Amarin Corp Plc (AMRN)

[HDGabor]

I think we have to wait. As I see:

AdCom was totaly useless (w this question) and not relevant, since
- AdCom vote is not bidding for FDA
- they voted about the sciense and not about Vascepa (to be honest this question - w BD - will be answered as no regarding any TG reducing drug)

My scenario:

1.) FDA will approve ANCHOR indication (maybe w some label restriction) on PDUFA date

2.) Prior PDUFA date "the director of the review division determines that a substantial scientific issue essential to determining the safety or efficacy of the drug has been identified after the testing has begun (section 505(b)(4)(C) of the Act). If the director of the review division makes such a determination, (1) the determination should be documented in writing for the administrative record and should be provided to the sponsor, and (2) the sponsor should be given an opportunity for a meeting at which the review division director will discuss the scientific issue involved (section 505(b)(4)(D) of the Act). This meeting will be a Type A meeting under the PDUFA goals for meeting management."

2.a.) FDA will approve ANCHOR indication (maybe w some label restriction) on PDUFA date
2.b.) FDA wil not approve ANCHOR

3.) Delay the PDUFA and "the director of the ..."

3.a.) FDA will approve ANCHOR indication (maybe w some label restriction) on PDUFA date
3.b.) FDA wil not approve ANCHOR

1.) 30%
2.a.)40%
2.b.) 5%
3.a.) 20%
3.b.) 5%