Replies to post #417708 on Amarin Corp Plc (AMRN)

[Number sleven]

Laurent, I have no idea what clinical research would look like post BRAVE. Are you familiar with the most recent FDA guidelines for an Alzheimer's disease drug approval? Preclinical has the lowest bar for an indication. Positive effect on biomarkers. It is unclear if damage done during disease progression is reversible. This might be why FDA stratified the evidentiary requirements. How would you construct a large long term study on preclinical patients?
Sleven,

[Jasbg]

LM, A question from a non bio / med knowledgeable person ?
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Would it be possible (any precedent) to contact participants in the R-I trial - answering questions on their later dementive status ?

A portion will be dead - but R-I status is still only some 5 years away (2018) - the 5 years that have passed, might actually be a positive in this context - of 'following up on the later effect of Vascepa on the brain - in the big group of people.

Recognize that there will be a number of other challenges on the way - (some have stopped taking Vascepa in the meantime etc. ).

But feed the right data, from a group this big (even after eliminating all not statistically relevant participants) - into modern computer calculations - results would be extremely exciting to 'follow' - given the weight of the big double blinded R-I trial.
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If something like the above presented idea were possible - would be accepted by FDA as 'trustworthy relevant data' - in the fight against AZ and dementia prolems' - it could to some extent 'compensate' (in lack of a better word) - the totally unforseen / meaningless / 'based on fraud' - Judge Du ruling - back in early 2020 🙂