Replies to post #34937 on Amarin Corp Plc (AMRN)

[Whalatane]

Rais

Read the FDA " Guidance to industry "

When you are reading that ...note how many times the word Agreement is used.
Note how many times the word Contract is used .

The SPA is legally an Agreement ...NOT ..a Contract ....know the difference
JMO ...don't mind being corrected by those more informed then moi.
Kiwi
( someone who has written and signed over 600 contracts in the last 30 yrs and spent more time in court then hopefully all of the readers on this board combined )

[HDGabor]

a.) they have to go through the FDA appeal process before file the case. At least 2 levels (maybe 3) are remaining and that is at least 4/6 months, however could be longer 6/9 months - earliest time to file is Q2 2015
b.) it's not a slam dunk - max 50/50% as the best
c.) final ruling takes 2 years - mid-2017
d.) ANCHOR sNDA is pending until appeal is ongoing, DMEP could not issue the CRL, since they have to act differently w or w/o SPA

Which is better:
1.) wait additional 2,5 years for a possible, but not sure court ruling (and don't forget that R-IT maybe will be stopped due to eff. or the end of the study will be near at that time)
2.) stop to appeal, get the CRL and try to include the ANCHOR data on label w or w/o new, modified 200-500 indication