My question: Can Amarin sue FDA for changing their mind on Reduce-It study?
This will be a way to show:
1) Vascepa acts differently than Lovaza or other Fish oils.
All lower Trigylcerides,but Vascepa lowers C-RP by 21%--not shown for Lovaza.We know Lovaza raises LDL-C by 45-49%.
2) Bring in Japanese experts who have analyzed JELIS data--to show EPADEL works by lowering Inflammation--Japanese use AA/EPA ratio--where as Amarin measured C-RP
3) The whole advantage of Vascepa-like Epadel in Japan is reduced CV events thru inflammation reduction which was proved statiscally in 2011 article in Atheroscl.journal.
4) Hire Dr.Barry Sears to testify--he is an expert on Fish oil and Inflammation.He sent me 2011 article long time ago.
you were told very wrong. fda action actually exposes them to more risk since they did it after requiring the company to spend and reach all endpoints in the agreed to trial design. they CAN be sued and WILL BE liable--question is, is it in AMRN's best interest to sue???
The FDA did not withdraw the Reduce-It study, they rescinded the Anchor Spa. In my opinion, this was an error on the FDA's part. I have been researching this over the weekend and plan a detailed post on the subject tomorrow morning. I also think that the ADCOM erred in its dismissal of the JELIS study. I will also address this tomorrow.