RE:RE:RE:Half Of Breakthrough Designations Have Resulted In Approval
Laser, while i don't typically agree w bencro. BTD still needs to be requested even if you have been approved for fast track as fast track has a lower threshold for approval. Most companies initially apply for Fast Track designation and later submit a request for Breakthrough Therapy designation as development progresses. As far as I know, TLT has not made the BTD request yet, at least they have not made it public. Once the request is made they have 60 days to respond and BTD also has a rolling review. I am far from an expert, but just because there is a rolling review for FT, that doesn't automatically give you rolling review for BTD w o the appropriate request. Sorry, my highlighter isn't working today :)