RE:RE:RE:Good discussion boysDJDawg wrote:
I think that 20-25 patient data threshold is out of date. I believe that when they had the 2/3 CR's in the phase 1b they were told that IF the data continues to look this good over time then 25 patients would be sufficient. 66% CR carried forward to 450 days would be good enough.
Then came the undertreated patients and the CR's changed so all bets were off.
Once again dawg your insights fill in some of my confusion gaps with this investment and why the BTD timeline was pushed out. So, this is far less about FDA goal posts moving and more about not obtaining similar results to ph 1b. Even if we consider just the optimized cohort of 32 patients treated, while the results are very good they fall short of that very high bar. But with so much collected data on 62 patients, trend and statistical outcome analysis should enable stronger conclusions about safety and efficacy and argue strongly for BTD. Would you agree or am I just exhibiting overt investor bias?