Anavex Life Sciences Corp (AVXL)

[falconer66a]

“...why have no others been approved to treat CNS, or few other diseases?”

Simple. Getting a new class of drugs to market is extremely difficult. Takes years, with multiple big clinical tests, in multiple stages. FDA approval rules are extremely complex and exhaustive.

And, there are intellectual property rights concerns. Who’s going to spend several years of ones lab life experimenting with a molecule protectively owned by a commercial entity? Doesn’t happen.

Things got this way, pretty much, because of the thalidomide difficulty. Thalidomide was marketed, over the counter, in Germany in the 1950s. Wonderful stuff. Suppressed all sorts of psychological problems. But because it had never been tested for teratogenicity, disruption of fetal development, thousands of European babies died or were born without limbs. Be assured, FDA requires teratogenicity tests of all drugs (tested on animals, which have the same fetal development mechanisms as humans).

Fortunately, at the time, there was an FDA official, Frances Oldham Kelsey, who did not rely on information from the company. She single-handedly prevented thalidomide use in the US, even though FDA regulations were not as strict then.

Everyone is free to conduct thought experiments. Ideas cannot be patented or protected. But the testing and use of patented molecules is legally protected and restricted.