This meeting certainly has bearish consequences. Given the high level FDA'ers present and Amarin's slew of lawyers & execs, I would be willing to bet that FDA rejected NCE and Amarin demanded a meeting to discuss why or lobby harder for it. Tough to spin this positively
I've talked with some about Amarin's patents and they really didnt see them as a huge barrier. Some of Amarin's patents say no DHA, well what if an analytical chemist at Teva finds 0.01%? Also, there is a ton of prior art out there from Epadel for someone to challenge Amarin's patents.
Some head honcho from the FDA at AMRN meeting :
E Dickinson, Esq.; FDA Chief Counsel;
Jay Sitlani, FDA, Regulatory Counsel.
K Webber, FDA Dir of Pharma Sci;
D Esposito, FDA Deputy Director - Office of Regulatory Policy;
E Coleman, FDA Deputy Director, Metabolism Division;
C Rosenbraugh, FDA Director Office of Drug Evaluation II;
K Johnson, FDA, Regulatory Project Manager;
M Unlu, FDA Gen'l Attorney;
K Dettlebach, FDA, Gen'l Attorney;
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