InvestorsHub Logo
Post# of 1647
Next 10
Followers 144
Posts 15541
Boards Moderated 1
Alias Born 02/04/2011

Re: Vitamix8173 post# 1174

Wednesday, 03/01/2017 2:59:23 PM

Wednesday, March 01, 2017 2:59:23 PM

Post# of 1647
agree, the FDA couldn't give clearance for general pain treatment since their current rules only allow them to give indications of use based on clinical data.
the real world evidence rule change is not finalized yet (I suspect Trump will have it accelerated) so the UK survey is not admissible

it seems the company got FDA to say that if they had three different body parts supported by clinical evidence then they would issue a general clearance. That in itself is a big decision.

typical turn around for additional 510ks for recently cleared predicates is about 80 days I think - again Trump may speed things up

Join the InvestorsHub Community

Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.