The first 25 patients.Here is a little challenge for anybody on this board.
Find just one PressRelease were TLT said that for BTD application, TLT need more than 25 patients data???
You wont find any, from the first day of phase11 trial,TLT has always repeated the same phrase.
" The company will compile a clinical data report for submission to the FDA in support of the grant of a BTD approval after the completion of the 450 days assesment for 25 patients".
Here are interesting numbers on the first 25 patients. I did use the same numbers as the last Swimmer Plot.
-CR at any point in time for the first 25 patients= 21/25 patients=84% CR at any point in time.
-Here is a number that went unnoticed, the response rate(patients that did respond to the treatment at one point in time).
100% of the first 25 patients did respond to TLT treatment at one point in time.
Some for just 90 days, but they still did respond. What would have happened if these patients had received a third treatment?
-For these 25 patients, safety was 100%.
Think about this...
As we speak the FDA has no treatment for the kind of patients TLT is treating( even Adstiladrin doesn't work, as patients who are immunosuppressed, or immune-deficient should not come into contact with Adstiladrin), TLT doesn't have this kind of restrictions.