Theralase Technologies Inc. V.TLT

The FDA-BTD approval process...

[wildbird1]

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.

[CAinPlap]

You have a much less jaded opinion of the time it is taking the powers that be to get this across the FTD finish line. Too many powerful entities that stand to lose alot of revenue if/when we are approved. 

[BlueFranky]

Thank you for your thoughts wildbird . It stands to reason and as has been discussed recently, I too ponder the likelihood that these  questions/clarifications are putting more weight not towards a potential BTD designation, but also an expedited AA designation and future SOC possibility we may have on our hands. Has has been pointed out in the last few days, while we are novel, we are

[2b7f6fab]

Agree the FDA wants to review this newer treatment thouroghly,  They don't need a flip flop scenario where they green light it and then have to retract.  However, PDT has been around for decades.  What's different is Ruvidar.  Considering the success to date i wouldn't be surprised if Theralase is granted AA along with the BTD.  The waiting is certainly