I have read all recent qrx announcements (some many times)and...

I have read all recent qrx announcements (some many times)and would love someone explain in simple layman's terminology what the relevance there is with providing the oxygen dataset to the fda.

Does it mean that without this data passing some sort of specific hurdle the moxduo treatment regime is unacceptable? Or is it just completing the entirety of the submission?