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OldYeller187

11/30/18 2:47 PM

#164263 RE: HDGabor #164190

Hi G,

It's a really good question, and something I have wondered about myself. I wasn't sure if maybe I was just missing something, being new to the company and not knowing the whole history.

My only guess at the moment is that it is probably due to commercialization reasons, and also maybe lack of a partner to facilitate that. But still, it is odd to me.
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sharinky

11/30/18 3:21 PM

#164271 RE: HDGabor #164190

The good news is that in the EU they will have new chemical entity status when they do file with a bigger indication right from the start.
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funnygi2

11/30/18 3:34 PM

#164277 RE: HDGabor #164190


HD - re 164190

I always thought it was this:

Also under the Laxdale agreement, upon receipt of marketing approval in Europe for the first indication for Vascepa (or first indication of any product containing Amarin Neuroscience Limited intellectual property acquired from Laxdale in 2004), we must make an aggregate stock or cash payment to the former shareholders of Laxdale (at the sole option of each of the sellers) of £7.5 million (approximately $9.8 million as of September 30, 2018).

From page 46, 10q 9/30/18
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circuitcity

11/30/18 3:54 PM

#164280 RE: HDGabor #164190

Very good question, deep thinker! What is your take on this?

My personal guesses:

1) EU approval is not automatically guaranteed even if with a fda approval on hand
2) marine label is too small, not worth the effort and budget given pretty tight sales capacity and budget.
3) did not land a partner
4) focus on RT