Replies to post #196436 on Amarin Corp Plc (AMRN)

[relocatedmetsfan]

Sum:
- no AdCom
- FDA won't say anything about AdCom … will approve the sNDA on or before September 27 (later than August 1)

What is your rationale for saying that the approval will come after 1 August?

[Sam81]

HD

“Filing Issues Identified” letter to Amarin together with “Priority Review Determination” letter then the “Filing Issues Identified” letter was "due" by June 10. … It is fair to assume (as of today): FDA did not indicate in the “Filing Issues Identified” letter (if any) whether it plans to hold an advisory committee (AdCom) meeting to discuss this application.

Let's say it was received by Amarin on the 10th or 11th of June
Don't they have 4 business days to release material information to the market?

So to be double safe and double sure, we need to wait till closing of Friday's Market. In my opinion, if nothing is released by Amarin by Friday close or even give them few more days, before Monday's Market Open, than most probably it will be safe to say that No Adcom is on the agenda

Any thoughts about the above?

[veteranseabee]

HD,

Thank you for your clarification. Very much appreciated!