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Alias Born 10/07/2013

Re: None

Saturday, 10/19/2013 9:27:35 AM

Saturday, October 19, 2013 9:27:35 AM

Post# of 425940
As I view FDA request 3 things in ANCHOR:
1.) primary eps
2.) secondary eps
3.) ongoing R-IT
and the ANCHOR is not for reduce CVE, but reduce TG. Amarin met with all requirements, however FDA changed the point 3.) to compeleted R-IT. I do not say fine, but OK, However how? They have to follow some regulation, at least inform the sponsor in written format and not by the AdCom BD suggestion.

So, it could be one of the following:
1.) FDA did not follow own rules and regulations
2.) Amarin received the notification, but did not release it.

Amarin has to issue a PR to clarify the situation.
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