Replies to post #219670 on Amarin Corp Plc (AMRN)

[sharinky]

I don't know the process in great detail but I would think once the EMA rules on the accelerated approval we should pretty quickly see the actual EMA filing be made.

New Reduce-it patents being in place before filing are going to be a great bonus for longevity of the patents in Europe.

[HDGabor]

N-

(i) Rapporteurs’ recommendation on the request for accelerated assessment (top of Amarin):
1.) autologous CD34+ enriched cell fraction that contains CD34+ cells genetically modified ex vivo using a lentiviral vector encoding for the human arylsulfatase A(ARSA) cDNA sequence - Orphan - ATMP - H0005321
2.) valoctocogene roxaparvovec - ATMP - H0004749
3.) BALOXAVIR MARBOXIL - H0004974

(ii) The decision will be "published" by Friday (could be available earlier ???)

(iii) submission: Nov 11 (in case of Standard Review: could be Nov 25)

Best,
G

ps.: I do not have a tin foil hat … Dr. and "Killer" are not the best business advisor ...