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Re: jessellivermore post# 208320

Tuesday, 08/13/2019 12:03:09 AM

Tuesday, August 13, 2019 12:03:09 AM

Post# of 447919
JL -- your timing is off.

< July 30 2019: FOIA Requests filed
< July 31 2019: FOIA Request Rescinded
August 7 2019: FDA informs Amarin, off the record, that an Adcom is coming
~August ## 2019: AdCom scheduled for >11/13/2019? [note: realistically, w/ Veterans day on Nov 11, and Thanksgiving Nov 28, this may be December*).
~Sept ## 2019: PDUFA Date of 9/28/2019 gets pushed to Dec 2019 / Jan 2020??


*History:
In 2018, no adcoms between Nov 16 and Dec 4
In 2017, No adcoms between Nov 16 and Nov 30
In 2016, No Adcoms between Nov 18 and Dec 5

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