Hat tip (again) to Huntlardo

[biopearl123]

A respected poster on twits has suggested that at interim the company may remain blinded to the data. The DSMB can recommend stopping the study for efficacy, for futility or recommend continuing the study to completion. If they recommend the latter, then for the integrity of the study I suppose he may be right. If the recommendation is to continue the study it would suggest that there is a strong possibility of reaching some or all of the endpoints but only after more data has matured (50% of patients have died projected to June 2028). Just imagine the groans (and stock sales) if we have to wait two more years of uncertainty. If the DSMB recommended stopping the study for efficacy at interim the its probably a home run and surely at that point the company becomes unblinded. Thanks Huntlardo for pointing this out. We have the Mascharanhas study and the Kuykendall study as positive hopeful data to date. The company says they expect the study to go to completion. I don’t know if this reflects optimism or pessimism. It could be the desire for a more complete data set. We should know soon. What does a home run look like? HR of 0.6 (or better) and a p value of <0.01, my best guess.

[rccola335]

back when Scarlet was in charge
-Geron said if the interim phase 3 data was strong they would apply for approval based off that
- Scarlet also said he felt the phase 3 data had good chance to be better than phase 2 because they learned who the responders would be

[biopearl123]

RC, that he did and so did Dr. Rizo

[lacour_98]

And Dr. Feller too, but Geron has to have access to the data and the only way it seems is for DSMB to be satisfied with interim data, not necessarily halting the trial, but to unblind the results to Geron. Maybe Geron would want to continue the study while seeking NDA approval.