They did not used the "active ingredient" approach, but revised ingredient / moiety analysis(1 to 1 instead of 1 to many regarding AI - AM relation) during the new determination, resulted in NCE.
I thought the Judge wrote/said - The FDA must use the ingredient, rather than moity for determining NCE, as defined in Hatch-Waxman law!
I would like to see the FDA in front of this Judge again, deciding NCE case!
I agree with you that the 6 months is the conservative expectations, it is the longer end of the time curve. However, I give 0% probability to "AMRN and management is planning to surprise us as early as tomorrow".
Thus Tuesday's presentation could be defined as the ultimate deceptive "Trojan Horse" no?