1. Nobody expected a mid-January reply date. End of January, yes in the best of all outcomes. Obviously there was a response back that was required, hence the delay.
2. "Is there a problem with the submission?" Well, how do you define problem? Yes, obviously there was an addressable problem because it wasn't granted in 45 days. It seems obvious that they replied and addressed this. The revised IDE, though separate is related and it's submission implies that they have addresses ALL questions. Including replies on the HUD.
3. Why repeat the erroneous conclusion by Greene? Jason has already pointed out that this is not the case, per company remark. The 1/24/13 date did not reset the timetable. March 9th means nothing.
4. i beg to differ that there is a risk the FDA has negative news. Look carefully at the circumstances and may I refer you back to Hess' statements. Transfer of information is completed. Any questions have been addressed. Negative would have been an outright rejection, and that didn't happen.
5. The fact that the company has submitted a revised IDE says they are wrapping up the final details, and you can certainly conclude that they would not have done so if the remaining HUD issues were not sufficiently addressed.
The run-up through March is the real deal before the big news, IMHO.