>>The main significance of a decision upholding the lower court will be that the 180-day H-W exclusivity clock finally starts ticking. I understand. Does that make any difference to the FDA? Might they get on with approval BECAUSE the drug can get to market? IF those questions are answered in the affirmative then there may be some upside to affirming the trial court. Otherwise - we remain at the whim of the FDA. And who knows when they will act. ij