Good news its on point of being filed by Andon
Reading that announcement they are making sure everyone knows this is a lodgement backed by 20 years of previously FDA approved tech, so it reads as a fait accompli. Presume turn around time should be short given its a device not a drug and FDA should have prior knowledge. Wondering if they are going to be asked for some trial data though.
Might grab a few more at these prices. Once approvals through, this should turn fast
Add to My Watchlist
What is My Watchlist?
