Replies to post #200959 on Amarin Corp Plc (AMRN)

[HDGabor]

M-

(i) You do not have to repeat your view re. AdCom, it was noted.

(ii) Looks like you missed it: mid-cycle review meeting WAS on 6/28 … the FDA could not "held off on the mid-cycle review altogether" … since it is history now.

(iii) You misunderstanding me re. MO "issue":
a.) it is not a new "issue" … if they would like to hold an AdCom due to atypical lipid changes [ALC] they do not have to wait for the current review … they have enough info to announce it (by any letter by any date YTD)
b.) it isn't a MO "issue" … it was about ALC
c.) meanwhile you continuously narrow down the possible reason of ALC to MO it was one possible reason (among others) only
d.) MARINE was approved despite ALC
e.) ANCHOR had ALC also
f.) FDA did not conclude in any of these that the reason is the MO
g.) Amarin and FDA reviewed / resigned the SPA in 2016 … if the FDA would like to see a DDI study they would request it in 2016 (as the latest)

All together: the application DO NOT raises ANY, NEW significant issues on the safety and/or effectiveness of the drug …

Best,
G

[ggwpq]

MRC, "safety and/or effectiveness of the drug"? Repatha is neither safer nor more effective than Vascepa, yet it requires no AC. As a result, no AC for REDUCE-IT sNDA.