positive results appear in the upcoming Anavex 2-73 trial in Australia. Last-century perspectives on Alzheimer’s causes and treatments will necessarily be discarded.

[xodcode]

HH also mentions Bill Gates' relatively recent interest and support for new AZ initiatives. (Wonder if Gates is a prospective source of capital for AVXL)

[Steady_T]

Why did the FDA continue/or allow the continuance of Amyloid

You quote is based on a fundamental misunderstanding of what the FDA does.

The FDA does not direct the course of drug research. It does not have the responsibility of determining whether it makes since to continue to pursue a particular line of drug development.

Those choices are made by researchers.

The FDA is responsible for evaluating the design of the trial brought to them by industry in terms of safety and design reliability.

If a drug shows efficacy and an acceptable level of risk compared to the drugs on the market then it is approved.

The FDA does not make decision about how drug researchers choose to allocate their money.