Replies to post #202348 on Amarin Corp Plc (AMRN)

[relocatedmetsfan]

ggwpq - "The $6.4B question is did Amarin, whether on its own or at FDA's request, had submitted additional data since 3/28/2019"


Would not that request and/or action constitute material information that company management should have announced prior to or at the public offering?

[CalMustang]

The $6.4B question is did Amarin, whether on its own or at FDA's request, had submitted additional data since 3/28/2019, that constitute a major amendment to the sNDA. I hope not, otherwise 3-month PDUFA delay.

Amarin IR refused to answer this question:

Q1a:Has Amarin submitted any data to the FDA, either on your own initiative or at the FDA's behest, since the original 3/28/2019 sNDA filing?

A1a: As part of the normal sNDA submission process, Amarin does work with the FDA to provide necessary information.

I cannot comment on the specifics around the communication processes.



Q1b: I understand that communication is ongoing -- however, my questions pertains as to whether any formal addendum(s) to the sNDA submission have been formally transmitted... i.e. above and beyond normal communication that is inherent to the sNDA process.

A1b: We are not commenting on the FDA communication.