RE:RE:1 of 2 options for Breakthrough designation applicationConsultant99 ... It's all about material news or not and possibly also about getting awareness, depending at which stage one is.
For example, TLT never news released the application for FastTrack. Neither ImmunityBio. Neither for IND.
But TLT and ImmunityBio both news released being granted FastTrack. And Breakthrough (for ImmunityBio).
But clearly, news releasing submission of Breakthrough designation could get TLT additional visibility, before the FDA decision.
Note that material news is at the discretion of management, as per TMX rules. But final decisions cannot be hidden.
Couple of examples: