Replies to post #119885 on Biotech Values

[AlpineBV_Miller]

While I realize that you will never believe me, nonetheless it should be stated that adaptive trial designs do not save alpha spend except to the extent that:

You're right. We're going to have to agree it disagree on this one.

[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.