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Post# of 425669
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sharinky

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sharinky

Re: moonotaur post# 198933

Friday, 06/28/2019 12:01:05 PM

Friday, June 28, 2019 12:01:05 PM

Post# of 425669
It was/is today. Not sure of time.

"As a reminder, the sNDA that we filed with them was filed on late March, PDUFA date is September 28th, mid-cycle review is the 28th of this month, and while it is not without precedent for companies to be notified by FDA of an AdCom yea or nay before this, there is plenty of examples of companies being notified beyond this point in the review cycle, so Amarin continues to prepare for the potential AdCom."
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