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Biobillionair

10/13/15 9:28 AM

#61355 RE: Sam81 #61346

Thanks Sam...good information and no doubt shares an insight into how settlement is viewed as an upside.

Interim confirmation in 2016 is no doubt an important factor leading to a broader indication prior to this look. No doubt some pushy investor would make the FDA look pretty smarmy if this wasn't the case.

Ex-USA deals will fund cash needs...more...rather than BIG IMO.

IMO US deal may be pushed back until after full RI...

JEFFERIES mentions ANCHOR impact....unclear if this is Anchor on or off label. IMO it would behoove FDA to grant on label and get First Guidelines out so they don't find themselves in court in a continuing basis.
***clearly this is off-label***. This is a calculated risk by FDA perhaps to mitigate legal exposure...a mistake IMO.

I don't expect 10-30 joint letter ends settlement...this is just the start of a long painful (for FDA) process.

Again thank you Sam for sharing your DD!

BB

sts66

10/13/15 12:38 PM

#61387 RE: Sam81 #61346

Future modules are planned to detail inflammation benefits of Vascepa and the Japanese JELIS study that showed a CV outcomes benefit for E-EPA

Those are the two biggest ones right there - especially the inflammation benefits IMO - although I'm sure many will argue JELIS is more important - just going on my own personal experience here, with how V has reduced chronic inflammation issues so much that it's literally changed my life for the better.

Danburydude

10/13/15 3:30 PM

#61397 RE: Sam81 #61346

Reading between the lines, this is what I see . I think some partnership deals are waiting to be signed. AMRN is planning on doing partnerships , so they don't have to do any more financing. The amount of partnerships , and at what price is still to be determined.
AMRN just needs more clarity on NCE and the First Amendment lawsuits to pull the trigger on further deals . What I found extremely interesting is the reply someone got about an inquiry into the recent share rewards .
I believe the company responded no comment at this time, but the reasons will be revealed by next March / April . That would put the anticipated time frame for clarity on these issues into next spring at the latest .
REDUCE - IT interim stop fans can look at that and say wouldn't that fall into the time frame of an interim stop ? It might . That kind of logic cannot be ruled out .
There is more to the story than has been revealed. Definitely something is in the works. A little more clarity , and we will see what is being cooked up .