and here's the burley:
During the Company’s most recent FDA review meeting, QRxPharma presented a position that although
the Combination Rule does not require a demonstration of greater efficacy or safety, the data submitted to
date indicate a safety advantage for MOXDUO compared to either morphine or oxycodone alone. Results
from Study 022, which demonstrated that oxygen desaturation was less severe with MOXDUO than with
oxycodone or morphine, were presented to the full review committee and noted with interest. The FDA
recommended the Company provide a more extensive analysis of Study 022 when the revised MOXDUO
New Drug Application (NDA) is resubmitted
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