Is this where a Conditional Approval approach could be helpful? Avoid post hoc analysis but allow for movement forward w confirmatory studies to i.d. responders? I don't know all the answers, but we certainly need to figure out how to get to scientific truth faster.https://twitter.com/onein300/status/1224242822963978240 …
Need confirmatory before any approval unless hypothecated post analysis proven already. Conditional approval path vitally needed in USA. We have conditional approval here, & for eg, post P3 Nurown, if proven in even small percentage, that would be how it could be triggered here!
