Ann: QRxPharma Updates MOXDUO NDA Review , page-5

If the stock drops its only an opportunity to average down slightly (fr for me anyway). These situations are where you make your money. Biotech is littered with such hiccups, you have to be accustomed to this to make money from it.

Unfortunately there is a temptation to look upon these developments with only pessimistic eyes, however a couple of points stand out for me:
1. I am comforted by the fact that regular FDA engagement is happening (hence the clarification).
2. The oversight on QRX part is somewhat understandable given:
a) The volume of data submitted (remember only a portion of entrolments/patients were affected)
b) The data from some of these studies was never originally planned for NDA inclusion.
3. It is a good thing that the oversight was identified at this time rather than later or worse case - as the reason for non approval.
4. I am confident of JH/QRX capabilities; in my opinion they are top tier professionals.

All of this should be framed within the past events. Again, we should mindful of the fact that the NDA is unique (combo in same class) and the original knock back was biased around additional data only from pre-existing studies. No other notes to suggest differently or anything additional.