70% of TLT patients are CIS...First...what is a CIS NMIBC patient.
In this link....
https://content.iospress.com/articles/bladder-cancer/blc190236 Under summary..." The genetic of CIS is linked to aggressive, and at times resistant desease, with increased cancer progression and associated clinical
worse cancer specific outcome".
In short...being a CIS NMIBC patient is very bad.
If you check the last Swimmer Plot, you will see...
-That 70% of patients treated by TLT are CIS NMIBC pateints.
-And 65% of patients treated are over 70 years old.
-And 37% of patients treated have received between 13 & 32 BCG treatments(over 15 is very bad).
That is what you call very feeble patients to treat.
For these CIS NMIBC pateints...
-Surgery doesn't work.
-BCG doesn't work.
-Chemotherapy doesn't work.
-Radiotherapy doesn't work.
-Keytruda...not very good and most of all very costly.
-Now N-803+BCG is out(for now.. manufacturing issues can be solved).
As we speak the FDA know about TLT Ruvidar(the FDA gave TLT Ruvidar FTD(Fast Track Designation) in Nov 2020).
Because of all the above, there is an urgent unmet need for these CIS NMIBC patients, and the FDA BTD is to fill an unmet need.
Interesting time ahead for TLT Ruvidar, and BTD and or AA approval.