Interesting post. A two tubs of popcorn post.
You give the FDA too much credit and not enough credit.
The FDA is a reactive agency. They can only react to what is brought before them. I assume that in "guidance" meetings they can exert influence in some small degree but in terms of attempting to direct the general direction of research they don't have a lot of influence. Look at how long the pursuit of Beta Amyloid plaque has been going on.
Sure the FDA would like approve a drug that treats AD. The problem is that none have been presented to the FDA that show much signs of being a useful drug. The FDA is in the unenviable position of being the recipient of a lot of pressure and still having responsibility for the efficacy of whatever they approve. Remember the SOC is pitifully low. That is because there are no other choices available to the FDA.
The FDA is all too aware of the fact that many drugs in the pipeline never make it to NDA. That applies to Cassava and Anavex also. We who are invested in 2-73 think that it will make it to NDA. However the FDA doesn't consider promising, it considers placebo controlled trial results.
Until Anavex is in a position to provide the level of trial results that the FDA requires all the FDA can do is provide guidance on the existing trial data and suggest a path forward that will get Anavex to an NDA.
I'm sure the FDA will be having internal celebrations when a drug like 2-73 or the Cassava drug is approved and there is actually some hope for AD patients and their family. After all, approving a drug that works and gives people hope reflects well on the FDA and bureaucracies like good publicity, not to mention the good people that work there that want to see their work make a positive impact on people's lives.
The American Republic will endure until the day Congress discovers that it can bribe the public with its own money.
