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Re: None

Wednesday, 06/03/2015 6:25:49 PM

Wednesday, June 03, 2015 6:25:49 PM

Post# of 425931
FDA is mindful that Amarin is seeking a quick resolution in this manner, and, to that end, is planning to issue the regulatory letter to plaintiffs providing the agency’s views as to the proposed communications about Vascepa discussed in the complaint to narrow the scope of the dispute by June 5, 2015.

Although Amarin disagrees with FDA’s ruling denying an indication for Vascepa in treating patients with persistently high triglycerides (ANCHOR), this case does not challenge that ruling.

Based on this info (facts) I think the letter won't be:
- full ANCHOR / granted indication
- change of label / inc. ANCHOR eff. data
(Please note: these do not narrow the scope of the dispute, any of them ends the dispute)

I expect something like: FDA won't count the proposed communication as a breach of regulation(s) or any Act, if it will be communicated as ...

The question: what will be the "as..."?

If it won't be a hard restriction: we will know by Friday (I guess Amarin will release a PR in this case) or on Monday as the latest, since the Court directs the Government to file on ECF the FDA's regulatory letter by June 8, 2015.
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