RE:RE:RE:RE: FDA has refused request for approval of deviceWell, the Oppenheiner analyst predicted no FDA approval in 2019 - well done Sir! So management cannot be surprised and must have been making contingency plans over the past several weeks. I look forward to management's prompt assessment of the decision and how it plans to respond to this USA issue. It is positive that the FDA suggests that HSM could try again provided that it solves the "sham" issue - not easy!
prokofiev wrote: Very surprised myself. I guess the focus will now shift entirely to Canada, and EU/Australia submissions. If they can accelerate the Canadian deployment and get the other approvals, I believe we may bounce back some, but who know.s
The FDA might allow them to do a one-arm trial with physical therapy alone, and compare it the results of the previous trial. That would likely be much less costly and take a lot less time than redoing a trial (PT vs PoNS). Who knows until they meet with FDA again.
In any case this is a big
disappointment... Especially as patients that are being treated in Canada are seeing great benefits from the therapy. Why limit its use if it does no harm... but I guess the FDA sees it differently... Prokofiev