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antibluechip

04/30/24 11:40 AM

#423682 RE: Whalatane #423679

Kiwi, Excellent Proposal and Instruction on Power/Significance.
Along the same lines, do you think there are enough of us who have been on Vascepa for 5 years or more( typically after some intervention or detection), that could form the basis for a "post analysis" of subsequent "heart events," "plaque change," or similar markers? And I suppose a comparative non-Vascepa group could be identified easily.
As an example, I have been on V for 10 years after a CT scan and Heart Catheterization showed 3 serious blockages. As a researcher, I have always been hoping for a followup Heart Cath to see what if anything has changed. But cardios don't do a followup Heart Cath unless you present symptoms. Seems that individuals in my situation would yield some valuable data for just the cost of a 2nd Heart Cath. And of course others like me who ended up with stents, would seem to be an even larger group of candidates.
Thoughts, Ideas?
Dave
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Snd101

04/30/24 12:21 PM

#423685 RE: Whalatane #423679

Thanks for sharing your thought process. I agree that approval by France, Germany and Italy is one of the major keys to success for Amarin. Is the path to get there is via running custom trial that these three country would like? I am not so sure. It would be a surprise if those three countries agree to a common clinical custom trial. Even if they do it’s not an binding agreement that they have have to act according to the trial outcome. Government changes, health dept official changes. Running a custom trial to satisfy a specific health official defeats the purpose of running a trial to get FDA approval. It’s sets a wrong precedent. It basically makes the process of inventing new medicine and commercializing it at scale unsustainable. I am sure there are other more efficient methods to provide answers to the technical/medical queries of these health officials. If that is really blocking them for accepting the drug. But I believe the real reason for these health officials is not the concern about the medicine itself, but it’s something else. They are just using the data about the medicine as a false wall. You run a trial and alleviate their concern, they will come up with another concern. So no matter what trials you run for them, it’s going to be the same story. Bottom line is addressing the real reason behind their hesitance to embrace the drug and I believe Amarin is working to address that instead of jumping in to start another trial to satisfy them. My thoughts.
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rosemountbomber

04/30/24 12:32 PM

#423687 RE: Whalatane #423679

Am I correct in saying that what you are talking about is simply data collecting, analyzing said data, and tabulating results?