RE:How long to BTD and then AASo the FDA appears to have moved the goal posts such that the trial now includes only those patients that have received the Study Treatment as defined in the management notes.
In the BTD update the company notes the criteria:
Primary objective is CR at any time
Secondary is duration of CR at 12 months after initial CR.
Tertiary objective is safety.
BTD is available if certain criteria are met, which the FDA has previously defined to the Company as clinical data on approximately 20 to 25 patients enrolled and provided the primary Study Treatment, who demonstrates significant safety and efficacy clinical outcomes.
There is a table where these objectives are shown and of interest is the secondary objective where 10 of 12 evaluable patients have achieved this objective.
So looking at the Swimmers Plot and looking for patients having pending treatments or analysis ...
there are 2 at 360 days, 2 at 270 days, and 6 at 80 days for a total of 10.
The good news is that 9 are CR and 1 was CR now HG NMIBC
The bad news is that to get 8 patients across the 450 day finish line will take potentially 9 months plus time to gather medical files update the application submit it to the FDA and another 2 months before the FDA has to respond. That if course assumes no one else drops out before the finish line.
I have no idea the date of the data presented but assuming it was updated as of yesterday, we could be looking at Q1 2024 before we could complete the Secondary objective and get BTD.
What if anything am I missing or misunderstanding?