"This is a pretty big setback and is probably the main impetus for the sharp decline in the share price since the 9/11/17 PR, IMO."
EXACTLY - in your opinion. Convenient.
I'll state the very obvious since everybody is such a fuss over the recent set of events.
1. In case you don't know, you're invested in a biotech equity that has not product or no approval - YET. This means:
A. Volatility is king. End of story. So, remove your emotions.
B. Pre "material news", stock swings, either way are bullshite facades
C. When you hear claims of reasons of events, just opinions, not facts
So, summarizing:
1. Expect the unexpected until "material" event(s). This means the stock could just as easily go to $9+ in two days, for no reason at all.
2. If you need to sell now, I sympathize - that would suck.
3. Until EMA submission and EU approval, continue to expect volatility.