Replies to post #40984 on Amarin Corp Plc (AMRN)

[HDGabor]

??? How do you mean it?

Anchor population: 200-500
Reduce-It pop.: 150-500

I see 2 scenario only:

1.) Based on interim analysis DMC recommend the stop and AMRN accept, data will be unblinded.
- the study will run till completion, but for safety and long-term eff. follow-up reason, the study will be "biased" from this moment
- AMRN will submit an sNDA, as Reduce-It.

What is the reason to force sNDA approval (ANCHOR) for a smaller pop. with Limitation of usage on label (eff. does not confirmed), when they could submit a new sNDA for a larger pop. (R-IT) w/o Limitation of usage?

2.) Based on interim analysis DMC recommend to continue the study, data will remain blinded to AMRN, they could not submit anything to support ANCHOR approval.

ANCHOR could be approved if FDA will change their mind, but it is not R-IT related.

Maybe we will see a 8-K on Tuesday. It's MLK weekend ... :-)

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Re.: Nrx - I am not so impressed either with NRx or especially with refill numbers. The base was low. We saw bigger NRx on 11/07/2014 and refill in 12/05/2014 ...

[Whalatane]

STS ..agree ..Kiwi

[couldbebetter]

From comments of management it sounds like they see some kind of potential opportunity from the interim look. None of know exactly what they have in mind. As to halting the study early for efficacy the FDA does give their opinion on that as well. For whatever reason I think that AMRN wants to get to this interim look point without dilution. Maybe they will sell the company at such a point if results are strong enough...once it is clear that Vascepa will be a billion dollar drug BP will want to buy it. The only way that happens is if Vascepa shows a positive benefit of 15% or higher. Waiting for final results of this study, if needed, would add an additional 1-2 years which means 1-2 years of BP not getting the revenue that they could have. Just my own speculation here but could it be that AMRN has the interest of BP and may be willing to make a bid based upon interim results? The problem that I see is the longer the study continues the more likely it will be that the results are even better than what the interim may show.