Hi Timber. Hope you are well and sorry this is such a late reply. Since reading your post i have had a very busy month and thats kept me off the HC airwaves.
Clearly there was something in the data the DFA didnt like or at least there were some gaps. Feedback from the post CRL meetings suggests gaps and that they can be closed with outcomes from the 022 study, which is more to do with safety and less to do with efficacy. In my view this makes sense since all previous studies met their agreed endpoints on efficacy specifically.
The FDAs willingness to set a precedent (same drug class combination) remains an open question for me at this point. I am however encouraged by the FDAs recent ruling on OxyContin which suggests the FDAs willingness to address the abuse issue on a case by case basis. With MoxDuo IR i dont see the abuse question being as sticky as i once did. In fact the FDA has never mentioned IR products when discussing abuse. Perhaps more important is the FDAs general assessment of MoxDuo IRs advantages (efficacy and safety) over other products already on the market. I think all studies but perhaps mostly 022 talks to this point favourably.
The decision on Zohydro is still pending and due any day now. This will give us another look at how the FDAs 'case by case' treatment of opioids will actually work.
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