A rock-solid BTD application.If you look on the regulatory timeline on page 14 of the last Corporate Presentation 03,19,2024.
You will see that the '' Health Canada and FDA marketing approval is projected for end of 2026''.
In this link...
https://journals.lww.com/oncology-times/toc/2021/11050 Click on '' Rethinking FDA's Breakthrough Designation''
Second paragraph...
It is said'' BTD has shortened the time from submission to approval for oncology therapy by a median of 2.3 years compared to products without BTD''.
Let's see...
Dec 2026-2.3 years= Sept/Oct 2024.
TLT is still ahead of a normal BTD approval timeline by a few months.
I prefer that TLT take its time and do not make any major mistake in its BTD application.
A good exemple of a company that wanted to go to fast is ImmunityBio(N-803+BCG).
In 2021 ImmunityBio SP was at $40.00 ,then ImmunityBio started making mistake and the SP droped by 90%...Note; ImmunityBio is being sued by investors for ignoring Good Manufacturing Practice.
A word of advice to TLT...
Take your time and give the FDA a rock-solid BTD application.
If you do...we will all win.