Amarin Corp Plc (AMRN)

[Mellowmood77]

Raf, they might have been forced to due to mandate.

“the FDA could not delay approving an ANDA due to concerns raised in a citizen petition unless the delay was "necessary to protect public health"; it also mandated that the FDA needed to respond to a petition within 180 days - this was shorted to 150 days in a 2011 amendment”

If the FDA felt the CP provided enough of an argument then by mandate they would have to take action on it. I am not sure if they treat sNDA’s and ANDA’s the same way, as even the new guidance everyone is talking about has to do with ANDA’s.