I don't really think most companies reveal even a small fraction of the meetings they have with the regulators, so I have no idea who they have, and haven't spoken with. I really don't know if the FDA is the best regulator to begin with on RETT's, in AD they clearly chose Europe because much of the trials were done there. I know the FDA is considered the gold standard, but they're also thought to be in the pocket of the BP's. I don't know that approval elsewhere wouldn't be smarter. As an American I've never liked the way the FDA operated, they have delayed numerous products that were clearly worthy of approval, and every such product that I considered worthy was eventually approved as long as they could afford to go the additional mile demanded by the FDA. Sadly I believe millions of patients lose the benefits they could have received if the FDA had approved, and perhaps removed any doubts with a conformational trial. I think they've gotten a little better, but still aren't the dynamic agency I think they should be.
Gary
News 
Market Data 
Discover 
