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mopar44o

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mopar44o

Re: None

Wednesday, 12/02/2015 8:41:19 PM

Wednesday, December 02, 2015 8:41:19 PM

Post# of 38634
Rexista™ Oxycodone XR

Positive FDA feedback in May 2015

Rexista™ allowed to proceed with NDA filing

Rexista™ requires no Phase III trials provided we demonstrate bioequivalence

Previous Phase I Pivotals suggest bioequivalence conditions met

Rexista™ with PODRAS™ granted Fast Track designation by FDA


Clears up any muddy waters there for anyone still unclear.
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