Replies to post #208356 on Amarin Corp Plc (AMRN)

[marzan]

CalMustang, so FDA took the Adcom route after Amarin withdrew the FOIA requests just to keep Amarin under their thumbs. But what made Amarin to withdraw FOIA requests? Something promised during the label negotiations. Then once withdrew, FDA came up with the Adcom whip just to keep Amarin under check, imo. Why the 9/28 PDUFA date hasn't been changed yet by FDA? Looks to me Conditional Approval by 9/28 is in the cards. Post Approval Adcom after Dec 5th to iron out Label Changes, imo.

[jessellivermore]

Cal...

I do not understand your post..What timing are you referring to?

":>) JL

[jessellivermore]

Cal....

OK..got it..You are correct...

":>) JL

[jessellivermore]

Cal....

Amarin may just have changed their mind about the wisdom of poking the bear...They might have known that FDA was going to require an AdCom at that time...Good chance FDA had made that decision by late July...

Does it make any sense FDA might be more concerned about five irate senators beating down their door than any perceived grudge against AMRN

All this is speculation....at least on my part...

":>) JL

[sts66]

Erm....Cal, your timing is off as well AFAIK - TTE posted a data file here two days ago that showed the FOIA requests were filed (or closed?) on July 18. Don't know where you got the rescindment date from unless it was in another letter you got from FDA when you filed your own FOIA request for duplicates. And in another post you showed a Gmail that indicates you (and presumably G&S) did receive two of the requested sets of documents although you didn't indicate which ones they were, so I'm not exactly clear about anything related to the FOIA requests.

July 30 2019: FOIA Requests filed can't be a typo where you meant June 30 because MRC didn't file the CPs until the first two weeks of July so AMRN had nothing to request in June.