Replies to post #14762 on Amarin Corp Plc (AMRN)

[Biobillionair]

JL Looks like Amarin will have full enrollment early 2014 if the current enrollment pace continues.

It's hard not to notice Astra's "news":
9-24-2013
"The acquisition of Omthera Pharma added Epanova to AstraZeneca’s pipeline. The candidate has been developed for the treatment of patients with severe hypertriglyceridaemia (triglyceride levels greater than or equal to 500mg/dL). The U.S. Food and Drug Administration (:FDA) accepted the marketing application for Epanova and is expected to render a final decision on the candidate by May 5, 2014."

"AstraZeneca also intends to get Epanova approved as a fixed dose combination with its cardiovascular drug, Crestor, for mixed dyslipidemia patients who are at a high risk of cardiovascular events. Moreover, AstraZeneca is planning to conduct a large scale cardiovascular outcomes trial to assess Epanova in combination with statins."

http://finance.yahoo.com/news/astrazenecas-stage-pipeline-154008313.html

AZN'S STARTING TO SOUND DOWNRIGHT DELUSIONAL. CAN EPANOVA BE APPROVED FOR SEVERE TRIGS?...A BIG MAYBE!!! AMARIN'S VASCEPA NEVER NEEDED AN AD COM FOR TRIGS >500 BECAUSE IT HAD NO SAFETY SIGNALS THAT WHERE APPARENT. FROM A PHASE 3 TRIAL WITH EPANOVA THEY SHOWED BLOOD LEVELS OF DHA MULTIPLES HIGHER THAN LOVAZA, THIS IS CONCERNING SINCE LOVAZA'S RAISES LDL AND COMES WITH AN A-FIB WARNING. BEFORE APPROVAL FOR SEVERE TRIGS, AZN'S GOING TO HAVE TO PROVE, AT THIS AD COM, THAT IT DOESN'T HAVE THE SAME CONCERNS LOVAZA HAS. (IF I HAVE TO PERSONALLY GO MYSELF TO RAISE THIS ISSUE, SO BE IT) BOTH OMTHERA'S PHASE 3 STUDIES ARE SPA DESIGNED, YET THEY ARE CALLED IN FRONT OF AN AD COM FOR THE MERE SEVERE TRIG INDICATION.

YET, AZN IS LOOKING PAST EPANOVA'S SEVERE TRIG APPROVAL AND ONTO COMBO EPANOVA/CRESTOR FOR THE TREATMENT OF HIGH TRIGS, SOMETHING THE FDA HAS REQUIRED AMARIN TO DO A CARDIOVASCULAR STUDY TO APPLY FOR THIS INDICATION. THE PATENT WILL EXPIRE ON CRESTOR BEFORE THEY GET THEIR FIRST PATIENT ENROLLED IN THIS "large scale cardiovascular outcomes trial to assess Epanova in combination with statins".

MY POINT? AZN'S TALKING SHIT! AT THIS STAGE IN THE GAME THEY ARE S.O.L. WITH THE EPANOVA PLAN. I EXPECT THEM TO BE THE FIRST "OFFER"...AND THE TIMING BEFORE OCT 16 TO PUT PRESSURE ON AMARIN STOCK HOLDERS TO SETTLE WITH LESS BEFORE ANCHOR PDUFA.

MOST ON THIS BOARD WOULD SETTLE FOR $20-30... I WILL NOT AND DOUBT THAT AZN CAN COME TO AN AGREEMENT WITH THE BOARD.

AMARIN SHOULD CONTINUE GIA, AS BREAKEVEN SALES ARE FAST APPROACHING, AND MANAGEMENT HAD THE BRAINS TO RAISE CASH FOR DIRECT ANCHOR MARKETING.

I'M IN THIS TO SEE REDUCE-IT GET IT'S JELIS OFF:)

WILLIAMS

[imthomascrown]

JL - Re: arthralgia

At risk of "focusing on the negative," particularly for a long term owner/accumulator of AMRN: the safety info at the end that mentions arthralgia (joint pain) as the main, or really only, adverse reaction still surprises me... any thoughts?

[KCSVEN]

I like how they throw this into the Reduce IT press release..


"An SPA agreement is generally considered binding upon the FDA unless public health concerns unrecognized at the time of protocol assessment are evident."

So why is it they could back out of Anchor approval?

Though I'm also not 100% convinced WS thinks Anchor has any chance of denial, sure minor overhang but think WS is more concerned with how AMRN will s ell Anchor, partner or dilution and GIA? So in the long run I expect they can get sales to a profitable level, I do believe the biggest overhang is lack of clarification for Anchor launch, not actual Anchor approval.

Then the overhang if GIA will be how are they going to raise money GIA to launch.

[BioChica]

That is great news! Enrollment is moving along nicely. I remember a poster stating that enrollment would not be completed for years. The argument was, trial enrollment typically slows down over time. My reply was "I doubt that! in the case of Vascepa" if anything, it may have accelerated. I think a lot of people out there want to participate in this trial, and have been turned away.