Replies to post #34464 on Biotech Values

[DewDiligence]

> GPCB – What you know post facto does not alter what you should plan a priori. They could have just taken out an insurance [on hitting the PFS endpoint].<

Your point about a prior planning is of course valid in a general sense but, in this trial, GPCB was confident of the statistical power of the final PFS look even without the delay in unblinding relative to the original protocol. This confidence stemmed from: 1) Over-enrolling the trial (950 patients vs the 912 specified in the SPA); and 2) Reports from the DSMB that aggregate dropouts in the trial were tracking lower than expected beginning in the early months of the trial. In short, GPCB did not really need extra “insurance” for the PFS endpoint.

On the other hand, extra insurance for the overall-survival endpoint was very much welcomed.

>How did you find out about this?<

I’ve listened to every GPCB CC for the past couple of years. Regards, Dew

p.s. It’s worth pointing out that, in the very advanced disease setting in which the SPARC trial was conducted, “stable disease” is a something of a misnomer. In the control arm, 83% of patients progressed or died within six months and 93% progressed or died within one year.