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Re: HDGabor post# 198020

Friday, 06/21/2019 7:35:37 PM

Friday, June 21, 2019 7:35:37 PM

Post# of 425648
HDGabor,

Where is this quote from? If it is a genuine quote from a C-suite executive, and not simply IR, then it most likely means it has not been confirmed for certain, which confirmation will not come until after the FDA holds its internal mid-cycle review, where this final determination is made and soon thereafter relayed to the applicant. In our view, final and certain notification of an AC meeting is still very much in play, and even on track. June 26 - July 10 is what we see as the most likely time frame in which a final determination and set date for AC meeting will be relayed to the sponsor, though it could come somewhat sooner or somewhat later. If no word beyond July 20 it becomes far less likely.

We are of the opinion that the FDA has at least conveyed to Amarin via the day-74 letter whether or not there are preliminary plans to hold an AC meeting, and if what you quoted is truly from an insider who is privy to all private conversations between Amarin and FDA, then it may be clever but misleading wording that in the future can come back to haunt them via class action suit.

Regards

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