M - There are at least two different issues here.
1. Did gV meet the FDA's bioequiveloncy rules? Absolutely. Generics crossed all the t's and dotted all the i's, IMO.
2. But should those rules (FDA rules) be applicable to V / gV? The pills look and smell completely differently. In my limited understanding and as was explained to me but an expert, this is because Generics cannot replicate Amarin's patented encapsulation, which effects oxidation. I don't know enough about which tests are needed but I assume that Mason has been all over this on a molecular level, probably way more than what a simple oxidation test can show.
Again, this isn't scientific but:
A) Bright yellow, rotten fish odor
isn't the same as
B) Crystal clear, little to no odor
There is no scenario where these two are equal. But our issue is how "equal" is defined and can the FDA be convinced.
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