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Re: Investor2014 post# 349493

Saturday, 02/05/2022 8:27:37 PM

Saturday, February 05, 2022 8:27:37 PM

Post# of 470905
Blarcamesine first in the UK? Or, Down Under?

The British government and authorities love to show off their Brexit independence...[by approving blarcamesine for Rett?].

Two things to consider. First, the real possibility that the UK steps right out and approves blarcamesine for Rett; as a demonstrated measure affirming Brexit (British exit from the European Union and its pan-European rules). The first approval for sales and therapeutic use of blarcamesine could occur in the UK.

Or, the Australian Therapeutic Goods Administration (TGA) could make a similar ruling. The clinical trial of blarcamesine against non-pediatric Rett syndrome patients was centered in Australia, was it not? It has been posted that the US Food and Drug Administration (FDA) actually was not the controlling, registration, or moderating agency for the study; it was the TGA. If so, blarcamesine may first get approved Down Under.

Are these possibilities, too, for either the Parkinson’s disease dementia (PDD) clinical study, or the big Alzheimer’s clinical trial?

The FDA is not the only drug approval agency in the world. A lot of blarcamesine clinical work has been done in Australia, under the TGA. Anavex’s targeted CNS diseases do not respect national borders; are extremely costly for health care systems globally. Why is the focal concern only with the FDA? Please explain.
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