KJD, given the time you spend on CORT maybe you should read a bit more....
FDA tentative approval is based on a proposed label. That has not publicly been disclosed by Teva. Since that was all done long before the two most significant patents were granted (combo dosing with CYP3A & dosing w food) it is a good bet that it is virtually identical to the Kormlyn label (of Corcept) which talks about CYP3A combo and of dosing with food with titration to 1200 mg.
Skinny label means when the generic goes to market with a label that omits part of what is the brand drug label (in this case Kormlyn) to avoid infringement of certain patents that the brand company has.
To be successful with a Skinny label the generic company needs to (1) get FDA approval that the skinny label does not effect the safety or efficacy and (2) in litigation get the court to agree that the skinny label after the carveout does not directly or indirectly infringe on the claims in the patent (that is no inducement to infringe).
Of course the brand company, Corcept in our case, will argue at the FDA that the carveout for CYP3A does effect safety and carveout of the high 1200 mg dose does effect efficacy via a petition at the appropriate time (that is after the revised label w carveout). And as for the litigation, CORT will argue that it is direct infringement (if Teva keeps 1200 mg in label) or induced infringement (if Teva say restricts the label to 900 mg, assuming they get FDA OK) with the judge ultimately deciding this way down the road. While all this is in the air IMHO Corcept is likely to be successful in getting a court injunction to prevent an at risk launch.
Hope the above helps you finish connecting the dots in my last post. Bottom line is the effect of above IMHO is likely to push any generic until after Relacorliant arrives....