RE:RE:Preliminary Breakthrough Therapy Designation (BTD) AdviceThe pre-BTD option certainly fine tunes the process & helps minimze the possibility of having to re-submit a BTD request in the event of a first-time denial (i.e. due to inadequate number of patients reported, inadequate data to support "preliminary clinical evidence"). This preliminary option takes a big burden off of the FDA & sponsor...would hate to have to file more than once. JMO.