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Hayward,That “most likely” range was based on the

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MedResCollab   Wednesday, 07/10/19 04:44:03 PM
Re: hayward post# 200911
Post # of 339267 
Hayward,

That “most likely” range was based on the likelihood they would receive communication from FDA in the day-74 letter regarding preliminary plans to hold AC meeting or not, plus some possibility they would be told later during the mid-cycle communication (held by CC within 14-days after mid-cycle review). It is standard practice to at least be told by FDA they are not currently planning an AC meeting in the day-74 letter if they are not planning on one. In this case, FDA did not communicate that they were or were not yet currently planning on holding an AC meeting in the day-74 letter. That became definitely known to us on June 25th as per the CEO’s public remarks. That shifted the most likely window to 14-days from mid cycle review only. That would be up to or somewhat after July 12th.

To sum it up, the day-74 letter is when you normally hear of preliminary plans to hold or not hold an AC meeting (can be sooner for priority review apps). Clearly FDA was still undecided by day 74, or perhaps contingent upon reviewing new data submitted by Amarin (solicited) that might be cause for an Extension Letter instead. That would give the review team more time to decide ultimately what to do by the planned mid-cycle review and subsequent communication. Lots of moving parts. The key for FDA is to maintain flexibility during their review. If they’re not sure of something they will dig deeper until they are sure enough to act/request/communicate.

So:

-PR from Amarin that an AdComm meeting is planned and the date, or that one is not currently being planned by FDA, will come this week or next. If not:

-They may have been sent an Extension Letter instead, and will have to report a 3-month push back to the PDUFA date, and possibly also mid-cycle review. News on AdComm could be sent with the Extension Letter, or FDA can wait until the now pushed back mid-cycle review to decide definitively.

Likely drop below $19 on AC meeting announcement, and probable drop below $17 on PDUFA extension announcement. Worse if both announced.

We outline these overhangs for AMRN here:

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=149837081

Good luck to you.

-MRC


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