Biotech Values

[poorgradstudent]

>My personal speculation is that they are waiting for P-11. If P-11 is a complete bust they may well choose not to file.<

This is interesting. If you're looking for efficacy support from a trial in a different stage of disease, then doesn't that imply that you feel the efficacy from 9901 + 9902A is not sufficient?

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 think that's an extremely unlikely means of convincing the agency. If anything, I would think that DNDN would be complicating their submission / reducing chances of approval with such a strategy. Inevitably, the more data you add (especially across stages of disease), the more possible questions you allow to be unearthed.