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ORBAPU

04/22/20 10:19 PM

#268436 RE: breathofthenightwind #268415

How do you demonstrate bio equivalence without repeating the REDUCE-IT trial? Obviously, if the drug molecule is identical with identical purity (~96%), the non-drug chemicals (~4%) are identical, and the capsule materials are identical, no problem. The question is, how much deviation from identical is permitted?