InvestorsHub Logo
icon url

ANTman2015

04/12/10 12:20 PM

#13383 RE: matrix8727 #13382

As i said before, why would there be any real movement.
The actual filing (the fifth?) was a non event. Just because they were able to actually make a deadline, is not a market mover.
there may be a little movement the closer we get to an anticipated response date from the FDA. Since approval is not certain, the move will be slight.
Nothing worth talking about will happen till after we hear from the FDA.

icon url

IMGGorBust

04/12/10 12:25 PM

#13385 RE: matrix8727 #13382

I don't think it's going to take 30 days this time. I think it could be a very quick turnaround since all of the other questions were addressed during conference calls with the FDA. The only remaining item was whether the Radiologist Review would confirm that the images from the DViS are comparable to the predicate devices. The report(s) from the radiologist are not so complex that it will take the FDA much time to consider them. I am certain the radiologists (at least two of them) gave the DViS high marks. If that's all that's left, this should be a very quick turnaround. In fact, I wouldn't be shocked to get approval by the end of this week. I don't really expect it this week, but I wouldn't be shocked either. I would not try to "time" the entry here. The difference between pre-approval and the minute after approval (when they first allow the stock to be traded again) is going to be astronomical.