Amarin Corp Plc (AMRN)

[Mellowmood77]

The FDA is being backed up into a corner.

They might use every tactic they can to delay expanded label, but that’s all they will be able to do... delay.

The late adcom announcement and thus delaying (or are they?) PDUFA was their latest trick. The truth is they were humiliated and embarrassed by the 2 lawsuits they lost and are worried about the SC petition. They can’t stop this train however.

They are now going up against the AHA/ADA/ACC (usually follows AHA)/BHATT/ICER/NJEM. But who are they afraid of most? Journalists.

I emailed Charles G Seife, the journalist who sued for FOIA documents regarding Sarepta’s DMD drug that made a mockery of the FDA. He responded:


Hello, Mr. *******

I haven't looked at this case in detail, so take my impressions with a grain of salt.

The adcom stuff is weird -- but I'm not sure that I'd attribute malice beyond FDA's normal way of doing business. There appears to be differential treatment on occasion, but, typically, it's not because of company history but because of the nature of the drug -- my impression is that first-in-class and "important" drugs tend to get more favorable treatment than others. (Formalized in the AA process, informally as well, though.) I can't recall a case where FDA seriously penalized a company for past practices (even when it was well deserved) -- I've seen bias *in favor* of a company because of circumstances, but not *against*. So my inclination would be that this isn't arbitrary and capricious above and beyond the usual arbitrariness of the agency. But that's me shooting from the hip... there might be more there than I see right away.

Cheers,
Charles

Let’s see what happens when he pokes in a little further?

The FDA will play a LOT nicer with a journalist on the people’s side. I doubt they will deny millions a life saving drug while they are in the spotlight!