If everything was fine, IDE would be approved. Everything is not fine as the company isn't sure what more the FDA requires in the documentation. Hopefully, this issue is cleared up quickly, and they can re-submit the IDE and get it approved.
Dr Korenko is letting us know everything is fine in the IDE submission process. These prices won't last long,,,, a 40% drop was a huge overreaction imo.
Yep,1.5 years later, everything is fine! Just ignore the failure and the 50% decline since then! Love how you people see "signs" in anything and everything! You do this because you can't understand science, so this is all your have!