RE:RE:RE:RE:RE:This is what I want to see very soon.Thisguyiscool wrote: FDA approval is not required for aristotle, we may seek it out in the future, there are pros and cons, was discussed when Tripp answered a question from Echelon on the last call.
Skrit37 wrote: Skrit37 wrote: Skrit37 wrote:
Obviously this if for Aristotle
This is a good one too....( https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program ) How do we not or have not applied for this already...companies that are not anywhere near commercialization have it already....this is key in accelerating the slow fda approval process....
Before i bug IR about this..has anyone previously inquired about this program?....i think this is extremly important for our future growth....No need in double asking if its been asked before from someone reputable on here......I know they know about it...because its in the crystal company report ,under our competition companies.... Thanks Oh and right back at ya Jonnyboy85....
For sure it is
not required..I never said it was......
Mr Tripp had mensioned in that specific interview that there is no need to have FDA approval to be commercially succesful...which is fine....but he also said that if there are indications that our
competition is seeking it...we should persue it seeing that we will hopefully be first to market.....................so as i said before ..if you read the Crystal Report under competion companies...there are a few direct competitors that
ALREADY have FDA Breakthrough Device Designation.....and we should ....or already have requested this and hopefully will hear soon..asking the FDA for Breakthrough Device Designation does not cost tens of millions of dollars.....once we get the designation..then you revisit the actuall approval...but at least you have the designation in your back pocket and stay on par with our competition...