RE:RE:RE:RE:RE:RE:Quote by Warren Buffet
CancerSlayer wrote:
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.
Re: a decision for an accelerated approval, data soundness is even more applicable & such a decision is based on a smaller subset of patients.... the first 12 treated should in no way be considered in that determination.
If the optimized data continue to trend favorably, I don't believe such a determination would pose any significant delays, especially if you were to consider our "two treatment only" efficacy, overall safety & the fact that currently approved therapies have demonstrated far less. We are also a highly differentiated/unique tech for this indication (I.e. not competing in an overcrowded therapeutic space like we see in immunotherapy, gene therapy, etc.) & we are also addressing a high unmet clinical need...not via a "surrogate" endpoint (I.e. lab marker, radiographic image, etc....often a poor predictor of clinical benefit), but an intermediate endpoint of actual clinical efficacy (more often a better predictor of clinical benefit).
If you take a look at the FDA/Biogen Aduhelm (Alzheimer's medication) fiasco, I don't see how TLT could not be considered a serious candidate if current trends continue. All imo. Eoganacht has it right imo...the data so far is signaling a BTD is "a no-brainer”.