Based on the Amarin reply to the defendants Motion to Compel, I think there’s a good chance the court rules for defendants on the motion, and that Amarin will have to produce the balance of post-SNDA FDA correspondence that they have been withholding. Amarin’s procedural argument, that defendants are unnecessarily requesting additional discovery after the discovery deadline, is countered by a not unreasonable argument from defendants that there potentially is materially relevant content in the withheld FDA correspondence. Amarin calls that a fishing expedition, but I think there’s a good chance the court won’t agree with that. Amarin’s second argument, that the request is unduly burdensome and broad, is weak. The correspondence that has gone between Amarin and the FDA since the sNDA submission can’t be that voluminous, especially relative to the thousands of pages of REDUCE-IT docs that Amarin has already provided, so they really can’t argue that it’s burdensome to provide that correspondence. It would take a few hours to compile them and forward.
So I think the court is likely to rule that the requested docs are potentially relevant, and not difficult to provide, and therefore should be shared with the defendants.
I guess what concerns me is, why is Amarin so sensitive about the FDA correspondence? Thero explicitly stated in the infamous Adcom conference call that no public announcements would be made going forward regarding sNDA-related correspondence with the FDA, as it would be a “fluid” process. And now Amarin, who I continue to believe has a strong position in the patent litigation, is making uncharacteristically weak arguments to very specifically shield the post-sNDA FDA correspondence from view. I suppose it could be simply an “it’s none of your business” argument, but it somehow feels like more than that. I can’t help but go back to the worrisome Adcom conference call, where Thero, who’s generally a pretty collected guy, seemed unraveled, and wonder what he’s hearing from the FDA. I was hoping he would bounce back for the latest investor presentation, but he still sounded broken.
It will be reassuring to just get to the Q3 earnings announcement, hear great numbers for the quarter, maybe raised guidance, and just a little more bounce in Thero’s step. In the meantime, I think the litigation drags on in the background, and will likely be a not insignificant drag on share price. Assuming label expansion is granted, the patent litigation will be the last remaining leg for the shadowy cabal of Amarin opponents (DS?/Generics?/BP?/Shorts?/MRC?/all of the above?) to stand on.
