Giant. I'm not entirely sure whether I can fully answer that question. The only opinions I have seen reported in the past for medical devices are positive opinions. However, I seem to recall that in at least one of the historical situations a second round of "outstanding issues" has been sent to the company even though it is outside the 210 timelines.
Might need to do some more research on that and get back to you.
Rev
TIS Price at posting:
30.0¢ Sentiment: Buy Disclosure: Held
