Cel Sci Corporation (CVM)

[lightrock]

Looks great !

Again, the only thing I would add, and for two reasons, is a parameter for "% responding".

Reason 1 is to get a feel for the confidence in anticipation of published results.

Reason 2 is so this work will continue to be useful after the published results. Why? Because the published results should contain "% responding" ORR... and that, in turn, should carry weight as to whether or not the BLA filing will be expected to be successful.

For example, say we only make a 7% differential is overall survival, but the ORR is 100%... as well as positive secondary end-points.

Compare that to 9% differential and 20% responding. May look fluke-y to regulators.

If you do it you'll see (no pressure) that the OS assumptions + dropout assumptions + ORR assumptions are "the" triple constraint
( at certain thresholds )

When I did that, the worst possible case of selecting parameters that were still barely acceptable to reason left us at 11.25% differential.