Avid Bioservices Inc (CDMO)

[exwannabe]

Re: numbers and predictions.

Though I think GolfHo's method should work reasonably well, there looks to be a mechanical error when he gathers the table describing an event rate based a similar trial, then adjusting for median.

Look at all the 20 month survival values. On the pattern trial GH uses, the 20month survival is about 30%, yet GH's is 4% for the placebo arm. These numbers do have slightly different meanings due to drop outs, but that effect will be minimal.

Perhaps you or GH could dig up the post where he has his final calculation of this table so we could discuss it?

With the enrolment curve reasonably well known (still some wiggle room between "fast" and "slow" ramping, but not much). And with the event targets known, it is possible to get reasonable estimates on when the 1st look happens for various MOS guesses.

FWIW, my estimates for SUNRISE with various successful (3 month MOS advantage) curves has IA-1 around late spring - early summer. I used enrolment ramping somewhat faster than GH's and events based on constant hazard model. Not trying to say this is "right" as there is still variation possible.

P.S: This estimation game is fun, but often ends up not being very accurate for many reasons. Will the curves have late separation (which is good, but not show up much this early). Could PD-L1 expression testing results effect trial selection (and who knows what that would actually mean). ...

So nobody should put much faith in any of this (and that certainly includes my post here).