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Re: alternatepatel post# 29667

Monday, 06/23/2014 8:27:04 AM

Monday, June 23, 2014 8:27:04 AM

Post# of 426504
End of July / early August for final decision of OND, but

'Amarin was informed in late April 2014' (10-Q) - so let say April 30
Amarin has 30 days to fill appeal - May 30 as the latest
FDA has to reply within 30 calendar days from the receipt of the formal request - it' June 29:
a.) complete the review
b.) unable to complete the review and respond within 30 days, the Official should notify the sponsor, explain the reasons for the delay, and discuss the time frame for completing the review
c.) Where additional data or input from others are needed to reach a decision on the appeal, the 30 day response should be a description of the plan for obtaining the information (e.g., requesting further information from the sponsor, deciding to schedule a meeting with the sponsor, bringing the issue for discussion at an advisory committee).

My guess: "deciding to schedule a meeting with the sponsor"
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