Looks like it will all come down to whether or not the Advisory...

Looks like it will all come down to whether or not the Advisory Committee panel and the FDA view the purported reductions in deep oxygen desaturations (i.e. SpO2 < 80%) as enough of a safety advantage to approve Moxduo, especially in light of the fact that Moxduo results in a higher frequency of shallow oxygen desaturations (80% < SpO2 < 90%).

In terms of how much of a safety advantage may be deemed sufficient, the QRx briefing materials note:

"After discussion at various levels within the Agency, the FDA agreed that QRx could satisfy the Combination Rule by demonstrating, in Study 022, evidence for a safety benefit of Moxduo relative to comparable doses of morphine and oxycodone through post hoc safety analyses. The FDA also stated that this benefit need not be to a level of that needed for a label claim."

In support of this, they quote the following correspondence from the FDA, dated 31/10/2012:

“If review of your arguments regarding a safety advantage were considered robust by DAAAP, this could potentially lead to approval without the level of evidence necessary for a comparative claim within the Indications and Usage section.”

I guess we will know soon enough.