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Re: stu_har post# 230562

Wednesday, 11/27/2019 12:31:13 PM

Wednesday, November 27, 2019 12:31:13 PM

Post# of 425795

Atom, there is only one CP pending based on the FDA denial on one yesterday. The sNDA is still pending.



No, there are two,

If you require additional clarification, to put it metaphorically, using the remaining citizen petitions as a 'canary in a coal mine' (hyperlink) to warn of impending FDA approval for Amarin's sNDA may not be effective because historically FDA action and petition rejection occurred at the same time. But of the two petitions remaining, the petition submitted on 7/17/19 would be the most telling because it directly relates to the sNDA.

Pending petition submitted 7/17/19: https://www.regulations.gov/document?D=FDA-2019-P-3424-0001

Pending petition submitted 7/8/19: https://www.regulations.gov/document?D=FDA-2019-P-3266-0001



There used to be three,

https://www.regulations.gov/document?D=FDA-2019-P-3265-0001

but it was rejected yesterday.
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