I listened to the ELTP call.
As best I can tell (the accent of the CEO was a bit thick at times), they do testing with various foods to verify onset of the active drug is the same as the original (Oxycodone XR).
From what I was able to pick up, there was a delay in the onset of the active drug when tested with fatty foods.
As described by the CEO, the FDA was concerned about this delay with fatty foods, because they thought that a patient might decide to take another dose of Oxycodone, since the effect of the original dose wasn't kicking in.
In order for the label to say "with food or without food", it has to have consistent onset of the effects of the drug.
The ELTP CEO sounded really ticked, as he felt that the FDA should have flagged this in their early discussions as an issue.
If anyone else heard differently, feel free to correct me.
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