RE:The FDA
Oilminerdeluxe wrote: Just a thought. Can the FDA say "Ok this looks interesting, but first give us 12 new patients that were not treated the wrong way. Then we can discuss the BTD." ??
Hopefully the ones that were treated the right way will be enough for them, but I figured I could ask the question anyway.
They did give them 12 patients treated the right way. 13~ 25. The FDA has issued the Fasrtrack designation and that gave us closer and more frequent contact with them and as stated by SF , it seems the Breakthrough designation will be received after Dec 2022 and commercial approval early 2023.