InvestorsHub Logo

johnking29

02/09/14 12:59 AM

#25191 RE: ggwpq #25190

ggwpq - No proven benefit in the eye's of the FDA (I could have added that yet thought it was obvious...) If the FDA thought or thinks there is a Proven Benefit or reducing Trigs below 500, they would or should or still can approve Vascepa with a modified label...

As of now they have NO PROOF of a Health Benefit of reducing Trigs below 500.

I like you completely disagree with that position YET the FDA is fact driven so once Amarin can produce something that shows a benefit of reducing Trigs below 500, we can apply for that benefit and sell the drug for that reason (with the FDA's backing)...

The key is to get their backing. They are basically the Gate Keeper to Doctors...



sts66

02/09/14 12:37 PM

#25203 RE: ggwpq #25190

Treating TGs 200-500 alone isn't the issue for ANCHOR, as we now know - it's trying to claim that treating them with a statin is going reduce CVEs, not proven according to the FDA - other research says yes, but they don't want to listen in this case. Recall they said they were making AMRN a "test case" for evidence based medicine, not allowing reduction of a biomarker to be the endpoint.