RE:reading george's letter againSpoke to George- FDA raised questions over the past weeks (months?), which is not unexpected, but VPT team has responded fully. Given how the new team prepared and got CE in such a short order, I have great confidence that the responses provided should not be an issue.
IMHO, unless FDA somehow comes up with more question(s), we should have a positive outcome over the next 10 days. When I called the company back in Feb, they were expecting 60-90 days approval time frame..I would give the story a few more weeks to see how this unfolds.