Cel Sci Corporation (CVM)

[przgwxl]

@Fosco

Stopping early part 2.

I ran the Cel-Sci model. In Sept, 2019 there would have been about 200 events in the control arm. Both criteria for an early halt would have been met - kind of a no-brainer. Hazard ratio around 0.5, very low p-values. This assumes a dropout factor of 18.9%. The point is, the model used with Cel-Sci survival curves would indicate the trial could have been stopped last fall.

So maybe Fosco has it right - even Cel-Sci baseline is too pessimistic about SOC survival.

Alternative explanations are

1) The company just did not want the trial stopped, because MK is novel, etc etc.
2) Worries about the participants recruited under the old CRO.
3) Larger numbers of dropouts

These factors will simply be unknown until the data is presented.

If the dropouts are equal in each trial arm, dropouts will affect the length of the trial but not the treatment effect or the p-value. It just takes longer to get to the end.

I could try a run where I threw out the patients recruited before 2014. Might try that.