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Re: sts66 post# 51717

Sunday, 06/14/2015 6:40:56 AM

Sunday, June 14, 2015 6:40:56 AM

Post# of 427872
I have the feeling that there was not a lot of oversight in the drafting of the FDA's response letter. "Left hand didn't know what right hand was doing" Like you, sts, when I saw the reference to the SPA, I was elated at the prospect of that little tidbit having been introduced by the FDA themselves and thought "Way to go, Woodcock... Open mouth, insert foot, chew vigorously". I really don't see a clear way for FDA to successfully defend themselves in this matter.

One of the lovely things about Amarin's suit is it's simplicity. A very simple, succinct Constitutional principle is being presented in a manner that looks to be pretty bullet-proof. There are numerous supporting precedents (The oft-cited Caronia being recent, very, very closely aligned example and having been set in the this same venue will, IMO, provide some pretty formidable muscle).

I can't say that I would mind seeing a couple more Amicus briefs land on the Judge's bench (and hit the news-wires). Amarin could never afford to buy this kind of publicity.




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