Amarin Corp Plc (AMRN)

[ziploc_1]

I flew to Washington in 2019,at my expense, to attend the FDA hearing, which lead to the FDA approval of Vascepa for CVD... During the meeting, I noted what seemed to me to be an unusual conservatism on the part of the FDA...possibly because Vascepa was a med, which the FDA apparently realized, had the potential for very wide use and which had not been that widely used, up until that time.

I think that is why the FDA insisted on Vascepa having an indication for patients, who have 150 mgs/dcl. or more...They also suggested that Vascepa have on its label...a "black box warning" due to potential side effects..Thankfully, this idea was dropped by the participants at the FDA meeting and they did not require the label to mention it.

Now that Vascepa has been used by millions of patients, we have greater knowledge of its superior efficacy and its placebo like side effects....so the 150 mgms/dcl. of TG imperative is not as necessary as it was in 2019.

My own TG has been in the range of 50mgs/dcl I and was eventually able to convince my cardiologist to prescribe Vascepa for me.