RE:RE:RE:RE:RE:RE:RE:RE:How long to BTD and then AABased on FDA guidance, Mr. Uddin expects Theralase to apply for breakthrough designation for Ruvidar when it achieves a complete dataset of 20-to-25 patients during a follow-up period of 450 days. To date, Theralase has reported that it has 12 evaluable patients which showed a CR of 67% at day 450.
Looks like Research Capital is assuming that we need at least another 8 evaluable patients before applying for BTD. Again to my point if a patient drops out before 450 days they apparently don't count them and according to the Swimming Plot it will take many quarters to get those 8 patients.
What does the Secondary objective as currently laid out actually measure?
As best that I can tell it is the durability at 450 days of the CR for those that stay in the study.
Wouldn't it be more relevant to measure the durability of anyone that achieves the Primary Objective at 450 days?