Will AMRN be rewarded with exclusivity for spending $150M on reduce it, or will the FDA open the flood gates to generics? If it was my $150M, ( and it is), I would not continue to throw money away. Let someone else pay the tab...
I'd rather see Amarin use their cash to drive scripts, build their brand and fund lawyers... They are going to need them...
If you can clean up a potion of various compounds enough so it removes a very significant adverse effect, LDL-C raising, and you also find out that it does not have an Atrial Fibrillation tendency, then YES! FDA should encourage companies to CLEAN up potions that may contain harmful compounds in order to benefit patients. COMMON SENSE!!!
Reality is, people should be up in arms over this... Why? Because we can essentially have another case where a superior therapy is tossed into a mix of compounds and is given NCE exclusivity which likely prevents anyone from examining the individual components of that mixture to see if they are in fact better options.
And if they are better options, then the investigators are not rewarded for their findings.
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