RE:RE:BTD timeline...I believe that 67% number came out of a conversation between Theralase and the FDA from before the phase 2 trial started. It sets an unreasonably high bar for efficacy at one year. My guess is that the FDA was willing to commit to this number at that early stage because they thought the chance of Theralase achieving it was so minute. Merck received full approval from the FDA after achieving less than 20% CR at one year. Accelerated approval sets a much lower bar than full approval as the FDA makes clear. For accelerated approval a clinical benefit does not even need to be demonstrated. All that needs to be achieved is a surrogate endpoint that predicts a clinical benefit. Achieving a 20% CR at 360 days would do this in spades. In my opinion Theralase will achieve double that number at a bare minimum. We don't know what conversations have been going on between the FDA and Theralase, but we do know from the recent timeline that Theralase estimates commerciation will begin at the start of 2023.
enriquesuave wrote: I believe that 67% or better was for AA not for BTD. But later they changed it to "significant efficacy " as potential for AA. BTD could be applied for at any time we have 60% CR on evaluable Optimized patients and 18% PR with a potential of up to 83% so far. Numbers can go up or down 10-15% at this time point depending on outcome of next 25 patients. IMO. Of course for AA we would need a significant amount of those patients to remain CR at 12-15 months. We shall hopefully see this in next few months .