Biotech Values

[DewDiligence]

…it's inaccurate to suggest a SPA on an adaptive design is less meaningful than a SPA on a traditional design.

I stand by the statement in my prior post—there are simply more things that can go wrong (in the opinion of FDA reviewers) to invalidate an SPA in an adaptive trial than in a conventional one. When there are sufficient data on this to make a meaningful comparison, I’m pretty sure my contention will be borne out.

Having an SPA is always better than not having one, of course.