Replies to post #141555 on Biotech Values

[Summer2762]

In order to beat 0.01 p value with 40 events they would need 'only' HR=0.45. I.e. better than 2x, but not much.

Dont forget that the co changed the primary endpoint to PFS in TWO co-primary populations. Since they changed the primary end point, I expect the co to PR using the new primary endpoint. So this 'doubling the PFS' must be in these two subpopulations. Also, since they changed the primary endpoint, I agree that we might see statistical significance.

[biomaven0]

In order to beat 0.01 p value

This is a subgroup of a moderate sized Phase II - no way they they could reasonably hope for that sort of p value.

I'm assuming they are viewing this as a hypothesis-generating trial to enable the second part of their trial. So that just means you need a decent signal, not a highly significant result.

Peter