Replies to post #104121 on Biotech Values

[jq1234]

I agree this is a very creative trial design. It basically put several mini clinical trials into one single trial based on disease phase and mutation, which could satisfy both FDA and EMA. I would not be surprised they wouldn't get all cohorts in eventual label.

[DewDiligence]

ARIA—I like this design as it may reduce the risk in terms of gaining approval in one or more cohorts as opposed to the all or none that is more typical in registration trials.

There would seem to be only two (overlapping) cohorts where there might be enough data to get subgroup-specific FDA approval: i) chronic phase; and ii) T315I+.