Biotech Values

[rstor1]

>> Makes you wonder if you could use the same trial to run two or more NDA's - one for all brain cancers, one for breast->brain, one for lung->brain, etc. <<

If the bifurcation is done retrospectively, it’s the same problem all over again, so the short answer is No.

But have you ever seen it done prospectively?

Would the FDA not allow it?

It seems that if you could choose a couple of likely subgroups in the context of the larger trial, youy might have some additional filing expenses, but you might save the cost of additional trials.