Replies to post #308762 on Amarin Corp Plc (AMRN)

[Baillotek1]

@ STS what the hell is wrong with you. How aggressive your post sounds do u realise that ?

Still answering you though because I recognise the quality of some of your other posts :

Did I write anywhere in my message that the net content of API is not an issue ? Of course it is..
Total weight of the pill (V & gV) is going to be more than 1 gr because it contains 1 gr IPE + the antioxidant + the non active ingredients.

Have a look at the ANDA, the FDA would not approve the pill if it was containing 600mg or even 950 mg of IPE.. They acknowledged bioequivalence for 1gr IPE +- few mg, not less than that and not more than that.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209457Orig1s000ltr.pdf

The message I want to give here is there is no point to look for cavits in the non active ingredients of gV pills. the critical point here is the API purity and residual content of impurities that can be there as traces for gV, and not there for V. The less impurities, the higher the purification cost.

There are marketing/strategic implications there as Vascepa is promoted as being DHA free.

Baill