RE:RE:RE:RE:RE:Preliminary Breakthrough Therapy Designation (BTD) AdviceMy understanding is that FDA Pre-BTD communications are "advisory" which simply means the FDA review division agrees (or not) that the company's pre-submission materials and data meets some minimum threshhold to move forward with an actual application for BTD.
Think of it like a checklist for gathering documents and information when applying for a mortgage. Completing your checklist just means you have all the necessary docs and information to apply. It does not mean your application will be approved.
A pre-submission receiving the go-ahead to apply for BTD is still speculative in the sense that the application could ultimately be denied. As such, a pre-submission is not "material information" as that term is defined and used in securities law, and the company is thus under no obligation to report it.
It is a successful application approval and the actual achievement of Breakthrough Designation which is material and must be reported in a timely manner.