RE:RE:RE:Higher efficacy numbers soon?
ScienceFirst wrote: They cannot cherry-pick but they could probably start their pool of patients with an offset as the FDA never said "the first 20-25 patients".
No matter what, we already have acceptable Numbers.
I'm honestly surprised the FDA would even consider the first 12 for any type of designation/approval (BTD, AA, etc.). In my view, the originally flawed protocol somehow bypassed the watchful eyes of multiple experts/groups, including the IRB/FDA...& it's uncertain to me who or which PI specifically caught the error. Nevertheless, the modified & correct protocol was approved to move forward as it replaced a sorely inadequate protocol with a scientifically sound one. Regardless of the regulatory oversight, the FDA demands scientific soundness for all clinical trials it reviews. Now that TLT has established such soundness, it makes perfect sense that the FDA follow the same stringent standards in their decision-making & should therefore disregard any data that could be considered skewed/unsound.
I would also think/hope that an optimized vs non-optimized differentiation will be made moving forward in any significant public forum (i.e. upcoming AUA mtg & others). Imo, the "scientifically sound" data should be the only data viewed/presented in any such public forum, & certainly the only data that is used for future publication. If we could only discard the first undertreated 12, the extra percentage points gained in CR% at this juncture could have significantly greater impact on those of influence & those who will hopefully one day adopt our ACT. All imo.