RE:FDA to speed up approval processThe below quote is probably what is holding up the Ph2 application. If P5 and P6 show no recurrence then TLT applies for fast track approval/expedite review with smaller Ph2 trial saving $$ and time. I mean really why apply for a full blown Ph2 now when you can wait a few weeks and maybe apply for fast track approval.?
goregil wrote: Drugs that have been granted breakthrough status are given priority review. The FDA works with the sponsor of the drug application to expedite the approval process. This expedited process can include rolling reviews, smaller clinical trials, and alternative trial designs.[9