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Showing posts from August, 2019

Update on Amarin Corp (AMRN)

T oday Amarin Corp ( AMRN ) announced that it received notice from the U.S. Food and Drug Administration (FDA) that the FDA plans to hold an advisory committee meeting (AdCom), tentatively scheduled for November 14 , 2019, in connection with its review of the pending supplemental new drug application (sNDA) for expansion of  Vascepa . Surprisingly FDA did not send this AdCom which is usually done within 55 business days. In other words, it should have been done by mid-late July. However, today the CEO mentioned in the conference call that FDA advised not to disclose it immediately. That's strange! There could be many reasons.. Well, as I pinged to my WhatsApp group,  in the after hour AMRN stock was down 23.6%. As I promised, I have analyzed sharing my thoughts. At this time one can speculate many things, I am sharing some of my thoughts: Amarin submitted over a million page of documents to FDA for their review (yes, you heard it right - m for million!) It obvious...