RE:BTD timeline...Thank's Pandora & Enriquesuave for the clarifications...
It is not always easy to interpret the BTD FDA process.
In my post the big word is "
predict" "Reasonably likely to predict a clinical benefit" Predict = The prediction of future behavior.
My point is that it is the FDA that has the last word.
Because of TLT cancer treatment " immune response" the FDA could come to the conclusion that all the data to date(including the 23 optimized patients CR% data) could
predict that the 180,270,360 days CR% could end up being over 60CR%, if so then the FDA will render a BTD decision accordingly.
1) For the FDA granting a BTD request for a cancer treatment that has a very high safety profile(like TLT) is easier as it does not represent a big danger for the patient if the treatment doesn't work.
2) BTD approval by the FDA does not mean that TLT phase 11 trial will be approved, after the BTD approval TLT must continue to provide good CR% results or TLT could see its BTD approval revoked by the FDA.
wildbird1 wrote: In the May 19,2020 Pressrelease, TLT received the FDA authorization to proceed with Phase 11 trial.
(Quote) Phase 11 has a secondary endpoint of duration of CR at approximately 360 days post-initial CR (End of Quote).
The above 360 days CR is for the phase 11 trial not for the BTD approval.
Question..For the BTD approval is it the 90 days CR% or the 180 days CR% data that will be used...????
The only timeline from the FDA site for a BTD approval is that the BTD request must be made before the end of the Phase 11 trial.
From the FDA site (Quote) For a BTD approval, a cancer treatment need to have an effect on a surrogate endpoint or intermediate clinical endpoint considered reasonably likely to predict a clinacal benefit (End of quote).
It does seem that the timeline for a BTD approval is the prerogative of the FDA, but we must assume that the minimum timeline is the 90 days CR% data.
90 days CR% Data...
From Eoganacht post April 18,2022..
Potential CR% = 82% at 90 days on 23 patients.
We know that the FDA is asking TLT for a CR% of approximately 66% on 20-25 patients for a BTD approval.
A potential of 82%CR at 90 days on 23 patients is huge.
If the 90 days potential 82%CR data on 23 patients is reasonably likely to predict a clinical benefit, as we speak the BTD approval request could have already been made a few week ago by TLT.
The FDA has 60 days to answer the BTD request, minus how many days ... ????