The FDA-BTD approval process...My thoughts about the delay of TLT-Ruvidar BTD by the FDA.
-It doesn't matter how good TLT staffs is, TLT is dealing with an innovative treatment(Ruvidar) that has never been used in a human phase11 trial.
-The FDA has highly qualified scientists whose job is, to have a very cautious approach toward new treatments protocol that have never been used before on cancer patients.
-The FDA being very cautious = more questions(or clarifications).
-In 2020 when TLT submitted an application for FTD(Fast Track Designation), the application was first denied, the FDA citing certain improvement required to the application.
TLT did provide the improvement and the FTD application was granted by the FDA.
-The BTD is a much more complex process than the FDA-FTD, and the FDA asking questions (or clarifications) was not a big surprise...it was something that was almost unavoidable.
We are on the verge of being rewarded for our patience.