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Re: Whalatane post# 431989

Monday, 12/30/2024 7:54:06 PM

Monday, December 30, 2024 7:54:06 PM

Post# of 447908
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.
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