News Focus
News Focus
icon url

Number sleven

12/30/24 7:54 PM

#431990 RE: Whalatane #431989

Kiwi, I understand your opinion. The FDA apparently has a different one. I haven't fully researched this yet ;however I have done a fair amount of DD. Bio equivalence is the FDA standard. If the self emulsifying version delivers the same bio equivalence, it's good. Not that different from ANDA approvals. Once again, this is academic only. Amarin has made no announcement about going down this road.
Sleven,
icon url

Number sleven

01/01/25 6:40 PM

#432021 RE: Whalatane #431989

Kiwi, If you wouldn't mind. Post a link that supports your humble opinion.
Sleven,
icon url

JRoon71

01/02/25 8:39 AM

#432024 RE: Whalatane #431989

But I don't think the new formulation is more concentrated, it just has a lecithin emulsifier, correct? I know I am over-simplifying it, but I was not aware that the IPE concentration was any different. So essentially, same active ingredient, just a different delivery system.

I would assume they need a short safety trial, but I doubt they need a REDUCE-It - like trial.

Plus, there is all kinds of data on the internet about the combination of lecithin and EPA. It seems that this is a widely studied mechanism.

As a side-note, some of what I read seems to indicate greater EPA uptake into the brain when combined with lecithin and/or LPC. I wonder if a longer trial (than BRAVE) with the new formulation would prompt better outcomes for ALZ treatment.