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Saturday, June 01, 2019 11:09:18 AM
In GIA scenario it seems like complete mismanagement of an asset. In BO scenario seems like filing being further along would be better, is Amarin really afraid of not filing correctly and leaving for BP? The basically stated they probably want to file and have approval before partnering there to "de-risk". Well faster approval, means faster EU partnering!
This question has never been answered well by JT, I can get they can wait to partner, more value after FDA approves and EU approval theory, but then why not prioritize the EU filing? What are the people that did the US filing doing with themselves?
For 6+ months they have said:
While we have received expressions of interest from companies regarding European rights to Vascepa. We have not decided, whether who is best to partner in Europe before de-risking the regulatory process or if it is better to wait. There are pros and cons to both approaches
Maybe I can help them Google decision making models. Are they waiting or are they not? List the pros and list the cons and make a decision, this takes more than 1/2 a year to decide?
I'm pretty sure they are not completely incompetent which the above info suggests. I think they realize it's indefensible to be so slow on EU, especially when they stated there are "slight differences" between US and EU filing, thus the brush off answers, which only leads me to believe they think there is no way they are ever going to have to worry about it since it will be the concern of BP.
So after the SNDA is submitted, we will turn more attention to the prioritization in Europe. Key there is that the data that will be submitted to the FDA with slightly different format should be the basis for the filing for Europe,
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