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boi568

12/18/20 9:03 AM

#288746 RE: dadbrotheroftwins #288718

I really, really like your creative suggestion to see if it is possible to seek FDA approval for GABA and glutamate normalization. Whether or not this requires the FDA to act outside the box, it can provide a quickly demonstrable path for 2-73 across multiple indications. GABA and glutamate are unlikely to be the whole ball game for Sigma 1 receptor related diseases, or even all diseases that can benefit from 2-73, but so what? We can start with Rett and Parkinson's and go on from there. Later we can apply on the current schedule for Alzheimer's.

It may take a while for medicine to catch up to this approach but it will allow quick results where applied. I just don't know how FDA regulations and guidances interact with your idea.

Hope Anavex sees your post.

baltimorebullet

12/18/20 9:11 AM

#288748 RE: dadbrotheroftwins #288718

Intriguing.

falconer66a

12/18/20 9:31 AM

#288761 RE: dadbrotheroftwins #288718

Would be the very best.

....ask for FDA approval for GABA and glutamate normalization, rather than a specific indication.

Indeed, eventually this should be petitioned from the FDA, which should approve this particular (albeit general) therapeutic designation.

Blarcamesine's optimization of gamma-aminobutyric acid (GABA) levels (increasing them), along with it's suppression of glutamate has been demonstrated in both murines (lab rodents) and humans, irrespective of any innate central nervous system (CNS) disease. Depressed GABA levels and elevated glutamate levels, in every case where they occur (in many CNS and other diseases) are pathogenic.

So, yes, it would be wonderful if the FDA would approve blarcamesine for any and all indications benefitting from increased GABA and reduced glutamate. This would work for both ALS (amyotrophic lateral sclerosis) and my rare HSP (hereditary spastic paraplegia), and a good number of other indications. With these, blarcamesine could be a complimentary treatment adjunct to other more disease-specific therapies in each case.

Blarcamesine also facilitates normalized, healthful sleep, particularly in CNS diseases with sleep disruptions. It should also be allowed for use as a soporific, sleep-inducing therapy.

Would anyone benefit from any of these new uses for the drug? Tens (well, hundreds) of millions. Safely.

powerwalker

12/18/20 10:01 AM

#288770 RE: dadbrotheroftwins #288718

twins, you should forward suggestion to Dr. Fadiran @ HQ ... or call him!

Great suggestion, BTW


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