Biotech Values

[masterlongevity]

inferentially seamless adaptive designs do not require alpha spend, but operationally seamless sometime do.

And i agree with dew on his adaptive disease wrt SPA comment.

I have been to at least 2 type C meetings as a company where we proposed an adaptive design. THe FDA was weary but did approve after reviewing thoroughly the simulation plans. Simulation plans and adaptive designs plans are however all based on simulation. And very frequently the real word trial does not mimic the pre-specificed simulation that the FDA agreed upon.