ACR - Efinaconazole, page-32

The various approval timings will be simply a function of FDA's assessment of the initial submission and the subsequent Q&A's that follow in relation to the data contained in the dossier. Whilst a generic has to be the same as the brand (or within very minute deviations), things happen in manufacturing process and deviations occur within the sample statistic data that need to be explained or at worst samples need to be re done.

The luxury of the delays for this dossier is that the market has not formed due to the litigation, so as long as we are approved before an outcome of the litigation its ok. That said the delays would be costing ACR $$ as they address FDA queries.

Delays are really costly when you are racing to enter a market (no legal restrictions) as generic entrant 1,2 or 3 but it turns out you are generic entrant 4,5 or 6.