KayakerBC, thanks for an excellent post. I read quite a bit of the link and find it fascinating although I have had a hectic day and not concentrating as well as I should be. I'll look again tomorrow.

At first blush I am somewhat amazed at what appears to be a huge amount of variability in the processes and approvals. Not being a scientist and not having experience with the FDA I can only judge from the research I see.

I think it was BDAZ that shed some light on the FDA and RVX and if I recall what struck me in terms of how I could think about it was that the FDA may require a paradigm shift with how they (the FDA) understand and think about epigenetics and BET inhibitors. I wish I could find that post so I won't comment further because I can't recall the specifics.

In my post about Valiant's Addyi I should have been more cautious. I sure did not mean to imply anything about conspiracy in terms of FDA approvals but I sure see why it was interpreted that way. My thinking was very simple...Addyi seems to be a drug with a poor safety profile (perhaps I misinterpreted that) and possibly a small market for what I thought was a relatively trivial problem and yet it got approved. Therefore, why?

So the analysis of the FDA approval processes gives me hope re rvx-208. Personally, my own feeling is I don't really care about the FDA because a successful EU trial will do the job.

So thanks for the perspective. I'll have to hone my critical thinking.

Cheers

Toinv