Replies to post #349809 on Amarin Corp Plc (AMRN)

[sts66]

I am 99% sure GV had to meet some kind of peroxide specs so they were equivalent to the RLD, V. To say FDA would approve a generic for a drug that is highly sensitive to oxidation w/o requiring the manufacturer to prove it was stable and unoxidized defies common sense.

[marjac]

Assuming this is true, and can be established through scientific lab testing evidence, all we would need is one person subscribed Generic V to be lead plaintiff, and I could bring a Class Action against the generics for violation of the New Jersey Consumer Fraud Act ("CFA") for an unconscionable and fraudulent commercial practice.

The basis for the claim is very simple. A company cannot purport to sell and represent Product "A" as the "biosimilar" product, but instead actually sell Product "B" an inferior product. It is a textbook CFA claim.

Hikma is in Eatontown, NJ, and Reddys is in Princeton, NJ. In fact, if one of the lead plaintiffs is from New Jersey, we could file suit in the Monmouth County Superior Court where the courthouse is a mere 24 minutes from marjac's bunker.

In fact, this is the type of case, even more so than the infringement case, where an injunction could be obtained forcing the generics to remove their alleged deceptive, inferior, fraudulent product from the market. As long as the scientific and expert testimony factually backs up the claim. Talk about a potentially viable deadly legal blow to our generic tormentors, this is the real deal.

[johngnatt]

I am OK with your statement if you want to say FDA is not doing their job of regulating the quality of pharmaceuticals.

There are CHAMP regulations that are required to be followed. If a Mfg can flaunt them , they will.