RE:As per Fred ! New TLT deck April 22 2022 !When a company make "projections", the projections timeline will usually be for the worst case scenario, in order not to mislead investors on the timeline.
From the FDA site...
(Quote) " The Food Drug and Cosmetic Act (21 USC 356) states that a request for Breakthrough Therapy Designation may be made concurrently with,
or at any time after, the submission of an application for IND (End of Quote).
IND = Investigational New Drug (phase1,2 trial).
The above doesn't mean that TLT has already placed a BTD request, what it does mean is that from a legal standpoint a request could have already been made... if TLT has come to the conclusion that the data to date justify a BTD early request.