You described the FDA's response very succinctly and accurately. Makes all that work by Dr. Ma and so many others a total waste of time when you get a response (a non response really) like this. Not to mention that it took over 16 months to get a response.
Really did not actually answer any of the points brought up by the CP. With that kind of response I wonder if Amarin is now on such a shit list with the FDA that they will never get a fair shake.
Think they need to convince big pharma of the potential success of V in Reduce-IT and have them take it over. Better luck with the FDA.
This is stonewalling at its finest. The agency requires a four tier appeals process? Talk about bureaucracy! The FDA needs to be taken apart. Like many federal agencies, it has become too big and created walls to insulate incompetence.