RE:RE:RE:RE:RE:Quote by Warren Buffet
CAinPlap wrote: I would like to have data at 450 days for 25 patients post undertreated 12 so 37 total. That way the FDA will have data on 25 that followed the actual protocol of the trial. I suspect that may be what they have been advised to do in their consultations with the FDA.
Imo, the end result of the underdosed 12 has nothing to do with their data results & more to do with shortening the timeframe to that "25 patient" threshold. When considering the first 25+ patients treated (non-optimized & optimized), the overall CR% is ultimately sufficient to qualify us for a BTD imo.
If the above is the case, however, the FDA would need to be very clear on how the data of the underdosed group is announced/published (I.e. the results of the initial 12 patients treated were based on an original protocol that was later deemed inadequate & subsequently discarded for an optimized & final protocol, which was put in place at "x" point in time...). The FDA needs to inject scientific clarity on this matter early on, or they should completely disregard the underdosed 12 altogether. If there is any delay in a BTD announcement, the above data discrepancy would certainly explain it.