1. There is some belief of reform and new insight with the FDA already for 2/3 years. I dont see any sign of it. 2. The powers that be doe not permit it 3. A new kid on the block doing things differently like Anavex needs to provide solid proof.
IMO, you are not wrong in fact these observations have been made by others here, including me. The FDA presents a confused and conflicted image on CNS disease policies. IMO, there is something fundamentally wrong w/FDA's current scope, structure and charter. It needs to be changed from the top down. Also, support-ancillary system structures, like NIH, must similarly be taken apart and redone from the top down.
Anavex will provide strong clinical objective evidence of efficacy in treating CNS diseases or patients will not recover. If patients do not recover then Anavex will fail as an investment. But, there must be sufficient knowledge, skill and confidence in the judging bodies(private-public) to rationally and objectively assess the test results. I do expect the established BP interests to attack every aspect of Anavex accomplishments. They have overwhelming resources in the media and strong political bonds everywhere, FUD exists all over the world. Turns out, when patients start to live restored lives they will be heard.
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