Replies to post #51676 on Amarin Corp Plc (AMRN)

[north40000]

Speaking of the Amarin et al complaint in the SDNY, here is a nice summary + link to the actual complaint:

http://druganddevicelaw.blogspot.com/2015/05/amarin-v-fda-focuses-spotlight-on-first.html

I had lost my link to the complaint---it's useful to have it again to see what the [b]amicus briefs are supporting, and what the FDA is fighting or trying to make moot, per Dr. Woodcock's letter last Monday.

BTW, Dew thinks the judge will grant FDA summary judgment or say that the case may not be ripe for review.

I do not understand his position nor what little rationale he presents to support his opinion.

[rafunrafun]

You bring out an interesting topic - defense side = FDA + DOJ attorneys. We saw what a joke JW's letter was, did she run it by the DOJ attorney before submitting it? I speculate that FDA's general counsel saw it but not the AUSA who defends FDA. My reasoning is because quiet freely, the AUSAs aren't that stupid!

Now I brought this topic up when the Complaint was filed - will FDA and AUSA be on the same page? I highly doubt it. No reasonable AUSA will defend this, she will tell FDA to settle. She doesn't have agenda like FDA has.

Can you guys imagine her reaction after seeing the the amicus briefs?

[zumantu]

Heysfguy, the 1st Amendment strategy is unfolding rapidly and I agree, it's very well executed thus far. One topic that's hasn't been mentioned is the effect this suit will have on R-T.
The bug pay-off will be the ability to immediately sell the confirmation of CVD risk reduction by (TBD)%.

Prior to the 1st Amendment suit, Amarin would have been at the mercy of the FDA for approving the sNDA for a new indication.
Assuming they win, Amarin will be able to exercise their 1st amendment rights - immediately - no lag, no latency

This accelerates revenue big time