Amarin Corp Plc (AMRN)

[johnking29]

sts66 - You are 100% correct...

I called Joe Bruno right after Adcom (speaking directly to him for a half an hour or so) and asked if Amarin's goal was to just get an extension of Marine (which makes NO mention of Treating people at Risk for CVE's) to treat those in the 150 to 499 Trig group then why did they add "...Treating People at Risk for CVE's" in their application..

His reply is exactly as you note: "It is normal to list your ultimate goal on the label..."

In my opinion that opened up a pandora's box so large that the FDA just said NO WAY and propelled us into 2017 without an opportunity to "apologize for the mistake"...

I am still hoping to get the extension of Marine to treat those in the 150 to 499 group yet on the other hand I concerned that there currently is no proven end point in the FDA's mind (or "reason") to treat people with that level of Trigs.

In theory we are creating the reason with Reduce-It so why would they give us an OK to treat the 150 to 499 class with their new "must have a proven endpoint" position...


Do you know if Lovaza ever applied for this class and if so how was it received by the FDA?

It is all quite a quandary!

How do you get an approval from the FDA for something that the AHA feels is necessary if there is no proven endpoint and right in the middle of the FDA closing the door to "No Endpoint Approvals"?

I think we need a sponsor with big money like GSK on board - someone with deep pockets who we can work closely with that might help us all cross the goal line with the FDA... AND who can help us start running new Endpoint Testing for other uses of Vascepa.

I have NOT closed my mind to getting the extension as a negotiated agreement YET I suspect we will end up getting a Freedom of Speech ok to add the info to the label...

I like you have no need to sell... I am not emotionally attached YET in complete agreement with the science and feel/know sooner or later that it will succeed!

Here is what I always turn back to:

Warren Buffet once said:

If you plan to "Invest" in a company and/or product, plan to be in for at least (10) years and have no immediate need for the money!

In my case: 275,000.00 invested with a current approx value of 30,000.00.

Works for me and let's me sleep at night!

John