Amarin Corp Plc (AMRN)

[HDGabor]

BB-

To avoid any doubt: nobody said that Amarin won't (try to) file a respond (I expect also) or that the reason behind the 2nd postponement isn't the result of Amarin request (I think, it could be) ... however it won't confirm / support your theory / statement that the first postponement was triggered by Amarin reply / request, since the the postponement process was started earlier (on Sep 22) than Amarin filed anything (on Sep 25).

The lack of your acknowledgement won't change this fact ...

Why Amarin reply is more likely than not?

a.) They (could not) won't let the FDA's request unanswered
b.) Maybe more "interesting" citation could be find in FDA's request, but at least one:

the Commission’s Staff correctly recognized: “the Staff believes that a cause of action is likely not precluded by the FDCA if it does not require the Commission to directly apply, enforce, or interpret the FDCA.” See Staff Response to Respondents’ Motion for Summary Determination Dismissing Claims Precluded by the FDCA in In the Matter of Certain Potassium Chloride Powder Prods, lnv. N0. 337-TAl0l3, EDIS Doc. l.D. 593245 at 4 n.2 (Oct. 21, 2016) (emphasis added). A fortiori, the FDCA would preclude such a claim if—as is the case here—it required the Commission to directly apply, enforce, or interpret the FDCA.

Yes, it was said by the Staff (Office of Unfair Import Investigations) as Footnote 2, however the FDA "forgot" to mention that the relevant case was similar to the current case (non-approved drugs) and the:
- ITC instituted the investigation
- the OUII opposed the Respondents' motion

certain allegations in the Complaint, which allegedly require the interpretation, application, or enforcement of the Federal Food, Drug and Cosmetic Act
(“FDCA”), are within the exclusive jurisdiction of the Food and Drug Administration (“FDA”).

as

Stated differently, the allegations identified by Respondents are not necessary elements of the false advertising causes of action. 2

Summ: meanwhile FDA motion (it is scientific review) could be true / accepted by the ITC in this case, the opposite is true also ... none of the outcomes have a 100% (or high) probability.

Best,
G