JL,
The FDA will not act anything regarding the sNDA, since they could not, till the appeal is ongoing. The action is different w and w/o SPA.
It is indifferent that SPA is a contract, agreement or assessment (btw: the value / $100M does not determine it). The rescission was totally legal as the director was entitled by the statue to do it.
I agree with you that the timing is unacceptable and their reason is weak, however I could not say and you could not guarantee that the judge will rules in favor of Amarin.
The business could not be run based on emotion, based on “right is on our side” on a long-term. The possible scenario:
a.) continue the appeal process, sue FDA, and win the case in 2017 after R-IT stopped based on interim: no gain
b.) continue the appeal process, sue FDA, and win the case in 2017 before the final result of R-IT stopped: gain app. 6-9 months
c.) continue the appeal process, sue FDA, and lost the case in 2017: no gain
d.) stop the appeal process, get a CRL without recommended actions: no gain and lost the opportunity to sue the FDA
e.) stop the appeal process, get a CRL with recommended, reasonable actions (ie.: resubmission in different form): gain something now (ANCHOR data on label w or w/o modified indication)
Amarin has to estimates the possibilities (short and long term, advantage and disadvantage). In case of “appeal and sue” no short-term gain and the long-term loss is small (poss. b.)). If they stop the appeal they could (not guaranteed) gain something on the short-term and they won’t lose too much (max. 6-9 months) on long-term.
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