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eightisenough

09/10/20 8:45 AM

#297974 RE: Cardiologymd #297967

IMO This ISN'T off label. Off-label is: "the use of pharmaceutical drugs for an unapproved indication or in an unapproved age group, dosage, or route of administration".

In our case there is an approved indication which ONLY marin owns.

Do you agree?

8

ziploc_1

09/10/20 8:45 AM

#297976 RE: Cardiologymd #297967

Card...in the AZN vs. Apotex case...QUOTE from the court..."the court held that a manufacturer that intends to place a drug on the market knowing it will be used in an infringing manner by some consumers would be liable for inducing infringement, for which the appropriate remedy is an injunction. The court said it did not matter that the
infringing use was mandated by FDA requirements, because
the manufacturer had other options for avoiding inducement."

I believe this definitely applies to Amarin's Vascepa being used by Generics for the R-IT indications.

amarininvestor

09/10/20 8:24 PM

#298180 RE: Cardiologymd #297967

Cardio,

I think you talk frequently with Vascepa sales rep. If so, what are they saying about the situation?