Indeed, and for anyone trying to make sense of the latest tweets, I dont think they would have mentioned the Breakthrough Device Application (in the way that they did) If it was a no-go.... If BDA classification was denied I think they would have just said so.
1/2... We've been working with the @US_FDA for the past few years to secure our Investigational Device Exemption ("IDE") for #Human Applications of #RadioGel™.
The Breakthrough Device Application ("BDA") is a 'fast-track' program to help expediently achieve that objective. pic.twitter.com/ItKMsZgsNd