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namtae

08/19/16 11:14 AM

#222542 RE: elichen #222541

By this very definition, Sequests Tmax delay was not BE

If SequestOx fed Tmax is equal to or less than 3 hours 45 minutes, then it is already bioequivalent to Lehigh Valley NDA #200-534 and could be immediately approved in 5mg size if RLD is changed.



Add to this the circumstantial evidence of withholding from the public ONLY THE Tmax DATA from the BE study and CRL CC and its not hard to connect the dots