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Sts,Extending the PDUFA date due to major amendment

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MedResCollab   Wednesday, 07/10/19 05:23:28 PM
Re: sts66 post# 200931
Post # of 339267 
Sts,

Extending the PDUFA date due to major amendment caused by solicited (requested by FDA) additional data submission is very possible here, either very soon, or closer to currently planned PDUFA date. However, the fact that FDA’s goal is to convene AC meeting no later than 6-weeks before the planned PDUFA date for priority review apps doesn’t mean it is at all too late for FDA to inform Amarin there will be one. In fact, a very common time to tell the applicant there will be an AC meeting, and the scheduled date, occurs two weeks after mid-cycle review, or about July 12th for Amarin. Somewhat later or earlier is of course quite possible.

Why anyone would want to sit passively in a long position here is beyond us. Especially after this run up. All you are possibly missing by selling until early-mid September are negative catalysts. In fact, the only positions that make sense until then are short leveraged.

Regards,
-MRC

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