The price is up due to the expectation that FDA would approve it. However, how can one be sure that FDA would approve it. It is usually they wouldn't approve. Many would be disappointed.
from the trend of the stock movement, I do not expect any surprises. Also, perhaps the whole space is not that good. Look at CYNO, good earning, yet stock did not pop, actually down. I suppose it is not good enough at 19% revenue growth.