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Re: None

Monday, 06/24/2019 2:24:04 PM

Monday, June 24, 2019 2:24:04 PM

Post# of 426338
Regarding Ad Com communications:
Today email to CDER Director:

Janet-
To my knowledge the FDA hasn’t communicated the need for an Advisory Committee prior to R-I sNDA. As you are aware R-I was designed as the 3rd succession under FDA SPA protocols. Due to the ANCHOR rescindment I have requested the FDA communicate in a timely fashion with Amarin regarding R-I sNDA, this included the need for an Ad Com.

Can the FDA R-I review team please clarify with Amarin whether it intends to hold an Ad Com by the end of business today?

The need for this communication is directly related to the way in which the FDA publicly implied ANCHOR SPA was going to be rescinded during the October 16th 2013 Ad Com.

Thank you for your consideration in this request.

Sincerely



Short reply (In a very timely fashion):

Noted. Janet Woodcock





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