Replies to post #31176 on Biotech Values

[gofishmarko]

Re : DNDN

Has all followup from 9901 and 9902A been completed ? If not , isn't it possible that they may gather additional supportive survival data by waiting until the mfg part of the BLA is ready ?

[iwfal]

If DNDN did that, they'd be completing a filing that shows pieces of efficacy across different stages of disease, hoping that the FDA would consider it whole.

I would look at it differently - that they are asking for approval of 9901 and P-11 would be supporting data (vs contradictory data in the event of a complete bust).

As you know I actually consider favorable data in multiple stages to actually be stronger data than, say, two trials in one stage. But on this I think we will agree to disagree.