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Thursday, March 21, 2019 1:46:16 AM
But, many have still not figured out that the FDA has shat the CNS disease bed.
I have to take issue with this statement. The FDA doesn't direct research. They tell the companies how they need to go about proving the research that Pharma wants to turn into a marketable drug.
Pharma decides what avenues for research it wants to pursue. The FDA doesn't tell them what to pursue. The whole plaque research program was undertaken because, at the time, the understanding of AD was limited and plaque was the most obvious target to go after. The tools available for diagnosing AD and for measuring AD severity were very limited. And for that matter are still pretty limited. There has been progress made in diagnostic tools and in measuring tools. The recent FDA guidelines make it quite clear that the tools are still inadequate. This has only been made clear because of the recent series of AD trial failures.
The number of failed trials had little to do with the FDA. The failures were because of a lack of understanding of Alzheimer's disease by the entire medical establishment. That lack of understanding is not anybodies fault, it is a reflection of the state of research into AD causes and pathology.
Anavex is pursuing a different direction in the understanding and treatment of AD and other CNS diseases. If and when 2-73 is shown to have the positive effects we all expect, it will be a major step forward in the understanding of AD and CNS diseases in general. Till then the understanding of AD is in limbo. It is no body's fault.
If investing was easy, everyone would be rich by now.
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