Hi DS, your opinion is definitely correct. The August meeting...

Hi DS, your opinion is definitely correct. The August meeting will clarify details of the CRL and determine the next steps. QRx does not know for sure if further clinical trials will be required (if required means it is more likely that the company will need to raise funds). However it apparently has additional data and analyses from study 022 (respiratory depression) to forward to the FDA prior to the August meeting.
Bioshares points out that no manufacturing deficiencies were noted (common with CRLs) and no risk management concerns were raised.
The overall gist is Moxduo IR is approvable but investors should sit on the sidelines until clarification from the FDA comes through.