News 
Market Data 
Discover
Replies to post #214909 on Amarin Corp Plc (AMRN)
Is the PDUFA extension notice or the ADCOM notice between the FDA and Amarin FOIA-able? Or would it be considered confidential at this point and redacted to high heavens? Anyone with expertise here?
Seems to me it will be fully available at some point...if there was additional information (ie reason for delay, reason for ADCOM) in those notices I’d assume Amarin would want to disclose them so as to avoid potential repercussions later (if even applicable).
I’d be very surprised if something nefarious was taking place here...but I’m also surprised Amarin wouldn’t just post the actual communications they received from the FDA to provide investors with clarity and to avoid all the speculation.
As expected, later that day, Amarin Corporation, plc received notice from the FDA that the Prescription Drug User Fee Act (PDUFA) goal date in connection with the FDA’s review of the REDUCE-IT sNDA has been extended to the date previously announced as expected, December 28, 2019. The originally assigned PDUFA date was September 28, 2019. This typical three-month extension offsets three of the four months that would have been gained from the FDA’s earlier determination to conduct a priority review of the REDUCE-IT sNDA and accommodates the time period for the EMDAC meeting. Standard 10-month review of the REDUCE-IT sNDA would have resulted in a PDUFA goal date in late January 2020.
09/18/19 11:16 AM
09/18/19 11:24 AM
Seems to me it will be fully available at some point...if there was additional information (ie reason for delay, reason for ADCOM) in those notices I’d assume Amarin would want to disclose them so as to avoid potential repercussions later (if even applicable).
I’d be very surprised if something nefarious was taking place here...but I’m also surprised Amarin wouldn’t just post the actual communications they received from the FDA to provide investors with clarity and to avoid all the speculation.
AI
