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rosemountbomber

04/28/15 6:25 AM

#48299 RE: biowreck #48298

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.
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Ray

04/28/15 6:32 AM

#48300 RE: biowreck #48298

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.
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Biobillionair

04/28/15 7:00 AM

#48307 RE: biowreck #48298

Amarin should reopen the appeal...lose and give stakeholders Justice by litigating the process with Judge Randy Moss.


1) refusal to overturn decision to rescind anchor spa because the sponsor did not continue to act on the appeals process?

BB