Amarin Corp Plc (AMRN)

[HDGabor]

K-

have experienced first hand, how things don't always go , as your high priced attorneys expect.

One of the attorneys expectation become true always, in every cases ...

HDG makes a convincing case on why the ITC will accept this investigation ...but I would like to hear it direct from the source ( HDG ) the % odds

I do not have an exact odds in my mind, but my view:

- Meanwhile we do not know the exact reason behind the delay, but it is less likely that the ITC could not rule "deny the investigation" w/o the delay. The more likely scenario that they think they have jurisdiction, but (e.g.) they would like to "double check" something (w or w/o external party) or they would like to get FDA preliminary opinion. The delay isn't unusual, but usually due to the request from a party and not from the ITC.

- I see Amarin reasoning as well structured: they do not want to enforce any part of the FDCA (e.g. they do not want label revision, force any action by the "DS" as the FDCA requires), they requested a "ball and strike" interpretation of the FDCA by the ITC: Are these ds or drug? ... and as a drug, their actions are a Section 377 case. (To avoid any doubt: ITC will inform the FDA about the case - if had not do yet -, could request advise / opinion from the FDA ... but could move on its own).

- In case of the investigation (as I expect) it won't be too long, since the case - looks like - black and white:
a.) all available (all that I know) information re. FDA's view about this type (synthetic) of product support the view: they are drug (not the omega3 product, but all chemically altered products)
b.) "surprisingly" (YTD) nobody submit / raise an argument, that these product aren't a drug ... why are they dietary supplement (To avoid any doubt: Amarin has not alleged that they are "new dietary ingredients" as could be "grandfathered")

- Meanwhile it won't be too long it will take some time as:
a.) ITC has to go throw the full process
b.) Proposed Respondents could submit the reply
etc. ...it won't be closed earlier than 2 / 3 months after initiation of the investigation

Even if they accept the investigation, I doubt if the remedy or Presidential review will go as far as Amarin hopes.

- What could be the "less / lower level" of remedy?
- I do not know why do you mystify the "Presidential review"? It is basically simple: no action or a veto ... and a veto is very rare (6 times only YTD).

Best,
G