I don't think it is PH3 for once a day Oxy. But there are divergent paths that are unclear to me. If Oxy is off patent, then a 505B2 would be in order as a generic. Do they get to use the PH1 and 2 data from the trials to support this product? There is much that is not clear except the end game which is a generic ART opioid.

505B2s do not require a full blown PH3. These can be studies too but not just BE studies but it gets more complicated as you go through it.