RE:RE:The Forgotten Chart…
Hi Pandora....It would be helpful to get clarification on how the FDA plans to determine if we are BTD qualified. Should the first 12 undertreated even be considered? Imo, they shouldn't. Not only does this subset of patients "not" represent the true protocol/dosing for which we are seeking an approval, their results more than likely negatively impacted the complete & durable response rates....all imo. Furthermore, these 12 represent ~half of the total patients that would be under review by the FDA in their BTD decision-making.
This part of the trial process never made a lot of sense to me, especially if the first 25 patients being considered do not meet a minimum efficacy threshold. I imagine the FDA at that point would await results on a total of 20-25 "fully optimized" patients before further review. Of course, such a unique ACT approach has to come with its unique decision-making circumstances...never fails.